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"Peptide King" Pietro Simone Is Bringing His Treatments and Products to the US – NewBeauty Magazine

By daniellenierenberg

He grew up in Italy and now calls Londonwhere he runs his eponymous clinichome. Meet Pietro Simone, the aesthetician turned product-formulating wiz hoping to turn Americans on to the power of peptides and Italian-powered ingredients with the release of his two skin-care collections this fall.

When Simone set out to create his lines, he wanted a specific formulation something bio-recognizable for the skin that consumers can use at home and I can use in the clinic. The result: An edited-down selection that is pure and continuously evolving. I dont believe in creating 125 products; I believe in the evolution of the products, he says. I can always improve the formulation, and I can add or remove ingredientsthat is especially important when youre dealing with high-end actives.

The proprietary Italian Bella Complex, found in all of the products, reads like a regional passport: The indigenous-toItaly actives include the antioxidants of Puglian tomato seed and Sicilian almond oils, nourishing Tuscan grapeseed and Vinnaciolo oils, Vesuvian apple, an anti-glycation powerhouse, and stem cellrich edelweiss from the Italian Alps. You can go and have pizza wherever you want, wherever you are, but that doesnt mean it will be good. The same goes for skin care.

Simone refers to a good peptide as the Chanel of skin care. (Rumor has it that the kind he uses costs $5,000 a gram.) If youre using really great peptides, youre communicating between the cells, and that is the secret to boosting collagen and making the skin stronger, he explains. Its very scientific and tricky to find the right mix of proteins and amino acids for real results. Its not an easy compromise, unless you want to sell a cream for $20,000.

In addition to the release of the new collections, Simones facials will be available at New Yorks Greenwich Hotel and the Parlor this fall. At the Parlor, hell also be displaying something special: an active wall educating clients on exactly which ingredients are in the products and the benefits associated with each. When you go for a facial, it should be more than just applying a bunch of skin care, he says.

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Rejuvenating Austin spa puts holistic health and wellness on the table – CultureMap Austin

By daniellenierenberg

Every day, the average woman comes into contact with more than 500 harmful chemicals before she even leaves the house. After being absorbed into the body, these toxins can lead to health issues basically the opposite of what everyone is striving for right now.

EvolvE Cryo + Wellness founder Shannon Maddalena has made it her mission to soothe, revive, and nurture the body, from top to toe and inside and out.

"We strive to create a dialogue around health and holistic treatments to help reduce cortisol levels, improve immune function, reduce pain and inflammation, and increase energy and quality of sleep," she says. "If we are on a proactive path to become and stay healthy, we avoid working to correct sickness. If your immune system is prepared to fight off whatever the world throws at it, it is primed to do its job: keep you healthy."

Maddalena opened EvolvE nearly five years ago, and quickly became a go-to for Austinites looking for ways to clean up their bodies. Even professional athletes are on board the facility is the official wellness center of the Austin Bold soccer team.

But what really sets Evolve apart are its innovative treatments, all in a beautiful and relaxing atmosphere that send blood pressure dropping as soon as you walk in the door.

Here's a closer look at what is offered:

Infrared saunaThis holistic, comprehensive approach to detoxification can not only improve your skin's appearance, but also provide pain relief, improve circulation, support your immune system, and even reduce cellulite. Compared to a conventional sauna, infrared eliminates up to seven times more toxins by working at a cellular level, helping the heat penetrate deeper into your body and produce a more intense sweat. And with individual rooms, each session is completely private.

CryotherapyExposing your body to extreme cold induces a number of physiological changes. Initially, as the blood vessels constrict, blood moves away from the limbs and toward the vital organs. The immune system increases white blood cell count to fight viruses and bacteria, the circulatory system reacts to increased productivity, and inflammation and arthritis pain is significantly reduced.

In addition, the endocrine system jumps into action to release endorphins and norepinephrine that inflate "feel good" hormones in the blood stream. Studies have shown a reduction in cortisol and an increase in cold shock proteins, which protect the brain from both short- and long-term damage.

Body treatmentsThere's so much more than massage (though EvolvE certainly offers several relaxing options). The holistic treatments range from acupuncture, said to help with chronic pain and acute injury; to cupping, which increases circulation and calms the nervous system; to gua sha, a way to boost immunity and reduce inflammation.

There's as much science at EvolvE as there is Eastern holistic treatments, with photobiomodulation helping the body to absorb light energy to enhance tissue health at the cellular level. See? We really are just houseplants with more complicated emotions.

Skin treatmentsIt was important to Yarbrough that EvolvE only use the highest quality organic products featuring the world's most nutrient-dense, whole botanicals sourced from sustainable and ethical growers around the globe (and several local to Austin). Therefore, each signature skin treatment incorporates products that are botanically rich and nutrient dense, housing peptides, vitamin C, hyaluronic acid, marine algaes, and superfoods.

The Liquid Facelift, for example, infuses over 100 vitamins, minerals, and nutrients into the skin in an 80-minute treatment incorporating bioenergy, stem cells, and nanotechnology to brighten skin, reduce pores, and reverse the signs of aging.

"In the midst of a pandemic, there is a growing appetite for holistic health and a need to nurture not only the body, but the mind and spirit," says Maddalena. "We have to be our own advocates, because no one knows how it feels to be in our body. We know when something is even slightly off, and can take appropriate action from there."

EvolvE is located in the Austin hub of SoLA, just south of downtown at 3411 S. Lamar. Call512-326-2600 or visit its website to book a service.

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Impact Of Covid-19 on Cosmetic Skin Care Market 2020 Industry Challenges, Business Overview and Forecast Research Study 2026 – PRnews Leader

By daniellenierenberg

Cosmetic Skin Care Market Data and Acquisition Research Study with Trends and Opportunities 2019-2024The study of Cosmetic Skin Care market is a compilation of the market of Cosmetic Skin Care broken down into its entirety on the basis of types, application, trends and opportunities, mergers and acquisitions, drivers and restraints, and a global outreach. The detailed study also offers a board interpretation of the Cosmetic Skin Care industry from a variety of data points that are collected through reputable and verified sources. Furthermore, the study sheds a lights on a market interpretations on a global scale which is further distributed through distribution channels, generated incomes sources and a marginalized market space where most trade occurs.

Along with a generalized market study, the report also consists of the risks that are often neglected when it comes to the Cosmetic Skin Care industry in a comprehensive manner. The study is also divided in an analytical space where the forecast is predicted through a primary and secondary research methodologies along with an in-house model.

Download PDF Sample of Cosmetic Skin Care Market report @ https://hongchunresearch.com/request-a-sample/77005

Key players in the global Cosmetic Skin Care market covered in Chapter 4:HenkelNatura & CoKaoLaboratories IPRADMary KayBeiersdorfEste Lauder CompaniesCotyColgate-PalmoliveUnileverP&GShiseidoChanelJohnson & JohnsonAmorepacificRevlonKoseAvonLVMHL BrandsLOreal

In Chapter 11 and 13.3, on the basis of types, the Cosmetic Skin Care market from 2015 to 2026 is primarily split into:Anti-Aging Cosmetic ProductsSkin Whitening Cosmetic ProductsSensitive Skin Care ProductsAnti-Acne ProductsDry Skin Care ProductsWarts Removal ProductsInfants Skin Care ProductsAnti-Scars Solution ProductsMole Removal ProductsMulti Utility Products

In Chapter 12 and 13.4, on the basis of applications, the Cosmetic Skin Care market from 2015 to 2026 covers:Stem Cells Protection Against UVFlakiness ReductionRehydrate the Skin SurfaceMinimize wrinklesIncrease the viscosity of Aqueous

Geographically, the detailed analysis of consumption, revenue, market share and growth rate, historic and forecast (2015-2026) of the following regions are covered in Chapter 5, 6, 7, 8, 9, 10, 13:North America (Covered in Chapter 6 and 13)United StatesCanadaMexicoEurope (Covered in Chapter 7 and 13)GermanyUKFranceItalySpainRussiaOthersAsia-Pacific (Covered in Chapter 8 and 13)ChinaJapanSouth KoreaAustraliaIndiaSoutheast AsiaOthersMiddle East and Africa (Covered in Chapter 9 and 13)Saudi ArabiaUAEEgyptNigeriaSouth AfricaOthersSouth America (Covered in Chapter 10 and 13)BrazilArgentinaColumbiaChileOthers

For a global outreach, the Cosmetic Skin Care study also classifies the market into a global distribution where key market demographics are established based on the majority of the market share. The following markets that are often considered for establishing a global outreach are North America, Europe, Asia, and the Rest of the World. Depending on the study, the following markets are often interchanged, added, or excluded as certain markets only adhere to certain products and needs.

Here is a short glance at what the study actually encompasses:Study includes strategic developments, latest product launches, regional growth markers and mergers & acquisitionsRevenue, cost price, capacity & utilizations, import/export rates and market shareForecast predictions are generated from analytical data sources and calculated through a series of in-house processes.

However, based on requirements, this report could be customized for specific regions and countries.

Brief about Cosmetic Skin Care Market Report with [emailprotected]https://hongchunresearch.com/report/cosmetic-skin-care-market-size-2020-77005

Some Point of Table of Content:

Chapter One: Report Overview

Chapter Two: Global Market Growth Trends

Chapter Three: Value Chain of Cosmetic Skin Care Market

Chapter Four: Players Profiles

Chapter Five: Global Cosmetic Skin Care Market Analysis by Regions

Chapter Six: North America Cosmetic Skin Care Market Analysis by Countries

Chapter Seven: Europe Cosmetic Skin Care Market Analysis by Countries

Chapter Eight: Asia-Pacific Cosmetic Skin Care Market Analysis by Countries

Chapter Nine: Middle East and Africa Cosmetic Skin Care Market Analysis by Countries

Chapter Ten: South America Cosmetic Skin Care Market Analysis by Countries

Chapter Eleven: Global Cosmetic Skin Care Market Segment by Types

Chapter Twelve: Global Cosmetic Skin Care Market Segment by Applications 12.1 Global Cosmetic Skin Care Sales, Revenue and Market Share by Applications (2015-2020) 12.1.1 Global Cosmetic Skin Care Sales and Market Share by Applications (2015-2020) 12.1.2 Global Cosmetic Skin Care Revenue and Market Share by Applications (2015-2020) 12.2 Stem Cells Protection Against UV Sales, Revenue and Growth Rate (2015-2020) 12.3 Flakiness Reduction Sales, Revenue and Growth Rate (2015-2020) 12.4 Rehydrate the Skin Surface Sales, Revenue and Growth Rate (2015-2020) 12.5 Minimize wrinkles Sales, Revenue and Growth Rate (2015-2020) 12.6 Increase the viscosity of Aqueous Sales, Revenue and Growth Rate (2015-2020)

Chapter Thirteen: Cosmetic Skin Care Market Forecast by Regions (2020-2026) continued

Check [emailprotected] https://hongchunresearch.com/check-discount/77005

List of tablesList of Tables and Figures Table Global Cosmetic Skin Care Market Size Growth Rate by Type (2020-2026) Figure Global Cosmetic Skin Care Market Share by Type in 2019 & 2026 Figure Anti-Aging Cosmetic Products Features Figure Skin Whitening Cosmetic Products Features Figure Sensitive Skin Care Products Features Figure Anti-Acne Products Features Figure Dry Skin Care Products Features Figure Warts Removal Products Features Figure Infants Skin Care Products Features Figure Anti-Scars Solution Products Features Figure Mole Removal Products Features Figure Multi Utility Products Features Table Global Cosmetic Skin Care Market Size Growth by Application (2020-2026) Figure Global Cosmetic Skin Care Market Share by Application in 2019 & 2026 Figure Stem Cells Protection Against UV Description Figure Flakiness Reduction Description Figure Rehydrate the Skin Surface Description Figure Minimize wrinkles Description Figure Increase the viscosity of Aqueous Description Figure Global COVID-19 Status Overview Table Influence of COVID-19 Outbreak on Cosmetic Skin Care Industry Development Table SWOT Analysis Figure Porters Five Forces Analysis Figure Global Cosmetic Skin Care Market Size and Growth Rate 2015-2026 Table Industry News Table Industry Policies Figure Value Chain Status of Cosmetic Skin Care Figure Production Process of Cosmetic Skin Care Figure Manufacturing Cost Structure of Cosmetic Skin Care Figure Major Company Analysis (by Business Distribution Base, by Product Type) Table Downstream Major Customer Analysis (by Region) Table Henkel Profile Table Henkel Production, Value, Price, Gross Margin 2015-2020 Table Natura & Co Profile Table Natura & Co Production, Value, Price, Gross Margin 2015-2020 Table Kao Profile Table Kao Production, Value, Price, Gross Margin 2015-2020 Table Laboratories IPRAD Profile Table Laboratories IPRAD Production, Value, Price, Gross Margin 2015-2020 Table Mary Kay Profile Table Mary Kay Production, Value, Price, Gross Margin 2015-2020 Table Beiersdorf Profile Table Beiersdorf Production, Value, Price, Gross Margin 2015-2020 Table Este Lauder Companies Profile Table Este Lauder Companies Production, Value, Price, Gross Margin 2015-2020 Table Coty Profile Table Coty Production, Value, Price, Gross Margin 2015-2020 Table Colgate-Palmolive Profile Table Colgate-Palmolive Production, Value, Price, Gross Margin 2015-2020 Table Unilever Profile Table Unilever Production, Value, Price, Gross Margin 2015-2020 Table P&G Profile Table P&G Production, Value, Price, Gross Margin 2015-2020 Table Shiseido Profile Table Shiseido Production, Value, Price, Gross Margin 2015-2020 Table Chanel Profile Table Chanel Production, Value, Price, Gross Margin 2015-2020 Table Johnson & Johnson Profile Table Johnson & Johnson Production, Value, Price, Gross Margin 2015-2020 Table Amorepacific Profile Table Amorepacific Production, Value, Price, Gross Margin 2015-2020 Table Revlon Profile Table Revlon Production, Value, Price, Gross Margin 2015-2020 Table Kose Profile Table Kose Production, Value, Price, Gross Margin 2015-2020 Table Avon Profile Table Avon Production, Value, Price, Gross Margin 2015-2020 Table LVMH Profile Table LVMH Production, Value, Price, Gross Margin 2015-2020 Table L Brands Profile Table L Brands Production, Value, Price, Gross Margin 2015-2020 Table LOreal Profile Table LOreal Production, Value, Price, Gross Margin 2015-2020 Figure Global Cosmetic Skin Care Sales and Growth Rate (2015-2020) Figure Global Cosmetic Skin Care Revenue ($) and Growth (2015-2020) Table Global Cosmetic Skin Care Sales by Regions (2015-2020) Table Global Cosmetic Skin Care Sales Market Share by Regions (2015-2020) Table Global Cosmetic Skin Care Revenue ($) by Regions (2015-2020) Table Global Cosmetic Skin Care Revenue Market Share by Regions (2015-2020) Table Global Cosmetic Skin Care Revenue Market Share by Regions in 2015 Table Global Cosmetic Skin Care Revenue Market Share by Regions in 2019 Figure North America Cosmetic Skin Care Sales and Growth Rate (2015-2020) Figure Europe Cosmetic Skin Care Sales and Growth Rate (2015-2020) Figure Asia-Pacific Cosmetic Skin Care Sales and Growth Rate (2015-2020) Figure Middle East and Africa Cosmetic Skin Care Sales and Growth Rate (2015-2020) Figure South America Cosmetic Skin Care Sales and Growth Rate (2015-2020) Figure North America Cosmetic Skin Care Revenue ($) and Growth (2015-2020) Table North America Cosmetic Skin Care Sales by Countries (2015-2020) Table North America Cosmetic Skin Care Sales Market Share by Countries (2015-2020) Figure North America Cosmetic Skin Care Sales Market Share by Countries in 2015 Figure North America Cosmetic Skin Care Sales Market Share by Countries in 2019 Table North America Cosmetic Skin Care Revenue ($) by Countries (2015-2020) Table North America Cosmetic Skin Care Revenue Market Share by Countries (2015-2020) Figure North America Cosmetic Skin Care Revenue Market Share by Countries in 2015 Figure North America Cosmetic Skin Care Revenue Market Share by Countries in 2019 Figure United States Cosmetic Skin Care Sales and Growth Rate (2015-2020) Figure Canada Cosmetic Skin Care Sales and Growth Rate (2015-2020) Figure Mexico Cosmetic Skin Care Sales and Growth (2015-2020) Figure Europe Cosmetic Skin Care Revenue ($) Growth (2015-2020) Table Europe Cosmetic Skin Care Sales by Countries (2015-2020) Table Europe Cosmetic Skin Care Sales Market Share by Countries (2015-2020) Figure Europe Cosmetic Skin Care Sales Market Share by Countries in 2015 Figure Europe Cosmetic Skin Care Sales Market Share by Countries in 2019 Table Europe Cosmetic Skin Care Revenue ($) by Countries (2015-2020) Table Europe Cosmetic Skin Care Revenue Market Share by Countries (2015-2020) Figure Europe Cosmetic Skin Care Revenue Market Share by Countries in 2015 Figure Europe Cosmetic Skin Care Revenue Market Share by Countries in 2019 Figure Germany Cosmetic Skin Care Sales and Growth Rate (2015-2020) Figure UK Cosmetic Skin Care Sales and Growth Rate (2015-2020) Figure France Cosmetic Skin Care Sales and Growth Rate (2015-2020) Figure Italy Cosmetic Skin Care Sales and Growth Rate (2015-2020) Figure Spain Cosmetic Skin Care Sales and Growth Rate (2015-2020) Figure Russia Cosmetic Skin Care Sales and Growth Rate (2015-2020) Figure Asia-Pacific Cosmetic Skin Care Revenue ($) and Growth (2015-2020) Table Asia-Pacific Cosmetic Skin Care Sales by Countries (2015-2020) Table Asia-Pacific Cosmetic Skin Care Sales Market Share by Countries (2015-2020) Figure Asia-Pacific Cosmetic Skin Care Sales Market Share by Countries in 2015 Figure Asia-Pacific Cosmetic Skin Care Sales Market Share by Countries in 2019 Table Asia-Pacific Cosmetic Skin Care Revenue ($) by Countries (2015-2020) Table Asia-Pacific Cosmetic Skin Care Revenue Market Share by Countries (2015-2020) Figure Asia-Pacific Cosmetic Skin Care Revenue Market Share by Countries in 2015 Figure Asia-Pacific Cosmetic Skin Care Revenue Market Share by Countries in 2019 Figure China Cosmetic Skin Care Sales and Growth Rate (2015-2020) Figure Japan Cosmetic Skin Care Sales and Growth Rate (2015-2020) Figure South Korea Cosmetic Skin Care Sales and Growth Rate (2015-2020) Figure Australia Cosmetic Skin Care Sales and Growth Rate (2015-2020) Figure India Cosmetic Skin Care Sales and Growth Rate (2015-2020) Figure Southeast Asia Cosmetic Skin Care Sales and Growth Rate (2015-2020) Figure Middle East and Africa Cosmetic Skin Care Revenue ($) and Growth (2015-2020) continued

About HongChun Research: HongChun Research main aim is to assist our clients in order to give a detailed perspective on the current market trends and build long-lasting connections with our clientele. Our studies are designed to provide solid quantitative facts combined with strategic industrial insights that are acquired from proprietary sources and an in-house model.

Contact Details: Jennifer GrayManager Global Sales+ 852 8170 0792[emailprotected]

NOTE: Our report does take into account the impact of coronavirus pandemic and dedicates qualitative as well as quantitative sections of information within the report that emphasizes the impact of COVID-19.

As this pandemic is ongoing and leading to dynamic shifts in stocks and businesses worldwide, we take into account the current condition and forecast the market data taking into consideration the micro and macroeconomic factors that will be affected by the pandemic.

Cosmetic Skin Care :

HongChun Research, Cosmetic Skin Care , Cosmetic Skin Care market, Cosmetic Skin Care industry, Cosmetic Skin Care market size, Cosmetic Skin Care market share, Cosmetic Skin Care market Forecast, Cosmetic Skin Care market Outlook, Cosmetic Skin Care market projection, Cosmetic Skin Care market analysis, Cosmetic Skin Care market SWOT Analysis, Cosmetic Skin Care market insights

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Impact Of Covid-19 on Cosmetic Skin Care Market 2020 Industry Challenges, Business Overview and Forecast Research Study 2026 - PRnews Leader

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Next-gen skincare, silk without spiders and pollution for lunch: Meet the biotech startups pitching at IndieBios Demo Day – TechCrunch

By daniellenierenberg

Biotech can often, and sometimes literally, fly over our heads. However, the pandemic has shown an increased need for investment and focus on solutions that work on human and planetary health. For IndieBio, a science and biotech accelerator run by VC firm SOSV, this unprecedented year offered high stakes and new challenges.

Today and tomorrow, the biotech accelerator is hosting its twice-annual demo day.

Starting in 2015, IndieBio has provided resources to founders solving complex challenges with biotech, from fake meat to sustainability. Over the years, the accelerator has created a portfolio of biotech companies valued at over $3.2 billion, including companies like Memphis Meats, which develops cultured meat from animal cells; NotCo, a plant-based food brand; and Catalog, which uses organisms for data storage.

As part of the accelerator, each participating company receives $250,000 in capital, numerous other services and access to lab space. In July, the founder and head of IndieBio, Arvind Gupta, left his position to pursue a role at Mayfield. While Gupta remains an adviser,Po Bronson took the role as the new managing director.

Bronson was immediately put to the test. This year, the program expanded from operating solely in San Francisco to also create a cohort based in New York. It also doubled the amount of companies it invested in, bringing this cohort to 20 companies.

As you can imagine, lockdowns ultimately forced founders to delay key lab work in the beginning of the pandemic. Eventually, founders were able to partner with universities, contract research organizations or other biotech accelerators to begin their research, says Julie Wolf, the head of investor relations at SOSV. The NYC class received a golden ticket for free lab space come November.

And these dynamics make this cohort all the more fascinating to dive into.

Watch the New York Stream here, which will happen on Tuesday October 27 from 1:00-3:00pm ET.

Watch the San Francisco stream here, which will happen on Wednesday October 28 from 10:00-12:00pm PT.

For those who cant tune in, heres a list of all the companies presenting in New York and San Francisco over the next two days.

Reazent: Founded by Sumit Verma, Reazent has discovered and patented a way to manipulate soil bacteria into triggering crops to grow more. It works with 116 strains, from kale to potatoes, and wants to dig into the market of organic agricultural land.

Image Credits: Witthaya Prasongsin / Getty Images

Kraken Sense: Founded by Nisha Sarveswaran, Kraken Sense has created an in-line autonomous device to measure the concentration of pathogens in large-scale food and water systems. The product can be deployed in farms and kitchens and uses refillable single-use cartridges.

Advanced Microbubbles: The startup, led by Jameel Feshitan, has created a platform that helps practitioners deliver drugs to complex and difficult tumors. The company collaborated with NIH NIDA and uses proprietary bubbles to deliver chemotherapeutics. Currently, Microbubbles is working to solve two types of cancers: neuroblastoma and pancreatic cancer.

Cybele Microbiome:CEO Nicole Scott has created a direct-to-consumer skincare line with a focus on prebiotics. The line uses ingredients that work in tandem with the skin microbiome, even triggering it to express natural scents.

Ivy Natal:Ivy Natal is developing a process to harvest healthy human egg cells from skin cells. CEO Colin Bortner is working on a treatment for infertility and plans to enable families to have genetic children who cant otherwise with current solutions.

Microgenesis: Led by Gabriela Gutierrez, Microgenesis has created a proprietary test and nutraceutical regiment (including probiotics) to help women who struggle with infertility get pregnant. The company worked with a cohort of 287 mothers, and with its product over 75% of patients became pregnant.

Image Credits: Westend61 / Getty Images

AsimicA:Led by Nikolai Mushnikov, Asmicia has created a new way to bring stem cells to microbes. The company could lengthen and grow the yields of bio-manufacturing, and is currently working to select the right fermentation partner.

Liberum: CEO Aidan Tinafar is working to disrupt what they think could be a $400 billion market opportunity: recombinant proteins. Liberum has created a protein printer that could cut down the creation of custom recombinant proteins from weeks to a few hours.

Khepra:Led by Julie Kring, Khepra is leveraging fuel production as a way to store extra renewable energy. The company is building a series of reactors that could take your old plastic bottles and cardboard boxes, extract chemicals and fuels, and sell that fuel to refineries.

Carbix:Carbix, led by Quincy Sammy, takes enriched CO2 and converts it into raw material that can then be repurposed into industrial products.

Spintex: CEO Alex Greenhalgh is creating a new, scalable way of making silk. The company mimics spider spinning and uses a natural protein, with an end product that they see as better than premium silk.

Biomage:CEO Adam Kurkiewicz wants to make single-cell sequencing data more accessible for research biologistics. The technology could help scientists explore human cells to enhance medicine and drug discovery.

Diptera.ai: Vic Levitin is creating a scalable, affordable and sustainable way to fight mosquitoes and their diseases.

Cayuga Biotech:Damien Kudela, CEO of Cayuga Biotech, has created a drug that could induce clots and stop severe bleeding situations.

Brightcure:Chiara Heide, CEO of Brightcure, has created a bioactive cream that uses natural bacterium to restore a womans natural microbiome.

Multus Media:CEO Cai Linton is producing an ingredient that hopes to make cultivated meat production affordable and accessible.

Image Credits: Getty Images

BioFeyn:The company uses nanotechnologies based on human medicine to deliver nutrients and disease prevention to fish. CEO Timothy Bouley is working to make eating healthy fish a sustainable practice.

Halomine: Ted Eveleth, CEO, wants to turn every surface into an antimicrobial surface. Halomines product, Halofilm, can be used in tandem with any household bleach cleaner to enhance disinfection techniques.

Allied Microbiota:Lauralynn Kourtz, CEO of Allied Microbiota, wants to use natural microbes to eliminate toxic waste. The company uses bacteria to clean contaminated soils.

Scindo: Scindo, led by Gustaf Hemberg, uses enzymes to make plastic biodegradable.

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Role of Trop-2 as an Actionable Biomarker in Solid Tumors – OncLive

By daniellenierenberg

Trophoblast cell surface antigen 2 (Trop-2) is a glycoprotein that spans the epithelial membrane surface and plays a role in cell self-renewal, proliferation, and transformation.1,2 Encoded by the TACSTD2 gene, Trop-2 is a 35-kDa protein composed of a large extracellular domain, a single transmembrane domain, and a short intracellular tail that is the functionally dominant part of the protein.1-4

Under physiological conditions, Trop-2 plays an essential role in embryonic development, placental tissue formation, embryo implantation, stem cell proliferation, and organ development.2 A low basal expression level of Trop-2 is found on the surface of multiple normal epithelial tissues, including skin and oral mucosa.1,3 Trop-2 can promote tumor growth and its overexpression is common in many types of malignant epithelial tumors.1,2,4

Expression of Trop-2 is regulated by several pro-oncogenic transcription factors (eg, CREB1, nuclear factor [NF]B, and HOXA10) via positive feedback relationships.2 Trop-2 expression may be upregulated because of the inactivation of several transcription factors (eg, HNF4A, TP63/TP53L, ERG, HNF1A/TCF-1, and FOXP3).1,2 Overexpression of Trop-2 accelerates the cancer cell cycle and drives cancer growth. Knocking out the TACSTD2 gene disturbs the proliferation of tumor cells, further validating the role of Trop-2 in tumorigenesis.1

Trop-2 was first elucidated as a transducer of intracellular calcium signals; however, it is now known to function in a variety of cell signaling pathways associated with tumorigenesis (Figure 1).1,2,4 Expression of Trop-2, as a calcium signal transducer, causes calcium to be mobilized from internal stores. Increased intracellular calcium levels activate MAPK, which in turn increases levels of phosphorylated ERK1 and ERK2.2,4 ERK1 and ERK2 are important mediators of cell cycle progression, angiogenesis, cell proliferation, cell invasion, and metastasis.2,4 Intracellular calcium also activates the NF-B pathway, which is involved in stimulation of cell growth, and the RAF pathway, which is essential for the upregulation of FOXM1, one of the most commonly overexpressed genes in human solid tumors.2

In addition to stimulating calcium release and MAPK signaling, Trop-2 is involved in several other pro-oncogenic signaling pathways, leading to tumor cell growth and proliferation. Activation of cyclin E and D further promotes cell cycle progression.4Alteration of the Notch, Hedgehog, and Wnt pathways may discourage appropriate stem cell proliferation and differentiation.2,4 Trop-2 signaling also appears to be dependent on -catenin.5 Direct interaction between -catenin and the intracellular domain of Trop-2, through -catenin signaling, enhances stem celllike properties (eg, self-renewal and transformation) of cancer cells.5 Attenuation of IGF-1 receptor signaling by Trop-2 encourages cancer growth and malignancy, particularly in lung cancers.2

Trop-2 is inextricably linked to cancer progression and metastasis because of its role as a key regulator of the hallmarks of cancer, including cell growth, proliferation, migration, invasion, and survival.4 A variety of human epithelial cancer cells are characterized by Trop-2 overexpression, including breast, lung, urothelial, gastric, colorectal, pancreatic, prostatic, cervical, head and neck, and ovarian carcinomas.2,3 In an analysis of 702 tissue samples from patients with breast cancer, Trop-2 expression was detected via immunohistochemistry (IHC) across a wide range of breast cancer subtypes.6 Trop-2 expression is substantially higher in hormone receptorpositive/HER2-negative (HR+/HER2-) disease and triple-negative breast cancer (TNBC) compared with other breast cancer subtypes, including HER2-positive disease.7

Trop-2 overexpression is also common in nonsmall cell lung cancer (NSCLC).8 Using IHC on tissues collected from the tumors of 68 patients with NSCLC, Trop-2 expression was significantly higher in NSCLC tissues compared with matched healthy tissues (P < .05). Moreover, its overexpression was associated with worse tumor, node, metastasis stage (P = .012), lymph node metastasis (P = .038), and histologic grade (P = .013).9

Bladder cancer, the most common urothelial cancer, is also marked by elevated Trop-2 expression.10,11 In a study of 102 transitional cell bladder cancer samples, IHC staining for Trop-2 demonstrated increased Trop-2 expression compared with noncancerous samples, and this expression pattern was significantly associated with worsened tumor grade (P = .001), stage (P < .0 01), and bladder cancer recurrence (P = .0 3).11

Molecular markers that influence the biological progress of tumors often serve as important prognostic indicators. Overexpression of Trop-2 has been associated with more aggressive disease, poorer overall survival (OS), and worse disease-free survival in patients with solid tumors.4 A meta-analysis conducted in 2016 explored the association of Trop-2 expression and prognosis in patients with a variety of solid tumors (N = 2569). Results from the study showed that high Trop-2 expression negatively affected OS (hazard ratio, 1.896; 95% CI, 1.599-2.247; P < .001) and disease-free survival (pooled hazard ratio, 2.336; 95% CI, 1.596-3.419; P < .0 01).12

Specific to breast cancers, increased Trop-2 mRNA is a strong predictor of lymph node involvement, distant metastasis, and poor OS.13,14 Trop-2 is expressed across all breast cancer subtypes; however, overexpression appears more common in aggressive disease subtypes, including HR+/HER2- disease and TNBC.7

Trop-2 overexpression is also associated with poor outcomes in patients with urothelial cancer. In an analysis of 102 tissue samples collected from patients with noninvasive bladder cancer, Trop-2 expression was higher in samples from patients who experienced disease recurrence compared with those who did not have recurrent disease (P = .0 3). Additionally, patients with Trop-2 overexpression had significantly lower rates of recurrence-free survival (P = .0 01).11 In a separate study, high Trop-2 expression analyzed by IHC was strongly correlated with bladder cancer severity and worsened disease prognosis, with particularly strong Trop-2 expression in muscle-invasive bladder cancer tissues compared with normal bladder tissues (P < .0 01).15

Taken together, the data indicate that Trop-2 is a potentially valuable therapeutic target, given the connection between its overexpression and poor prognosis in various solid tumors.4,15 Its value as a prognostic indicator and potential target for therapeutic development is particularly evident in advanced cancers that have limited or few treatment options available, such as TNBC and metastatic urothelial cancers.

Metastatic TNBC

TNBC is an aggressive form of invasive breast cancer that accounts for 15% to 20% of all breast cancers and a disproportionate number of deaths due to breast cancer.16-18 Its prevalence is particularly high in premenopausal women and those of African American and Hispanic descents.17,19 TNBC is characterized by a lack of estrogen and progesterone receptors and a low expression of HER2; therefore, TNBC cannot be effectively treated with standard hormone-based therapies and HER2-targeted agents.16, 20Although chemotherapy has shown promising results in early TNBC, the majority of patients relapse and progress to metastatic TNBC within the first 3 to 5 years after initial treatment.18 The treatment of metastatic TNBC remains a clinical challenge, as no standard-of-care chemotherapy exists for previously treated patients.17,18 There is an urgent unmet need for effective treatment options in patients with metastatic TNBC.18

Metastatic Urothelial Cancer

In the United States, an estimated 81,400 new cases of urothelial cancer will be diagnosed in 2020, and approximately 18,000 Americans will die from the disease.21 The majority of urothelial cancers arise in the bladder, and established risk factors for bladder cancer include older age, male gender, Caucasian race, family history, and smoking.22,23 Muscle-invasive and meta-static urothelial cancers represent 25% of urothelial carcinoma cases and are characterized by substantially worse prognostic outcomes.23,24 Current chemotherapeutic options for metastatic disease offer a modest median OS of 15 months and a 5-year survival of less than 5%.23,24 Long-term survival is infrequent, and newer treatment modalities that target distinct molecular biomarkers are warranted.24,25

As Trop-2 is a clinically relevant cell surface antigen among several solid tumor types, its overexpression on cancer cells makes it an ideal candidate for targeting by specific therapies.26 One targeted approach involves the use of antibody-drug conjugates (ADCs), a technology that has revolutionized the approach to cancer chemo-therapy over the past 2 decades.26

An ADC is designed to contain 3 components: a monoclonal antibody (mAb), a cytotoxic drug called a payload, and a linker that connects the mAb to the cytotoxin. The mAb binds specifically to its tumor-associated antigen (eg, Trop-2), thereby delivering the cytotoxin to the surface of the tumor cell. Once bound, the ADC is internalized through receptor-mediated endocytosis. Lysosomal degradation of the ADC ensues, facilitating the release of the cytotoxin and enabling it to bind to its intracellular target and induce apoptotic cell death (Figure 2).26,27 The targeted nature of ADCs allows potent therapy to be delivered to the cancer cell itself, limiting systemic exposure. The result is fewer adverse effects (AEs), a wider therapeutic window, and reduced exposure of the drug to efflux mechanisms that can increase drug resistance.26,27

Sacituzumab govitecan-hziy is the only FDA-approved Trop-2targeted ADC, and several other agents are under preclinical and clinical development.28

Sacituzumab govitecan-hziy is an ADC that binds to Trop-2 and delivers a potent cytotoxic drug into tumor cells.29,30 The FDA recently granted it accelerated approval for the treatment of metastatic TNBC, and it has also received fast track designation for metastatic urothelial carcinoma, NSCLC, and small cell lung cancer.28,30-32

The composition of sacituzumab govitecan-hziy has been optimized to effectively target tumors expressing Trop-2. A humanized monoclonal antibody (hRS7) binds to Trop-2 and delivers govitecan (SN-38) to the cell surface. SN-38 is the active metabolite of irinotecan and functions as a DNA topoisomerase I inhibitor. A hydrolysable CL2a linker covalently binds SN-38 to h R S 7.30 When released intracellularly, SN-38 causes double-stranded DNA breaks that lead to apoptosis.29 Additionally, the hydrolysable linker allows a portion of the SN-38 payload to be released into the tumor microenvironment, leading adjacent tumor cells to be killed via a bystander effect.31,32

Sacituzumab govitecan-hziy delivers SN-38 in its most active nonglucuronidated form. Because of its moderate toxicity profile, SN-38 is conjugated to hRS7 at a high drug-to-antibody ratio of up to 8 SN-38 molecules per antibody, allowing for greater drug delivery than systemic irinotecan can achieve.29,32 Irinotecan causes grade 3 to 4 diarrhea in approximately one-third of patients, whereas the lower toxicity of SN-38 may confer an improved therapeutic index.29,30 This high level of drug delivery may overcome the ability of Trop-2expressing tumors to repair DNA breaks.30

On April 22, 2020, sacituzumab govitecan-hziy received accelerated approval from the FDA for the treatment of adult patients with metastatic TNBC who have received at least 2 prior therapies for metastatic disease.28 Approval was based on findings of the phase 1/2, single-arm, multicenter IM-T-IMMU-132-01 trial (NCT01631552), in which sacituzumab govitecan-hziy produced durable responses in a subset of patients with heavily pretreated metastatic TNBC.31,33

The IM-T-IMMU-132-01 trial enrolled 108 patients with metastatic TNBC who had received at least 2 prior treatments for metastatic disease. In the study population, the median number of prior systemic therapies in the metastatic setting was 3, and the majority of patients received prior taxanes (98%) and anthracyclines (86%) in the neoadjuvant or metastatic setting. The median age of study patients was 55 years (range 31-80); 99% were female, and 76% were Caucasian.31Brain metastases were present in 23% of patients, and visceral metastases were present in 77% of patients; these included metastases in the lung/pleura (57%), the liver (42%), and other visceral organs (adrenal glands, pancreas, and kidney; 7%).31

Patients received sacituzumab govitecan-hziy 10 mg/kg administered intravenously on days 1 and 8 of 21-day cycles. Treatment continued until disease progression or unacceptable toxicity. The primary efficacy end point was objective response rate (ORR) assessed according to RECIST 1.1 tumor criteria. The secondary efficacy end points included time to response, duration of response, clinical benefit rate (defined as a complete or partial response or stable disease for 6 months), progression-free survival (PFS), and OS.31

After a median follow-up duration of 9.7 months, an objective response occurred in 36 of 108 patients (ORR, 33.3%; 95% CI, 24.6%-43.1%), including a complete response in 3 patients.31 The median time to response was 2 months (range 1.6-13.5). The median response duration was 7.7 months (95% CI, 4.9-10.8), with 55.6% of patients responding at 6 months and 16.7% of patients still responding at 12 months.31,34 An independent central review of the data found a similar ORR and median response duration (34.3% and 9.1 months, respectively).31 The clinical benefit rate, including stable disease for at least 6 months, was 45.4%. Median PFS was 5.5 months; the estimated probability of PFS at 6 and 12 months was 41.9% and 15.1%, respectively. Median OS was 13 months (95% CI, 11.2-13.7); the estimated probability of survival at 6 and 12 months was 78.5% and 51.3%, respectively.31

The most common AEs of any grade were nausea (67%), neutropenia (64%), diarrhea (62%, predominantly grade 1), and fatigue (55%). Of grade 3 or 4 AEs, the most common were neutropenia, decreased white cell count, and anemia (occurring in 42%, 11%, and 11% of patients, respectively).31 Serious AEs occurred in 32% of patients, with the most common being febrile neutropenia (7%), vomiting (6%), nausea (4%), diarrhea (3%), and dyspnea (3%). Occurrence of AEs led to treatment interruption in 44% of patients, dose reductions in 34%, and discontinuation of treatment in 3%.31,34

IM-T-IMMU-132-01 Trial HR+/HER2- Subpopulation Analysis

Treatment with sacituzumab govitecan-hziy showed encouraging results in a prespecified subpopulation of patients with histologically confirmed HR+/HER2- metastatic breast cancer from the IM-T-IMMU-132-01 trial.32

A total of 54 patients with histologically confirmed HR+/HER2- metastatic breast cancer were enrolled. Eligible patients had received at least 1 line of hormone-based therapy and at least 1 prior chemotherapy in the metastatic setting. The median age of enrollees was 54 years (range, 33-79); aside from required prior hormone-based therapy, previous chemotherapies included a taxane (85%), an anthracycline (67%), capecitabine (65%), a CDK4/6 inhibitor (61%), an mTOR inhibitor (44%), and an immune checkpoint inhibitor (1.9%). After a washout period of at least 2 weeks since prior treatment, sacituzumab govitecan-hziy was dosed at 10 mg/kg via intravenous infusion on days 1 and 8 of 21-day cycles.32

The primary efficacy end point was ORR. Of the 54 patients enrolled, 17 patients achieved partial responses during a median follow-up duration of 11.5 months (ORR, 31.5%; 95% CI, 19.5%-45.6%). In the key secondary outcomes, patients experienced a median PFS of 5.5 months (95% CI, 3.6-7.6) and a median OS of 12.0 months (95% CI, 9.0-18.2). The median time to response was 2.1 months (95% CI, 1.4-7.8), and median duration of response was 8.7 months (95% CI, 3.7-12.7). Of the 17 responders, 4 achieved a response lasting more than 12 months (24%). The clinical benefit rate was 44.4% (95% CI, 30.9%-58.6%), with 7 patients showing stable disease for at least 6 months.32

Safety analyses showed a manageable AE profile for sacituzumab govitecan-hziy. There were no reports of cardiac toxicity or severe peripheral neuropathy. The most common grade 3 or higher treatment-related AE was neutropenia, which occurred in 50% of patients. The incidence of diarrhea was 46% and was mild overall. Grade 3 diarrhea was reported in 4 patients, with no reports of grade 4.32 Serious AEs occurred in 2 patients, who experienced febrile neutropenia and 1 case each of neutropenia, viral pneumonia, sepsis, diarrhea, nausea, vomiting, dehydration, and acute respiratory failure.32

ESMO 2020 Data: ASCENTTrial in Metastatic TNBC (NCT02574455)

Final results of the international, multicenter, open-label ASCENT trial (NCT02574455) were presented at the European Society for Medical Oncology (ESMO) Virtual Congress 2020. ASCENT was the first phase 3 study of an ADC to show improvement in PFS and OS compared with standard-of-care chemotherapy in patients with previously treated metastatic TNBC.35,36

A total of 529 patients with metastatic TNBC were randomized 1:1 to receive either sacituzumab govitecan-hziy or physicians choice of single-agent chemotherapy (capecitabine, eribulin, vinorelbine, or gemcitabine). The dose of sacituzumab govitecan-hziy was 10 mg/kg intravenously on days 1 and 8 of 21-day cycles. All patients had histologically or cytologically confirmed TNBC refractory to or relapsed after at least 2 prior chemotherapies including a taxane. The median age of the study population was 54 years, and the median number of prior chemotherapies received was 4.

In the primary end point, sacituzumab govitecan-hziy significantly improved median PFS (hazard ratio, 0.41; P< .0001) compared with chemotherapy. The sacituzumab govitecan-hziy treatment group achieved a median PFS of 5.6 months compared with 1.7 months in the chemotherapy treatment group. Compared with chemotherapy, sacituzumab govitecan-hziy treatment also significantly improved key secondary end points of OS (12.1 vs 6.7 months; hazard ratio, 0.48; P < .0001) and ORR (35% vs 5%; P < .0001).35,36

The most common treatment-related grade 3 or higher AEs with sacituzumab govitecan-hziy compared with chemotherapy were neutropenia (51% vs 33%, respectively), diarrhea (10.5% vs < 1.0%), anemia (8% vs 5%), and febrile neutropenia (6% vs 2%). No treatment-related deaths were reported, and no cases of neuropathy or interstitial lung disease greater than grade 3 occurred with sacituzumab govitecan-hziy.35

ESMO 2020 Data: Sacituzumab Govitecan-hziy in Combination with Talazoparib for Patients with Metastatic TNBC (NCT04039230)

At the ESMO Virtual Congress 2020, investigators presented the trial design, objectives, and status of a phase 1/2, open-label study that will investigate the efficacy and safety of sacituzumab govitecan-hziy in combination with the PARP inhibitor talazoparib for patients with metastatic TNBC.37 PARP is involved in repairing damaged DNA and is required for clearance of Trop-2 cleavage complexes; thus, PARP inhibitors may be complementary therapeutic partners with sacituzumab govitecan-hziy.37, 38

This study will include a dose escalation in phase 1b followed by a dose expansion in phase 2. Patients will receive sacituzumab govitecan-hziy on days 1 and 8 of 21-day cycles and talazoparib daily on days 15 to 21 of each cycle.38 The primary objective of phase 1b is to assess the dose-limiting toxicity rate and maximum tolerated dose of sacituzumab govitecan-hziy when given in combination with talazoparib. From these data, investigators will determine the recommended phase 2 dose. During phase 2, investigators will assess the ORR, PFS, OS, and clinical benefit rate. As of August 30, 2020, the trial was undergoing active recruitment, and a total of 20 patients were enrolled.37, 38

ESMO 2020 Data: Sacituzumab Govitecan-hziy for Breast Cancer Brain Metastases (NCT03995706)

SN-38, the cytotoxic payload delivered by sacituzumab govitecan-hziy, crosses the blood-brain barrier and is often included in central nervous system (CNS) cancer regimens.39 Investigators hypothesized that sacituzumab govitecan-hziy would yield therapeutically relevant SN-38 concentrations within the CNS of patients under-going craniotomy for breast cancer brain metastases or recurrent glioblastoma.39,40

In this single-center, nonrandomized, phase 0 study (NCT03995706), patients receive a single 10-mg/kg intravenous dose of sacituzumab govitecan-hziy the day prior to craniotomy and then resume therapy (on days 1 and 8 of 21-day cycles) after recovery. To date, 14 patients have been treated. For patients with recurrent glioblastoma (n = 7), the mean SN-38 concentration was 420 nM; for patients with breast cancer brain metastases (n = 7), the mean SN-38 concentration was 626 nM. Among those patients with residual measurable disease, 2 partial intracranial responses have been observed in each group after 12 weeks of treatment (ORR, 28% and 50% for glioblastoma and breast cancer brain metastases, respectively). As of September 2020, recruitment for this trial was ongoing.39,40

The metastatic urothelial cancer cohort of the IM-T-IMMU-132-01 trial reported encouraging activity with sacituzumab govitecan-hziy monotherapy (ORR, 31%; median PFS, 7.3 months; and median OS, 18.9 months).41Sacituzumab govitecan-hziy has FDA fast track desig-nation for metastatic urothelial cancer and is currently under further investigation in the phase 2 TROPHY U-01 trial (NCT03547973) and the upcoming phase 3 TROPiCS-04 trial (NCT04527991).42-45

Final data for cohort 1 and the trial design for cohort 3 were presented at the ESMO Virtual Congress 2020 for the pivotal phase 2, open-label, multicohort TROPHY U-01trial. The TROPHY U-01trial is investigating the safety and efficacy of sacituzumab govitecan-hziy in patients with heavily pretreated metastatic urothelial cancer across several cohorts. The study population across the TROPHY U-01 trial includes patients with disease progression despite treatment with platinum (PLT)-based chemotherapy, checkpoint inhibitors, or both. For all cohorts, the primary efficacy end point is ORR, and key secondary end points include PFS, OS, duration of response, and safety analyses.44,45

Cohort 1

Cohort 1 included a total of 113 patients who were treated with sacituzumab govitecan-hziy. The study population included patients who experienced disease progression after both PLT-based chemotherapy and checkpoint inhibitor therapy.44 Overall, patients in cohort 1 were previously treated with a median of 3 therapies and were a median of 66 years of age. In the results presented at ESMO 2020, a total of 31 patients had achieved an objective response (ORR, 27%; 95% CI, 19%-37%), of which 6 were complete responses and 25 were partial responses. The median duration of response was 5.9 months (95% CI, 4.7-8.6); median PFS and OS were 5.4 months (95% CI, 3.5-6.9) and 10.5 months (95% CI, 8.2-12.3), respectively. Sacituzumab govitecan-hziy demonstrated manageable toxicity. Key grade 3 or higher AEs were neutropenia (35%), anemia (14%), febrile neutropenia (10%), and diarrhea (10%).44

Cohort 3

As of March 2020, cohort 3 had started enrollment and is ongoing. The study plans to enroll a total of 61 patients with metastatic urothelial cancer who are nave to checkpoint inhibitor agents and have experienced disease progression or recurrence after PLT-based chemotherapy.45 As checkpoint inhibitors are the stan-dard-of-care therapy for patients who have failed on PLT-based chemotherapy, this study will investigate combination therapy with sacituzumab govitecan-hziy and the checkpoint inhibitor pembrolizumab. Exclusion criteria include active autoimmune disease or a history of interstitial lung disease, given the coadministration of pembrolizumab. A 10-patient lead-in cohort will determine standard the recommended phase 2 dose of sacituzumab govitecan-hziy (given on days 1 and 8 of 21-day cycles), to be given along with pembrolizumab 200 mg on day 1 of each cycle. The primary end point of ORR and secondary end points of PFS, OS, clinical benefit rate, duration of response, and safety will be assessed.45

The phase 3, global, open-label TROPiCS-04trial aims to enroll 482 patients to investigate the efficacy and safety of sacituzumab govitecan-hziy in patients with metastatic or locally advanced unresectable urothelial cancer who have progressed despite prior therapy with PLT-based chemotherapy and a PD-1 or PD-L1 checkpoint inhibitor. Sacituzumab govitecan-hziy will be compared with physicians choice of chemotherapy (paclitaxel, docetaxel, or vinflunine). The primary outcome measure will be OS; secondary outcomes will include PFS, ORR, safety, and quality of life. As of August 2020, the trial was not yet recruiting patients.43

Evaluation of novel and existing ADCs has revealed that success is not based on the use of any one particular cytotoxic compound or conjugate platform. Factors such as the consistency and level of target-antigen expression, tumor progression, and specific properties of the cancer and stage of disease also play important roles.46 Several additional Trop-2targeted ADCs are currently being investigated in solid tumors (Table).33,36,37,40,42,43,47-51

DS-1062a is a Trop-2directed ADC that contains the cytotoxic compound DXd, a derivative of exatecan that acts as a DNA topoisomerase I inhibitor.52 It is currently being investigated for the treatment of advanced NSCLC in an ongoing phase 1, multicenter, open-label study (NC T 03 401385).48

The study involves a dose-escalation phase and a dose-expansion phase. Dose-limiting toxicity, maximum tolerated dose, and AEs will be explored in both phases.47 Eligible patients have experienced disease progression or recurrence despite previous treatments, have measurable disease per RECIST 1.1 criteria, and are able to provide a sufficient tumor tissue sample for Trop-2 measurement. Patients with multiple primary malignancies or untreated brain metastases are ineligible for the study.48

As of November 2018, a total of 22 patients had been treated with 1 of 3 escalating doses of DS-1062a. Nearly 82% of patients experienced at least 1 treatment-emergent AE, with fatigue being the most common complaint. Fatigue was the only reported grade 3 or higher AE and was reported by 1 patient. Of 18 tumor-evaluable patients, 1 showed a partial response and 8 showed stable disease. Maximum-tolerated dose has not been achieved, and investigators will continue to monitor for safety and disease progression.47, 48

RN927C

RN927C, also known as PF-06664178, is an ADC composed of a Trop-2directed antibody conjugated with the cytotoxic microtubule inhibitor PF-06380101. Release of PF-06380101 leads to mitotic arrest, apoptosis, and cell death.3 Preclinical studies demonstrated the ability of RN927C to induce cell death among various tumor cell lines, including those from the skin, lung, head and neck, breast, ovary, and colon.3

RN927C was investigated in a phase 1, open-label, nonrandomized dose-escalation study (NCT02122146)of patients with advanced or metastatic solid tumors that were unresponsive to current therapies or for whom no standard therapy was available. The primary objective of the study was to determine the maximum tolerated dose and recommended phase 2 dose. Secondary outcomes included safety and preliminary evidence of antitumor activity. A total of 31 patients were enrolled and received treatment with escalating doses of RN927C. Stable disease was noted in 11 patients (39%), but no partial or complete responses were seen. Doses of 3.6 mg/kg, 4.2 mg/kg, and 4.8 mg/kg were considered intolerable, primarily because of skin reactions and development of neutropenia. The next-lower dose of 2.4 mg/kg was well tolerated, but the study was terminated early because of minimal anti-tumor activity and excessive toxicities.50

BAT8003

BAT8003 is an ADC composed of a Trop-2directed antibody conjugated to a potent cytotoxic maytansine derivative. The ADC has been optimized to facilitate site-specific conjugation, which allows for a more controllable drug-antibody ratio. In addition, a fucosylation of the Fc region of the antibody enhances its antibody-dependent cell-mediated cytotoxicity effect. In preclinical xenograft and primate models, BAT8003 demonstrated strong inhibition of tumor growth at doses of 5 mg/kg and 15 mg/kg, with a highest nonseverely toxic dose of 20 mg/kg given once every 3 weeks.51, 53

Given the promising preclinical data, a phase 1 dose-escalation study (NCT03884517) is currently investigating the safety, tolerability, and pharmacokinetics of BAT8003 in patients with advanced epithelial cancer who are either ineligible for standard therapy or have disease refractory to standard therapy.Eligible patients will receive escalating doses of BAT8003 (0.2-10.0 mg/kg) on day 1 of each 21-day cycle. The study will be divided into 3 periods: (1) the first 21-day cycle, which will examine the safety of a single BAT8003 administration, observe for dose-limiting toxicities, and establish preliminary pharmacokinetic parameters; (2) cycles 2 through 8, which will examine safety, immunogenicity, and preliminary efficacy of escalating doses of BAT8003; and (3) an expansion period, which could include an additional 10 to 30 cases to further assess safety and efficacy once a safe and effective dose has been established. As of the last update on March 21, 2019, the trial was actively recruiting patients.51

Trop-2 has established itself as a clinically meaningful biomarker among several types of solid malignancies. Its ability to promote self-renewal, proliferation, and cell invasion makes it an ideal candidate for targeted anti-tumor therapies, including ADCs.

Sacituzumab govitecan-hziy is the first Trop-2directed ADC to receive FDA approval for the treatment of metastatic TNBC. In the pivotal IM-T-IMMU-132-01 trial, sacituzumab govitecan-hziy showed encouraging results in patients with multiple difficult-to-treat solid tumor types, including TNBC, HR+/HER2- metastatic breast cancer, and metastatic urothelial cancer.31,32,41 Sacituzumab govitecan-hziy and other Trop-2directed ADCs represent a novel strategy to improve outcomes among these populations of patients with few therapeutic options. Data from additional trials of sacituzumab govitecan-hziy were presented at the ESMO Virtual Congress 2020. In the ASCENT trial, sacituzumab govitecan improved response rates and survival outcomes in patients with metastatic TNBC compared with standard-of-care therapy.35 Data from a cohort of patients with metastatic urothelial cancer in the TROPHY U-01 trial indicated positive survival impacts with manageable toxicity.44 Additional trials of sacituzumab-govitecan-hziy (as monotherapy or in combination with PARP inhibitors or checkpoint inhibitors) are under way in patients with metastatic TNBC, breast cancer brain metastases, and metastatic or locally advanced urothelial cancer.37,40,43,45 Other Trop-2directed ADCs are under investigation in NSCLC and advanced epithelial cancers.47, 51

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Role of Trop-2 as an Actionable Biomarker in Solid Tumors - OncLive

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The Stem Cell-Derived Cells market to be in conjunction to growth from 2020 to 2030 – PRnews Leader

By daniellenierenberg

Stem cell-derived cells are ready-made human induced pluripotent stem cells (iPS) and iPS-derived cell lines that are extracted ethically and have been characterized as per highest industry standards. Stem cell-derived cells iPS cells are derived from the skin fibroblasts from variety of healthy human donors of varying age and gender. These stem cell-derived cells are then commercialized for use with the consent obtained from cell donors. These stem cell-derived cells are then developed using a complete culture system that is an easy-to-use system used for defined iPS-derived cell expansion. Majority of the key players in stem cell-derived cells market are focused on generating high-end quality cardiomyocytes as well as hepatocytes that enables end use facilities to easily obtain ready-made iPSC-derived cells. As the stem cell-derived cells market registers a robust growth due to rapid adoption in stem cellderived cells therapy products, there is a relative need for regulatory guidelines that need to be maintained to assist designing of scientifically comprehensive preclinical studies. The stem cell-derived cells obtained from human induced pluripotent stem cells (iPS) are initially dissociated into a single-cell suspension and later frozen in vials. The commercially available stem cell-derived cell kits contain a vial of stem cell-derived cells, a bottle of thawing base and culture base.

The increasing approval for new stem cell-derived cells by the FDA across the globe is projected to propel stem cell-derived cells market revenue growth over the forecast years. With low entry barriers, a rise in number of companies has been registered that specializes in offering high end quality human tissue for research purpose to obtain human induced pluripotent stem cells (iPS) derived cells. The increase in product commercialization activities for stem cell-derived cells by leading manufacturers such as Takara Bio Inc. With the increasing rise in development of stem cell based therapies, the number of stem cell-derived cells under development or due for FDA approval is anticipated to increase, thereby estimating to be the most prominent factor driving the growth of stem cell-derived cells market. However, high costs associated with the development of stem cell-derived cells using complete culture systems is restraining the revenue growth in stem cell-derived cells market.

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The global Stem cell-derived cells market is segmented on basis of product type, material type, application type, end user and geographic region:

Segmentation by Product Type

Segmentation by End User

The stem cell-derived cells market is categorized based on product type and end user. Based on product type, the stem cell-derived cells are classified into two major types stem cell-derived cell kits and accessories. Among these stem cell-derived cell kits, stem cell-derived hepatocytes kits are the most preferred stem cell-derived cells product type. On the basis of product type, stem cell-derived cardiomyocytes kits segment is projected to expand its growth at a significant CAGR over the forecast years on the account of more demand from the end use segments. However, the stem cell-derived definitive endoderm cell kits segment is projected to remain the second most lucrative revenue share segment in stem cell-derived cells market. Biotechnology and pharmaceutical companies followed by research and academic institutions is expected to register substantial revenue growth rate during the forecast period.

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North America and Europe cumulatively are projected to remain most lucrative regions and register significant market revenue share in global stem cell-derived cells market due to the increased patient pool in the regions with increasing adoption for stem cell based therapies. The launch of new stem cell-derived cells kits and accessories on FDA approval for the U.S. market allows North America to capture significant revenue share in stem cell-derived cells market. Asian countries due to strong funding in research and development are entirely focused on production of stem cell-derived cells thereby aiding South Asian and East Asian countries to grow at a robust CAGR over the forecast period.

Some of the major key manufacturers involved in global stem cell-derived cells market are Takara Bio Inc., Viacyte, Inc. and others.

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The Stem Cell-Derived Cells market to be in conjunction to growth from 2020 to 2030 - PRnews Leader

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Zenith Confirms Interim Filings on SEDAR

By Dr. Matthew Watson

CALGARY, Alberta, Oct. 28, 2020 (GLOBE NEWSWIRE) -- Zenith Capital Corp. (“Zenith” or the “Company”) today announces that, further to its October 9, 2020 press release, it today has filed its interim financial statements and related MD&A for the three months ended July 31, 2020 (the “Interim Filings”). These filings can be found at www.sedar.com under the Company’s profile.

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Zenith Confirms Interim Filings on SEDAR

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Tauriga Sciences, Inc. Updates Shareholders on New York State’s Determination to Allow the Sale of CBD Edibles in the Forms of Food & Drink

By Dr. Matthew Watson

The Company’s Flagship Brand Tauri-Gum™ is Fully Compliant With the New Rules Set Out This Week by New York State (“New York”)

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Tauriga Sciences, Inc. Updates Shareholders on New York State's Determination to Allow the Sale of CBD Edibles in the Forms of Food & Drink

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XORTX Participation in Virtual Conferences

By Dr. Matthew Watson

CALGARY, Alberta, Oct. 28, 2020 (GLOBE NEWSWIRE) -- XORTX Therapeutics Inc. ("XORTX" or the “Company”) (CSE: XRX) (OTCQB: XRTXF), a biopharmaceutical company focused on developing innovative therapies to treat progressive kidney disease, is pleased to announce its participation in two upcoming virtual conferences in November 2020.

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GenMark Diagnostics Reports Third Quarter 2020 Results

By Dr. Matthew Watson

CARLSBAD, Calif., Oct. 28, 2020 (GLOBE NEWSWIRE) -- GenMark Diagnostics, Inc. (Nasdaq: GNMK), a leading provider of automated, multiplex molecular diagnostic testing systems, today announced financial results for the quarter ended September 30, 2020.

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GenMark Diagnostics Reports Third Quarter 2020 Results

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Alimera Sciences Announces Third Quarter 2020 Financial Results

By Dr. Matthew Watson

Rebound Continues from COVID Challenges Rebound Continues from COVID Challenges

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Alimera Sciences Announces Third Quarter 2020 Financial Results

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Acura Pharmaceuticals and AD Pharma Amend License to LIMITx™ LTX-03

By Dr. Matthew Watson

Amendment Extends NDA Acceptance Date and Expands Agreement Amendment Extends NDA Acceptance Date and Expands Agreement

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Histogen to Report Third Quarter 2020 Earnings on November 12, 2020

By Dr. Matthew Watson

SAN DIEGO, Oct. 28, 2020 (GLOBE NEWSWIRE) -- Histogen Inc. (NASDAQ: HSTO), a clinical-stage therapeutics company focused on developing potential first-in-class restorative therapeutics that ignite the body’s natural process to repair and maintain healthy biological function, today announced that Histogen’s financial results for the third quarter ended September 30, 2020 will be released after the close of market on Thursday, November 12, 2020.

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Histogen to Report Third Quarter 2020 Earnings on November 12, 2020

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MacroGenics Announces Date of Third Quarter 2020 Financial Results Conference Call

By Dr. Matthew Watson

ROCKVILLE, MD, Oct. 28, 2020 (GLOBE NEWSWIRE) --  MacroGenics, Inc. (NASDAQ: MGNX), a clinical-stage biopharmaceutical company focused on discovering and developing innovative monoclonal antibody-based therapeutics for the treatment of cancer, today announced that the Company will release its financial results for the third quarter of 2020 after the market closes on Wednesday, November 4, 2020. MacroGenics will host a conference call to discuss the financial results and recent corporate progress on Wednesday, November 4, 2020 at 4:30 p.m. ET. The conference call can be accessed by dialing (877) 303-6253 (domestic) or (973) 409-9610 (international) five minutes prior to the start of the call and providing the Conference ID 5986584.

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Inventiva to host a Key Opinion Leader webcast from the AASLD The Liver Meeting Digital Experience™ 2020

By Dr. Matthew Watson

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Inventiva to host a Key Opinion Leader webcast from the AASLD The Liver Meeting Digital Experience™ 2020

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Syneos Health to Acquire Synteract, a Top CRO Provider to Emerging Biopharma

By Dr. Matthew Watson

Combination Enhances Syneos Health’s Industry-Leading Position Across Fast-Growing Small to Mid-Sized Category Combination Enhances Syneos Health’s Industry-Leading Position Across Fast-Growing Small to Mid-Sized Category

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APstem Therapeutics Announces Successful FDA INTERACT Meeting Regarding AP-Skin-01, an “Off-the-Shelf” Allogeneic Stem Cell Product for the…

By Dr. Matthew Watson

Fremont, CA , Oct. 28, 2020 (GLOBE NEWSWIRE) -- APstem Therapeutics, Inc., a private biopharmaceutical company developing breakthrough stem cell therapies, today announced the completion of an INitial Targeted Engagement for Regulatory Advice on CBER ProducTs (INTERACT) meeting with the U.S. Food and Drug Administration (FDA) Center for Biologics Evaluation and Research (CBER) Office of Tissues and Advanced Therapies (OTAT). The meeting, which included CBER OTAT staff together with the APstem team, focused on the development plan for AP-Skin-01, a novel “off-the-shelf” allogeneic stem cell product derived from adult pluripotent stem cells (APSCs™) for the initial treatment of diabetic ulcers.

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APstem Therapeutics Announces Successful FDA INTERACT Meeting Regarding AP-Skin-01, an “Off-the-Shelf” Allogeneic Stem Cell Product for the...

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Silencil Reviews – Does It Silence Tinnitus for Real?

By Dr. Matthew Watson

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Silencil Reviews – Does It Silence Tinnitus for Real?

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Roche’s Tecentriq in combination with Avastin approved in China for people with the most common form of liver cancer

By Dr. Matthew Watson

Basel, 29 October 2020 – Roche (SIX: RO, ROG; OTCQX: RHHBY) today announced that the China National Medical Products Administration (NMPA) has approved Tecentriq® (atezolizumab) in combination with Avastin® (bevacizumab) for the treatment of people with unresectable hepatocellular carcinoma (HCC) who have not received prior systemic therapy. “Today’s approval of Tecentriq in combination with Avastin for unresectable hepatocellular carcinoma means that people in China now have a cancer immunotherapy option which is changing the treatment landscape for this aggressive disease”, said Levi Garraway, M.D., Ph.D., Roche's Chief Medical Officer and Head of Global Product Development. “With almost half of the world’s hepatocellular carcinoma cases diagnosed in China, this approval marks a major advance for Chinese patients.” “In China, primary liver cancer ranks as the fourth most common malignancy and is the second leading cause of cancer death. With most patients diagnosed at the intermediate and advanced stages where surgery or other locoregional therapies are not an option, there is an urgent need for effective treatments for unresectable HCC”, said Prof. Shukui Qin, Leading Principal Investigator of the IMbrave150 study in China and Chairman of the Liver Cancer Expert Committee of the Chinese Society of Clinical Oncology (CSCO). “The IMbrave150 study demonstrated that the combination of Tecentriq and Avastin in this setting can significantly improve outcomes for patients. It is truly gratifying news that the combination is now approved in China and gives a new option to Chinese liver cancer patients.” Liver cancer is one of the most common cancers in China, accounting for nearly 400,000 diagnoses and approximately 368,000 deaths every year, equivalent to over 1,000 per day.1 Only 20% of people with HCC in China are diagnosed in the early stages, when curative treatments are still an option.2 The average 5-year survival rate for people in China with liver cancer is only approximately 15%.3 Roche is committed to tackling liver disease right across the disease journey, from the earliest stages through to advanced disease, with the ultimate goal of one day stopping chronic liver disease. The approval was based on results of the Phase III IMbrave150 study, which included analyses of a cohort of Chinese patients (n=194) from the same study. Data from this cohort were consistent with the global results. Among Chinese patients, Tecentriq in combination with Avastin reduced the risk of death (overall survival; OS) by 56% (hazard ratio [HR]=0.44; 95% CI: 0.25–0.76) and reduced the risk of disease worsening or death (progression-free survival; PFS) by 40% (HR=0.60; 95% CI: 0.40–0.90), compared with sorafenib. Tecentriq and Avastin were generally well-tolerated with manageable toxicities, and the safety profile was consistent with the known safety profiles of the individual medicines and with the underlying disease. Global results from the IMbrave150 study demonstrated that Tecentriq in combination with Avastin reduced the risk of death (OS) by 42% (HR=0.58; 95% CI: 0.42–0.79; p=0.0006) and reduced the risk of disease worsening or death (PFS) by 41% (HR=0.59; 95% CI: 0.47–0.76; p<0.0001), compared with sorafenib. IMbrave150 is the first Phase III cancer immunotherapy study to show an improvement in OS and PFS in people with unresectable or metastatic HCC compared with sorafenib. Grade 3–4 adverse events occurred in 57% of people receiving Tecentriq and Avastin and 55% of people receiving sorafenib. The most frequent serious adverse reactions (?2%) were bleeding in the gastrointestinal tract and fever. These results were published in the New England Journal of Medicine on 14 May 2020.4  In May 2020, the US Food and Drug Administration approved Tecentriq in combination with Avastin for the treatment of people with unresectable or metastatic HCC who have not received prior systemic therapy. In addition, in September, the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) recommended the approval of Tecentriq in combination with Avastin for the treatment of adult patients with advanced or unresectable hepatocellular carcinoma (HCC) who have not received prior systemic therapy. Tecentriq in combination with Avastin was also recently recommended as a preferred option by the CSCO for the treatment of unresectable HCC, as well as by many clinical practice guidelines globally. Earlier this year, the China NMPA also approved Tecentriq in combination with chemotherapy (carboplatin and etoposide) for the first-line treatment of patients with extensive-stage small cell lung cancer (ES-SCLC), an area of major unmet need and one that has seen limited advances in treatment until now. The submission was based on the results from the positive Phase III IMpower133 study and was the first cancer immunotherapy available in China for the initial treatment of ES-SCLC. Roche has an extensive development programme for Tecentriq, including multiple ongoing and planned Phase III studies, across several types of lung, genitourinary, skin, breast, gastrointestinal, gynaecological, and head and neck cancers. This includes studies evaluating Tecentriq both alone and in combination with other medicines. About the IMbrave150 studyIMbrave150 is a global Phase III, multicentre, open-label study of 501 people with unresectable HCC who had not received prior systemic therapy. People were randomised 2:1 to receive the combination of Tecentriq and Avastin or sorafenib. Tecentriq was administered intravenously (IV), 1200 mg on day 1 of each 21-day cycle, and Avastin was administered IV, 15 mg/kg on day 1 of each 21-day cycle. Sorafenib was administered by mouth, 400 mg twice per day, on days 1-21 of each 21-day cycle. People received the combination or the control arm treatment until disease progression or unacceptable toxicity. The two primary endpoints were OS and independent review facility (IRF)-assessed PFS per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1). Additional study endpoints included IRF-assessed overall response rate (ORR) per RECIST v1.1 and HCC mRECIST. About hepatocellular carcinomaHCC, the most common form of liver cancer, is an aggressive cancer with limited treatment options and is a major cause of cancer deaths worldwide.5 Every year, more than 750,000 people worldwide are diagnosed with HCC,5,6 with the majority of cases in Asia and almost half of all cases in China.1,6 In the US, the number of liver cancer cases have more than tripled since 1980 and HCC represents the fastest-rising cause of cancer-related death, while in Europe, liver cancer is also on the rise.7-9 HCC develops predominantly in people with cirrhosis due to chronic hepatitis (B or C) or alcohol consumption, and typically presents at an advanced stage.5 The prognosis for unresectable HCC remains poor, with few systemic therapeutic options and a 1-year survival rate of less than 50% following diagnosis.10 About the Tecentriq and Avastin combinationThere is a strong scientific rationale to support the use of Tecentriq plus Avastin in combination. The Tecentriq and Avastin regimen may enhance the potential of the immune system to combat a broad range of cancers. Avastin, in addition to its established anti-angiogenic effects, may further enhance Tecentriq’s ability to restore anti-cancer immunity, by inhibiting vascular endothelial growth factor (VEGF)-related immunosuppression, promoting T-cell tumour infiltration and enabling priming and activation of T-cell responses against tumour antigens. About TecentriqTecentriq is a monoclonal antibody designed to bind with a protein called PD-L1, which is expressed on tumour cells and tumour-infiltrating immune cells, blocking its interactions with both PD-1 and B7.1 receptors. By inhibiting PD-L1, Tecentriq may enable the activation of T-cells. Tecentriq is a cancer immunotherapy that has the potential to be used as a foundational combination partner with other immunotherapies, targeted medicines and various chemotherapies across a broad range of cancers. The development of Tecentriq and its clinical programme is based on our greater understanding of how the immune system interacts with tumours and how harnessing a person’s immune system combats cancer more effectively. Tecentriq is approved in the US, EU and countries around the world, either alone or in combination with targeted therapies and/or chemotherapies in various forms of non-small cell and small cell lung cancer, certain types of metastatic urothelial cancer and in PD-L1-positive metastatic triple-negative breast cancer. In the US, China and a number of other countries, Tecentriq in combination with Avastin is approved for a type of liver cancer. About AvastinAvastin is a prescription-only medicine that is a solution for intravenous infusion. It is a biologic antibody designed to specifically bind to a protein called VEGF that plays an important role throughout the lifecycle of the tumour to develop and maintain blood vessels, a process known as angiogenesis. Avastin is designed to interfere with the tumour blood supply by directly binding to the VEGF protein to prevent interactions with receptors on blood vessel cells. The tumour blood supply is thought to be critical to a tumour’s ability to grow and spread in the body (metastasise). About Roche in cancer immunotherapy Roche’s rigorous pursuit of groundbreaking science has contributed to major therapeutic and diagnostic advances in oncology over the last 50 years, and today, realising the full potential of cancer immunotherapy is a major area of focus. With over 20 molecules in development, Roche is investigating the potential benefits of immunotherapy alone, and in combination with chemotherapy, targeted therapies or other immunotherapies with the goal of providing each person with a treatment tailored to harness their own unique immune system to attack their cancer. Our scientific expertise, coupled with innovative pipeline and extensive partnerships, gives us the confidence to continue pursuing the vision of finding a cure for cancer by ensuring the right treatment for the right patient at the right time. In addition to Roche’s approved PD-L1 checkpoint inhibitor, Tecentriq® (atezolizumab), Roche’s broad cancer immunotherapy pipeline includes other checkpoint inhibitors, such as tiragolumab, a novel cancer immunotherapy designed to bind to TIGIT, individualised neoantigen therapies and T-cell bispecific antibodies. To learn more about Roche’s scientific-led approach to cancer immunotherapy, please follow this link: http://www.roche.com/research_and_development/what_we_are_working_on/oncology/cancer-immunotherapy.htm About Roche Roche is a global pioneer in pharmaceuticals and diagnostics focused on advancing science to improve people’s lives. The combined strengths of pharmaceuticals and diagnostics under one roof have made Roche the leader in personalised healthcare – a strategy that aims to fit the right treatment to each patient in the best way possible. Roche is the world’s largest biotech company, with truly differentiated medicines in oncology, immunology, infectious diseases, ophthalmology and diseases of the central nervous system. Roche is also the world leader in in vitro diagnostics and tissue-based cancer diagnostics, and a frontrunner in diabetes management. Founded in 1896, Roche continues to search for better ways to prevent, diagnose and treat diseases and make a sustainable contribution to society. The company also aims to improve patient access to medical innovations by working with all relevant stakeholders. More than thirty medicines developed by Roche are included in the World Health Organization Model Lists of Essential Medicines, among them life-saving antibiotics, antimalarials and cancer medicines. Moreover, for the eleventh consecutive year, Roche has been recognised as one of the most sustainable companies in the Pharmaceuticals Industry by the Dow Jones Sustainability Indices (DJSI). The Roche Group, headquartered in Basel, Switzerland, is active in over 100 countries and in 2019 employed about 98,000 people worldwide. In 2019, Roche invested CHF 11.7 billion in R&D and posted sales of CHF 61.5 billion. Genentech, in the United States, is a wholly owned member of the Roche Group. Roche is the majority shareholder in Chugai Pharmaceutical, Japan. For more information, please visit www.roche.com. All trademarks used or mentioned in this release are protected by law. References [1] World Health Organization: GLOBOCAN 2018 – China factsheet. [Internet; cited 2020 August] Available from: http://gco.iarc.fr/today/data/factsheets/populations/160-china-fact-sheets.pdf.[2] Wu Q, Qin SK. Features and treatment options of Chinese hepatocellular carcinoma. Chin Clin Oncol. 2013;2(4):38. [3] Hassanipour S et al. The survival rate of hepatocellular carcinoma in Asian countries: a systematic review and meta-analysis. EXCLI J. 2020;19:108-130. [4] Finn RS et al. Atezolizumab plus bevacizumab in unresectable hepatocellular carcinoma. N Engl J Med. 2020;382(20):1894-1905.[5] Llovet JM et al. Hepatocellular carcinoma. Nat Rev Dis Primers. 2016;2:16018.[6] World Health Organization: GLOBOCAN 2018 – Liver cancer factsheet. [Internet; cited 2020 August] Available from: http://gco.iarc.fr/today/data/factsheets/cancers/11-Liver-fact-sheet.pdf.[7] American Cancer Society. Key statistics about liver cancer. [Internet; cited 2020 August] Available from: https://www.cancer.org/cancer/liver-cancer/about/what-is-key-statistics.html.[8] Rawla P et al. Update in global trends and aetiology of hepatocellular carcinoma. Contemp Oncol (Pozn). 2018;22(3):141-150.[9] Pimpin L et al. Burden of liver disease in Europe: Epidemiology and analysis of risk factors to identify prevention policies. J Hepatol. 2018;69(3):718-735.[10] Giannini EG et al. Prognosis of untreated hepatocellular carcinoma. Hepatology. 2015;61(1):184-190. Roche Group Media Relations Phone: +41 61 688 8888 / e-mail: media.relations@roche.com

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Roche’s Tecentriq in combination with Avastin approved in China for people with the most common form of liver cancer

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Bone Therapeutics and Catalent sign agreements to streamline production of the allogeneic cell therapy product, ALLOB

By Dr. Matthew Watson

REGULATED INFORMATION

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Bone Therapeutics and Catalent sign agreements to streamline production of the allogeneic cell therapy product, ALLOB

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