Another day, another win for Mercks blockbuster Keytruda.

The FDA has granted accelerated approval for the cash cow combined with chemotherapy in triple negative breast cancer, giving the drug the green light in its 18th different cancer. Mondays new indication comes for patients with PD-L1-expressing tumors with a Combined Positive Score of at least 10.

Merck noted that due to the nature of the accelerated approval, the thumbs up is contingent upon confirmatory trials.

Data for the approval first came back in February, when the Keynote-355 trial demonstrated Keytruda plus chemo significantly improved progression-free survival compared to chemo by itself. The study showed that, in the target population with a CPS of at least 10, the combination reduced the risk of disease progression or death by 35% with a median PFS of 9.7 months, against 5.6 months in the placebo arm.

On safety, the February data showed 2.5% of all patients in the drug arm saw fatal adverse events, including cardiac arrest and septic shock, with serious side effects appearing in 30% of patients. Keytruda was discontinued due to adverse events in 11% of patients.

Frontline triple negative breast cancer is a particularly difficult indication to treat, as the growth of the cancer is not fueled by the hormones estrogen and progesterone, or by the HER2 protein. Its one of the rare fields in which Roches PD-L1 Tecentriq has enjoyed a head start over Keytruda and Opdivo, the leaders in the checkpoint race, as Tecentriq is approved in combination with Abraxane for this indication.

Back in May 2019, Merck conceded a failure in the arena after a Phase III study flopped on overall survival. But a few months later, the pharma turned things around after discovering a neoadjuvant regimen of Keytruda and chemo followed by Keytruda monotherapy after surgery induced a higher pathological complete response rate.

Though execs presented that as a positive, some analysts didnt paint as sunny a picture. This past February, when the Keynote-355 topline data was first published, SVB Leerinks Daina Graybosch pointed out that because only patients with a CPS of at least 10 appeared to benefit, instead of a score of at least 1, it wont be able to treat as broad a population as Tecentriq. Roche, she noted, also has about a two-year head start.

A Merck spokesperson also had this to say about the CPS and IC percentages:

In TNBC, we measure PD-L1 with a combined positive score (CPS). The CPS includes staining for tumor cells, as well as tumor-infiltrating immune cells and it is not a percentage. We believe CPS 10 is roughly equivalent to how Roche scores PD-L1+ patients (IC>=1% based on the SP142 assay) on tumor-infiltrating immune cells (IC). The prevalence of the PD-L1 positive population in TNBC whether by CPS of greater than or equal to 10 or IC of 1% is both about 40%.

Keytruda is already one of the best-selling drugs in the world, having notched roughly $3.9 billion in the first half of 2020 alone. Some have predicted the drug may overtake AbbVies Humira as the top seller within the next few years, with the most optimistic estimate pegged for $22.2 billion in sales by 2025.

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UPDATED: Merck's Keytruda nets another approval, this time in triple negative breast cancer. Can it catch up to Tecentriq? - Endpoints News

During a 2018 home game against Washington State University, David Shaw, Stanford's football coach, ambled slowly along the sideline, his joints aching.

Wanting to focus on the players and the game, he kept the reason for his lethargy to himself. But two years later, this past Saturday, the sports world learned the full story.

A College GameDay feature on ESPN revealed that the morning before the game, Shaw had been given stem-cell-inducing medication at Stanford Hospital. It was a first step in donating the cells to his brother, Eric Shaw, who was fighting a rare form of lymphoma.

In the opening of the six-minute video, Shaw says he thought, "'God, I hope this works, 'cause if it doesn't, I'm going to lose my brother.'"

Eric Shaw began noticing strange dark patches on his skin in 2011, the year his older brother became Stanford's head football coach. They were everywhere, from head to foot. Later, small tumors popped up all over his body.

"I would have itching attacks where I would end up actually tearing my skin," he says in the video. "I would still scratch at night and end up with bloody arms and legs."

Eric Shaw transferred his medical care to the Stanford Cancer Center in 2013. There, physicians told the financial services marketing professional that he needed to start radiation treatment immediately. It worked, but only briefly: Six months later, the cancer returned.

He was diagnosed with mycosis fungoides, a T cell lymphoma that affects fewer than four in a million people in the United States.

Shaw's physicians began discussing bone marrow transplant. David Shaw was tested as a donor, but he scored only 5 on a 10-point match scale. A worldwide search found closer matches, and Eric Shaw underwent radiation and chemotherapy to prepare for the transplant.

One attempt failed, then another.

"You think you've kind of pulled at the last thread, and there are no more threads, and all I could tell him was that I loved him and that I was there for him," David Shaw says in the video.

But the Stanford physicians had one last weapon: a haploidentical transplant. The recently developed technique uses stem cells, typically from a family member, that are less than a perfect match.

David Shaw underwent a five-day-long process at Stanford Hospital to donate the cells. He received medication that caused him to produce an abundance of stem cells, then gave blood from which the cells were extracted. Those cells were then transplanted into his brother.

This time, it worked.

After 52 days at Stanford Hospital, Eric Shaw finally went home on Nov. 25, 2018. The video shows him being wheeled out as medical staff members cheer him on.

Youn Kim, MD, who treated Eric and heads Stanford's multidisciplinary Cutaneous Lymphoma Clinic/Program, told ESPN: "If he didn't go for this risk, he wouldn't be here...He wouldn't be living."

As the article notes, Stanford physicians Wen-Kai Weng, MD, PhD, and Michael Khodadoust, MD, PhD, also were on the team treating Eric Shaw.

Today, nearly two years later, he remains cancer-free.

"Seven years of battling this disease, and it was over," he says in the video, tears running down his face. "A miracle."

David Shaw shares his brother's joy. As he told ESPN: "Every time I see him, I just smile, you know? Because he gets to be here."

Images of Eric Shaw, left, taken earlier this month, and his brother David Shaw, courtesy of the Shaw family, and Stanford Athletics

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Stanford coach's quest to save his brother: 'God, I hope this works' - Scope

MILAN, Italy and NEW YORK, Nov. 16, 2020 (GLOBE NEWSWIRE) -- Genenta Science, a clinical-stage biotechnology company pioneering the development of hematopoietic stem progenitor cell immuno-gene therapy for cancer (Temferon), presents new preliminaryclinical data from a Phase I/IIa study of Temferon in patients affected by glioblastoma multiforme (GBM) at the 2020 Society for Neuro-Oncology (SNO) Annual Meeting, taking place November 19-22 in Austin, TX.

To date, ten patients were enrolled and eight were treated. Temferon was well tolerated, as suggested by the rapid hematological recovery and engraftment of modified cells observed in all the treated patients. No dose limiting toxicities were identified.

T-cell immunorepertoire changes were observed after treatment with evidence for clonal expansion, including tumor associated clones, suggesting a possible reset of T-cell responses, which are known to play a key role in the tumor-induced tolerance.

Interferon-alpha (IFN-) response was identified across a number of tumor infiltrating myeloid cells while a low concentration of IFN- was detected in the plasma and cerebrospinal fluid (CSF) of patients. This provides evidence that the Temferon built-in control mechanism is working to reduce the risk of IFN- off-target effects preserving the desired in situ biological effects.

Pierluigi Paracchi, Chairman and Chief Executive Officer at Genenta Science, said: These preliminary results are exciting indications of the feasibility, safety and local biological activity of our approach. The data are encouraging and in line with our pre-clinical results, with preliminary evidence of changes in the immune system and that Temferon is well tolerated without systemic toxicities.

Temferon-derived differentiated cells, as determined by vector copy number (VCN) in peripheral blood and bone marrow, were evident within 14 days of treatment and persist in peripheral blood in the long term (up to one year). Preliminary data on tumor specimens at second surgery confirmed the presence of TEMs and suggested that a higher IFN response gene signature may occur after treatment in stable lesions, compared to lesions that progress.

About Genenta Science

Genenta (www.genenta.com) is a clinical-stage biotechnology company pioneering the development of a proprietary hematopoietic stem cell gene therapy for cancer. Temferon is based on ex-vivo gene transfer into autologous hematopoietic stem/progenitor cells (HSPCs) to deliver immunomodulatory molecules directly via tumor-infiltrating monocytes/macrophages (Tie2 Expressing Monocytes - TEMs). TemferonTM, which is under investigation in a Phase I/IIa clinical trial in newly diagnosed Glioblastoma Multiforme patients, is not restricted to pre-selected tumor antigens nor type and may reach solid tumors, one of the main unresolved challenge in immuno-oncology. Based in Milan, Italy, and New York, USA, Genenta has raised more than 33.6 million (~$40 million) in three separate rounds of financing.

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Genenta's Temferon: Evidence of Controlled and Targeted Interferon Expression in Preliminary Phase I/II Clinical Data in Glioblastoma MultiformeData...

-Phase 1 INNATE trial will evaluate JTX-8064 as a monotherapy and in combination with Jounce’s PD-1 inhibitor, JTX-4014-

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Jounce Therapeutics Receives Study May Proceed Letter from US FDA to Initiate Phase 1 Clinical Trial of JTX-8064 Targeting the LILRB2/ILT4 Mechanism

NEEDHAM, Mass., Nov. 16, 2020 (GLOBE NEWSWIRE) -- Chiasma, Inc. (NASDAQ: CHMA), a commercial-stage biopharmaceutical company utilizing its delivery platform technology to develop and commercialize oral therapies to improve the lives of patients with rare diseases on burdensome and painful injections, today announced that management will be participating in the Jefferies Virtual London Healthcare Conference, which is being held November 17-19. Details of the presentation are as follows:

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Chiasma to Participate in the Jefferies Virtual London Healthcare Conference

ALCESTER, United Kingdom, Nov. 16, 2020 (GLOBE NEWSWIRE) -- Quanta Dialysis Technologies Ltd (“Quanta” or the “Company”), a British medical technology innovation company, today announces that management will be participating in three upcoming investor conferences.

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Quanta to Participate in Upcoming Virtual Investor Conferences

- Company to receive upfront payment of €5 million replacing a later stage regulatory approval milestone of U.S.$5 million  - Novo Nordisk committing to fund €9 million of the budgeted AEZS-130-P02 (“Study P02”) clinical trial costs for childhood-onset growth hormone deficiency expected to be initiated in Q1 2021

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Aeterna Zentaris Amends License Agreement with Novo Nordisk for Commercialization and Development of Macimorelin

– Continued progress of COVID-19 development programs with additional preclinical studies of coronavirus protease inhibitors (3CL) underway and lead preclinical molecule selection expected by year end –

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Cocrystal Pharma Reports Third Quarter 2020 Financial Results and Provides Update on Antiviral Programs

Title: An Oral Tablet Vaccine – A Potential Global Solution to COVID-19 and Norovirus

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Vaxart Hosting Key Opinion Leader Panel Call for Investors

Granted methods patent for Versamune® platform by the United States Patent and Trademark Office Granted methods patent for Versamune® platform by the United States Patent and Trademark Office

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PDS Biotech Announces New and Broad Versamune® Platform Patent Claims

First patients on track for enrollment this year

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Artelo Biosciences Announces Clinical Trial Authorization to Commence Cancer Appetite Recovery Study for the Treatment of Cancer-Related Anorexia and...

MORRISVILLE, N.C., Nov. 16, 2020 (GLOBE NEWSWIRE) -- Syneos Health® (Nasdaq:SYNH), the only fully integrated biopharmaceutical solutions organization combining a CRO (Contract Research Organization) and a CCO (Contract Commercial Organization), will host an Analyst and Investor Event on Tuesday, December 8, 2020, from 9:00 a.m. to approximately 11:30 a.m. EST.

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Syneos Health to Host Virtual Analyst and Investor Event on December 8, 2020

? Early & High Uric Acid dose dependent association in Acute Kidney Injury from COVID-19 ? ? Early & High Uric Acid dose dependent association in Acute Kidney Injury from COVID-19 ?

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XORTX Announces Topline Results from Mount Sinai’s COVID-19 Clinical Study

WAKEFIELD, Mass., Nov. 16, 2020 (GLOBE NEWSWIRE) -- Innovation Pharmaceuticals (OTCQB:IPIX) (“the Company”), a clinical stage biopharmaceutical company, announces today that an overseas Clinical Trial Application (CTA) has been submitted to the governing health agency, with a U.S. Investigational New Drug (IND) application also to be submitted this week to the FDA. Both these submissions are part of final preparations for the Company’s multinational Phase 2 clinical trial of Brilacidin for COVID-19, which is on track to commence in 2020 upon gaining required approvals.

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Innovation Pharmaceuticals Announces Overseas Regulatory Filing Submitted For COVID-19 Clinical Study

BRISBANE, Calif. and ST. LOUIS, Nov. 16, 2020 (GLOBE NEWSWIRE) -- Arch Oncology, Inc., a clinical-stage immuno-oncology company focused on the discovery and development of anti-CD47 antibody therapies, today announced the appointment of Ronald Krasnow, Esq. as Chief Operating Officer. In this newly created position, Mr. Krasnow will report to Julie Hambleton, M.D., Arch Oncology’s Interim President and Chief Executive Officer.

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Arch Oncology Appoints Ronald Krasnow, Esq. as Chief Operating Officer

BERWYN, Pa., Nov. 16, 2020 (GLOBE NEWSWIRE) -- Annovis Bio Inc. (NYSE American: ANVS), a clinical-stage drug platform company addressing Alzheimer’s disease (AD), Parkinson’s disease (PD) and other neurodegenerative diseases, today announced its CEO, Maria Maccecchini, Ph.D. and CFO, Jeff McGroarty, MBA, CPA, will participate in A.G.P.'s Virtual Healthcare Symposium on Thursday, November 19, 2020.

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Annovis Bio to Participate in A.G.P.'s Virtual Healthcare Symposium

WILLIAMSVILLE, N.Y., Nov. 16, 2020 (GLOBE NEWSWIRE) -- 22nd Century Group, Inc. (NYSE American: XXII), a leading plant-based, biotechnology company that is focused on tobacco harm reduction, very low nicotine content tobacco, and hemp/cannabis research, announced today that the Company will present and meet with investors at the Virtual Fall Investor Summit. The conference is being held virtually November 16 -18, 2020.

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22nd Century Group to Present at the Virtual Fall Investor Summit on November 17

PETALUMA, Calif., Nov. 16, 2020 (GLOBE NEWSWIRE) -- Spectrum Antimicrobials, Inc., a subsidiary of Collidion, Inc. announces the development of a novel antiviral drug candidate designed to treat pulmonary infections. SPC-069 is a new class of therapy designed to treat viral, bacterial, and fungal infections in the lung and respiratory tract. This promising therapy was developed to eradicate not only common pathogens but also those caused by antibiotic resistant strains known as “Super Bugs.” The Company plans to advance this drug candidate into human clinical studies as soon as possible with a partner or upon completion of its financing.

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Spectrum Antimicrobials, Inc. Announces Breakthrough Drug Candidate for Prevention and Treatment of Pulmonary Infections

Submission for Approval Filed in Indication of MSI-H/dMMR Cancer, Including Colorectal and Gastric Cancer Submission for Approval Filed in Indication of MSI-H/dMMR Cancer, Including Colorectal and Gastric Cancer

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TRACON Pharmaceuticals Announces Submission for Approval of Envafolimab (KN035) with the NMPA in China by its Corporate Partners Alphamab Oncology and...

HASBROUCK HEIGHTS, N.J., Nov. 16, 2020 (GLOBE NEWSWIRE) -- Nymox Pharmaceutical Corporation (NASDAQ: NYMX) is pleased to provide a current update on the regulatory filing status for Fexapotide Triflutate (FT), Nymox's first in class lead product for the treatment of benign prostatic hyperplasia (BPH). Substantial progress has been made and there are no material changes to the content of the planned applications.

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Nymox Provides Update on Regulatory Filing Activities