Walnut Creek, CA; Boston, MA, Oct. 04, 2022 (GLOBE NEWSWIRE) -- Dark Horse Consulting Group ("DHC"), the leading global consultancy to the cell and gene therapy (“CGT”) industry, and WestView Capital Partners (“WestView”), a Boston-based growth equity firm, are pleased to jointly announce that WestView has completed a growth investment in DHC.

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Correction: Dark Horse Consulting Group Welcomes Growth Investment from WestView Capital Partners

Chief Visionary Officer of Psycheceutical, Zappy Zapolin, will join other prominent leaders in Psychedelics on Benzinga’s Council Board Chief Visionary Officer of Psycheceutical, Zappy Zapolin, will join other prominent leaders in Psychedelics on Benzinga’s Council Board

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Psycheceutical Bioscience, Inc.'s Zappy Zapolin Added to The Benzinga Psychedelics Advisory Council

ZURICH, Switzerland, Oct. 04, 2022 (GLOBE NEWSWIRE) -- Araris Biotech AG (“Araris” or “the Company”), a company pioneering a proprietary antibody-drug conjugate (ADC)-linker technology, today announced the closing of a $24 million financing round, bringing the total funds raised to $40 million to date.

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Araris Biotech Closes $24 Million Financing Round

Industry veteran brings nearly 20 years of broad leadership experience in biopharma Industry veteran brings nearly 20 years of broad leadership experience in biopharma

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BlueSphere Bio Appoints Keir Loiacono as Chief Executive Officer

Company announcement no. 16 - 224 October 2022

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Transactions in connection with share buy-back program

Company announcement – No. 43 / 2022

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Zealand Pharma announces directed issue and private placement of approximately 4.5m new shares

Monthly information related to total number of voting rights and shares composing the share capital _September 30, 2022.

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Monthly information related to total number of voting rights and shares composing the share capital _September 30, 2022

LOS ANGELES, Oct. 04, 2022 (GLOBE NEWSWIRE) -- Trethera Corporation (“Trethera”), a clinical stage biopharmaceutical company committed to developing novel drugs targeting nucleotide metabolism for the treatment of cancer and autoimmune diseases, announces an upcoming poster presentation at the 147th Annual Meeting of the American Neurological Association (ANA). Dr. Peter M. Clark, of the University of California Los Angeles, will present preclinical research highlighting the use of Trethera’s deoxycytidine kinase (dCK) inhibitor, TRE-515, to selectively inhibit symptoms in experimental autoimmune encephalomyelitis (EAE) mouse models of multiple sclerosis (MS). The ANA meeting is one of the largest annual gatherings of MS researchers and a key venue for presenting noteworthy neurology discoveries. The work presented by Dr. Clark also has application for optic neuritis, a rare neurologic disease which affects the optic nerve causing visual impairment. TRE-515 is currently being evaluated in a Phase 1 dose escalation solid tumors study.

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Trethera Announces Multiple Sclerosis Treatment Poster Presentation at the American Neurological Association Annual Meeting

Saint Herblain (France), October 4, 2022 – Valneva SE (Nasdaq: VALN; Euronext Paris: VLA) (the “Company”), a specialty vaccine company, announced today the closing of its previously announced global offering to specified categories of investors of an aggregate 21,000,000 new ordinary shares, consisting of a public offering of 375,000 American Depositary Shares (“ADSs”), each representing two ordinary shares, in the United States at an offering price of $9.51 per ADS (the “U.S. Offering”), and a concurrent private placement of 20,250,000 ordinary shares in Europe (including France) and other countries outside of the United States at the corresponding offering price of €4.90 per ordinary share (the “European Private Placement”, and, together with the U.S. Offering, the “Global Offering”). Aggregate gross proceeds of the Global Offering, before deducting underwriting commissions and estimated expenses payable by the Company, were approximately €102.9 million ($99.9 million).

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Valneva Announces Closing of Upsized €102.9 Million Global Offering

- IVX-A12 is the first combination bivalent vaccine candidate against both respiratory syncytial virus (RSV) and human metapneumovirus (hMPV) to reach clinical stage -

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Icosavax Initiates Phase 1 Trial of IVX-A12 Against RSV and hMPV in Older Adults

BELTSVILLE, Md., Oct. 04, 2022 (GLOBE NEWSWIRE) -- NextCure, Inc. (Nasdaq: NXTC), a clinical-stage biopharmaceutical company committed to discovering and developing novel, first-in-class immunomedicines to treat cancer and other immune-related diseases, today announced the initiation of a Phase 1b/2 clinical trial to evaluate NC410 in combination with KEYTRUDA® (pembrolizumab), Merck’s anti-PD-1 therapy, in patients with immune checkpoint refractory or immune checkpoint naïve solid tumors. In addition, NextCure announced it has entered into a supply agreement for KEYTRUDA with Merck (known as MSD outside the United States and Canada).

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NextCure Announces Initiation of Phase 1b/2 Clinical Trial to Evaluate NC410 in Combination with KEYTRUDA® (Pembrolizumab) in Patients with Immune...

CAMBRIDGE, Mass., Oct. 04, 2022 (GLOBE NEWSWIRE) -- Mersana Therapeutics, Inc. (NASDAQ:MRSN), a clinical-stage biopharmaceutical company focused on discovering and developing a pipeline of antibody-drug conjugates (ADCs) targeting cancers in areas of high unmet medical need, today announced that on October 3, 2022, an authorized sub-committee of the Compensation Committee of the Board of Directors of Mersana granted inducement awards, consisting of restricted stock unit awards (RSUs) to acquire an aggregate of 27,000 shares of its common stock, to six new employees whose employment commenced in September 2022. The awards were granted pursuant to terms and conditions fixed by the Compensation Committee and as an inducement material to each new employee entering employment with Mersana in accordance with Nasdaq Listing Rule 5635(c)(4).

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Mersana Therapeutics Announces Inducement Grants Under Nasdaq Listing Rule 5635(c)(4)

NEW YORK, Oct. 04, 2022 (GLOBE NEWSWIRE) -- Dante Genomics, a global leader in genomics and precision medicine, is pleased to announce that the Company’s co-founder and CEO Andrea Riposati presented as an opening speaker on Tuesday, September 27, 2022 at the 77th United Nations General Assembly (UNGA) Science Summit, where he unveiled the Company’s Digital Health Population Genomics Program in Europe, including living labs, which are groundbreaking pilot studies with fast impact on a country’s society and digital health.

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Dante Genomics Unveils Digital Health Population Genomic Programs at the United Nations General Assembly Science Summit

Company announcement – No. 44 / 2022

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Zealand Pharma announces completion of a directed issue and private placement of 4,975,000 new ordinary shares raising gross proceeds of approx. DKK...

- Meeting adjourned to October 10, 2022 at 11 a.m. PST- GTB encourages all stockholders of record on August 8, 2022 who have not yet voted- to do so by 11:59 p.m. PST Time on October 9, 2022

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GT Biopharma Announces Adjournment of Special Shareholders Meeting

MIAMI, Oct. 04, 2022 (GLOBE NEWSWIRE) -- Veru Inc. (NASDAQ: VERU), a biopharmaceutical company focused on developing novel medicines for COVID-19 and other viral and ARDS-related diseases and for the management of breast and prostate cancers, today announced the granting of inducement awards to seven new employees. In accordance with NASDAQ Listing Rule 5635(c)(4), the awards were made as a material inducement to the seven employees’ entry into employment with the Company.

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Veru Reports Inducement Grants Under NASDAQ Listing Rule 5635(c)(4)

Basel, 05 October 2022 - Roche (SIX: RO, ROG; OTCQX: RHHBY) today announced that new data from its industry-leading neuromuscular portfolio will be presented at the World Muscle Society (WMS) congress, 11th-15th October 2022. These data demonstrate Roche’s commitment to advancing clinical understanding and supporting the development of treatments for people living with neuromuscular disorders.

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Roche to present new data from its expanding neuromuscular disease portfolio at World Muscle Society 2022

AMSBIO has published an interview with Professor Marius Wernig from Stanford University, Pathology Stem Cell Institute that discusses what could be the worlds first widely applicable curative treatment for Epidermolysis Bullosa (EB).

This rare genetic disease causes chronic and incredibly painful skin wounds that often lead to an aggressive form of skin cancer and eventual death.

While various cell-therapy approaches have been attempted, Professor Wernig and collaborators identified the need for induced pluripotent stem cells (iPSCs), and how they could become used to treat EB in a more efficient, applicable, and commercially viable manner.

In the past, the only way Professor Wernigs research group could grow iPSCs cells with a normal karyotype over longer periods of time was on mouse feeder cells with serum. This combination of mouse cell co-culture and undefined bovine serum set was not a suitable methodology as it was almost impossible to perform in compliance with FDA safety standards.

Professor Wernig describes how StemFit Basic03 clinical grade stem cell culture medium, available from AMSBIO has allowed his research group to safely expand their cells using an FDA compliant protocol. While there are still hurdles to climb before a cure for EB is fully realised, using StemFit Basic03 has solved the challenge of reproducibly growing clinical grade iPSCs.

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Completely free of animal- and human-derived components StemFit Basic03 provides highly stable and reproducible culture condition for Induced Pluripotent Stem and Embryonic Stem cells under feeder-free conditions during the reprogramming, expansion, and differentiation phases of stem cell culture. StemFit Basic03 combines high colony forming efficiency with lower than standard media volume consumption to offer cost effective colony expansion when compared to leading competitors.

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iPS-Cell Based Cell Therapies for Genetic Skin Disease

JCR Pharmaceuticals Co., Ltd. and Sysmex Corporation announced that they have established a joint venture(hereafter the "joint venture") for carrying out research and development, manufacture and sales of cell-based regenerative medicine products including hematopoietic stem cells and other stem cells. In recent years, the significant potential of regenerative medicine and cell therapy have been established in particular in areas that have traditionally been difficult to address with conventional chemically synthesized low molecular weight drugs1 or biopharmaceuticals2, such as the restoration of tissues and functions lost as a result of aging, illness, autoimmune diseases, or cancer. In particular, research and development on the therapeutic application of stem cells including hematopoietic stem cells, mesenchymal stem cells, and iPS cells have generated significant attention. Since its inception, JCR has been engaged in the research, development, manufacturing and sales of pharmaceutical products using regenerative medicine, genetic engineering, and gene therapy technologies to advance therapies in the rare disease field. This is exemplified in the field of regenerative medicine, by the approval of TEMCELL HS Inj.3, the first allogeneic regenerativemedicine in Japan (Non-proprietary name: Human (allogeneic) bone marrow-derived mesenchymal stem cells) in February 2016 for the treatment of acute graft-versus-host disease (acute GVHD)4, a serious complication that develops after hematopoietic stem cell transplantation. In recent years, JCR has further streamlined and integrated its expertise around the establishment of groundbreaking medicines for the advancement of highly innovative medicines that could not be developed without such groundbreaking technologies. In the joint venture, the two companies aim to realize the social implementation of regenerative medicine and cell therapy by integrating JCR's expertise in developing, manufacturing and marketing regenerative medicine products, with Sysmex's expertise in quality control testing technology and knowledge of workflows efficiency using robotics technology, including IoT. AlliedCel Corporation, which is the corporate name of the joint venture following prior discussions regarding the alliance both companies, was established on October 3, 2022. The joint venture will advance programs of the potential for technology development and commercialization, including the project currently being promoted by both companies using hematopoietic stem cell proliferation technology. The name AlliedCel stands for the joint venture's aspiration to integrate knowledge and expertise from a broad set of collaborators and stakeholders including business partners, patients and their families, with the united goal of unleashing the power of cells in supporting patients in their needfor life-changing therapies. Through the research and development of regenerative medicineproducts using diverse cells such as stem cells, AlliedCel aims to provide appropriate treatmentoptions to patients and improve their prognosis.

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Jcr Pharmaceuticals Co., Ltd. and Sysmex Establish A Joint Venture in the Field of Regenerative Medicine and Cell Therapy - Marketscreener.com

MeiraGTx

Multiple Poster Presentations Highlight Versatility and Novelty of MeiraGTxs Technology Platforms for Gene and Cell Therapy

LONDONandNEW YORK, Oct. 04, 2022 (GLOBE NEWSWIRE) -- MeiraGTx Holdings plc(Nasdaq: MGTX), a vertically integrated, clinical stage gene therapy company, today announced the Company will exhibit 15 poster presentations at the European Society of Gene and Cell Therapy (ESGCT) 2022 Annual Congress, which will be held from October 11-14, 2022, in Edinburgh, Scotland.

The posters will include data from MeiraGTxs novel gene regulation platform, including the first data demonstrating the potential to regulate CAR-T, as well as data from the Companys promoter platforms and several new, optimized pre-clinical programs addressing severe unmet needs for indications such as amyotrophic lateral sclerosis (ALS) and Wilsons disease. In addition, the Company will have presentations on its proprietary viral vector manufacturing technology and potency assay development.

Were pleased to present data illustrating the depth and versatility of MeiraGTxs scientific platforms, said Alexandria Forbes, Ph.D., president and chief executive officer of MeiraGTx. The 15 published abstracts at this years ESGCT Congress reflect the extraordinary productivity of our research efforts in developing new technologies and applying them to the design of optimized genetic medicines, as well as innovation in manufacturing and process development technology. I am particularly excited for us to present our riboswitch gene regulation technology applied to cell therapy for the first time, in this case the regulation of CAR-Ts, which is a huge area of scientific and clinical interest, continued Dr. Forbes. We look forward to presenting these data highlighting our innovative platform technologies and broad R&D capabilities.

Abstract Title (P101): AI-driven promoter optimization at MeiraGTxSession Title: Advances in viral and non-viral vector designDate: October 12, 2022

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Abstract Title (P124): Promoter Engineering Platform at MeiraGTxSession Title: Advances in viral and non-viral vector designDate: October 13, 2022

Abstract Title (P243): UPF1 delivered by novel expression-enhanced promoters protects cultured neurons in a genetic ALS modelSession Title: CNS and sensoryDate: October 12, 2022

Abstract Title (P254): Optimization and scale-up of AAV2-AQP1 production using a novel transient transfection agentSession Title: Developments in manufacturing and scale upDate: October 13, 2022

Abstract Title (P264): Designing and screening formulations to improve manufacturability and distribution of AAV gene therapiesSession Title: Developments in manufacturing and scale upDate: October 13, 2022

Abstract Title (P270): Use of anion exchange chromatography to provide high empty AAV capsid removal and product yieldsSession Title: Developments in manufacturing and scale upDate: October 13, 2022

Abstract Title (P320): Multivariate analysis for increased understanding of MeiraGTx upstream processSession Title: Developments in manufacturing and scale upDate: October 13, 2022

Abstract Title (P362): Development of AAV-UPF1 gene therapy to rescue ALS pathophysiology using microfluidic platformsSession Title: Disease models (iPS derived and organoids)Date: October 13, 2022

Abstract Title (P399): Titratable and reversible control of CAR-T cell receptor and activity by riboswitch via oral small moleculeSession Title: Engineered T and NK CARs and beyondDate: October 12, 2022

Abstract Title (P436): Novel riboswitches regulate AAV-delivered transgene expression in mammals via oral small molecule inducersSession Title: Gene and epigenetic editingDate: October 13, 2022

Abstract Title (P553): Development of optimized ATP7B gene therapy vectors for the treatment of Wilsons Disease with increased potencySession Title: Metabolic diseasesDate: October 12, 2022

Abstract Title (P554): A CNS-targeted gene therapy for the treatment of obesitySession Title: Metabolic diseasesDate: October 13, 2022

Abstract Title (561): Riboswitch-controlled delivery of therapeutic hormones for gene therapySession Title: Metabolic diseasesDate: October 12, 2022

Abstract Title (P622): Riboswitch-controlled delivery of therapeutic antibodies for gene therapySession Title: OtherDate: October 13, 2022

Abstract Title (P630): Improving AAV in vitro transducibility for cell-based potency assay developmentSession Title: OtherDate: October 13, 2022

About MeiraGTxMeiraGTx (Nasdaq: MGTX) is a vertically integrated, clinical stage gene therapy company with six programs in clinical development and a broad pipeline of preclinical and research programs. MeiraGTx has core capabilities in viral vector design and optimization and gene therapy manufacturing, and a transformative gene regulation platform technology which allows tight, dose responsive control of gene expression by oral small molecules with dynamic range that can exceed 5000-fold. Led by an experienced management team, MeiraGTx has taken a portfolio approach by licensing, acquiring, and developing technologies that give depth across both product candidates and indications. MeiraGTxs initial focus is on three distinct areas of unmet medical need: ocular, including inherited retinal diseases and large degenerative ocular diseases, neurodegenerative diseases, and severe forms of xerostomia. Though initially focusing on the eye, central nervous system, and salivary gland, MeiraGTx plans to expand its focus to develop additional gene therapy treatments for patients suffering from a range of serious diseases.

For more information, please visit http://www.meiragtx.com.

Forward Looking StatementThis press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. All statements contained in this press release that do not relate to matters of historical fact should be considered forward-looking statements, including, without limitation, statements regarding our product candidate development and our pre-clinical data and reporting of such data and the timing of results of data, including in light of the COVID-19 pandemic, as well as statements that include the words expect, will, intend, plan, believe, project, forecast, estimate, may, could, should, would, continue, anticipate and similar statements of a future or forward-looking nature. These forward-looking statements are based on managements current expectations. These statements are neither promises nor guarantees, but involve known and unknown risks, uncertainties and other important factors that may cause actual results, performance or achievements to be materially different from any future results, performance or achievements expressed or implied by the forward-looking statements, including, but not limited to, our incurrence of significant losses; any inability to achieve or maintain profitability, raise additional capital, repay our debt obligations, identify additional and develop existing product candidates, successfully execute strategic priorities, bring product candidates to market, expansion of our manufacturing facilities and processes, successfully enroll patients in and complete clinical trials, accurately predict growth assumptions, recognize benefits of any orphan drug designations, retain key personnel or attract qualified employees, or incur expected levels of operating expenses; the impact of the COVID-19 pandemic on the status, enrollment, timing and results of our clinical trials and on our business, results of operations and financial condition; failure of early data to predict eventual outcomes; failure to obtain FDA or other regulatory approval for product candidates within expected time frames or at all; the novel nature and impact of negative public opinion of gene therapy; failure to comply with ongoing regulatory obligations; contamination or shortage of raw materials or other manufacturing issues; changes in healthcare laws; risks associated with our international operations; significant competition in the pharmaceutical and biotechnology industries; dependence on third parties; risks related to intellectual property; changes in tax policy or treatment; our ability to utilize our loss and tax credit carryforwards; litigation risks; and the other important factors discussed under the caption Risk Factors in our Quarterly Report on Form 10-Q for the quarter ended June 30, 2022, as such factors may be updated from time to time in our other filings with the SEC, which are accessible on the SECs website at http://www.sec.gov. These and other important factors could cause actual results to differ materially from those indicated by the forward-looking statements made in this press release. Any such forward-looking statements represent managements estimates as of the date of this press release. While we may elect to update such forward-looking statements at some point in the future, unless required by law, we disclaim any obligation to do so, even if subsequent events cause our views to change. Thus, one should not assume that our silence over time means that actual events are bearing out as expressed or implied in such forward-looking statements. These forward-looking statements should not be relied upon as representing our views as of any date subsequent to the date of this press release.

Contacts

Investors:MeiraGTxInvestors@meiragtx.com

Media:Jason Braco, Ph.D.LifeSci Communicationsjbraco@lifescicomms.com

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MeiraGTx Announces the Upcoming Presentation of 15 Abstracts at the European Society of Gene and Cell Therapy (ESGCT) 2022 Annual Congress - Yahoo...