Industry News

VBI Vaccines Announces Initiation of Phase 1 Study of Multivalent Coronavirus Vaccine Candidate, VBI-2901

10/06/2022

Initiation of first clinical study of multivalent VBI-2901, designed to increase breadth of protection against COVID-19 and related coronaviruses Preclinical data support broadly reactive immunity of VBI-2901 against a panel of coronavirus variants in mice, which now also includes circulating BA.4 and BA.5 The study is expected to enroll approximately 100 adults in Canada and…

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Cellevolve Bio Submits Investigational New Drug (IND) Application for Global Phase 2, Placebo-controlled Study of CE-VST01-JC for the Treatment of Progressive Multifocal Leukoencephalopathy (PML)

10/04/2022

CE-VST-01-JC is a novel, allogeneic, off-the-shelf, T cell therapy that targets the JC Virus, the virus that causes progressive multifocal leukoencephalopathy (PML) ASCEND-JC is a randomized, double-blind, placebo-controlled, phase 2 study with sites planned across US, Europe, and Canada Licensed and developed in collaboration with QIMR Berghofer Medical Research Institute’s Professor Rajiv Khanna; NIH’s Irene…

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Sonnet BioTherapeutics Announces Progress in Two Phase 1 Dose-Escalation Trials of SON-1010

10/04/2022

The SB101 and SB102 studies have together dosed 19 subjects to date This early review of safety sets the stage for further dose escalation Additional safety and cytokine-specific data are expected during the fourth calendar quarter of 2022 Excerpt from the Press Release: PRINCETON, NJ / ACCESSWIRE / September 21, 2022 / Sonnet BioTherapeutics Holdings,…

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Phio Pharmaceuticals Announces Preclinical Data Demonstrating PH-762 Enhances Persistence of T cells for Tumor Cell Killing as Presented by Helmholtz Munich at the 9th Immunotherapy of Cancer Conference

10/04/2022

Excerpt from the Press Release: MARLBOROUGH, Mass., Sept. 22, 2022 /PRNewswire/ — Phio Pharmaceuticals Corp. ( Nasdaq: PHIO), a clinical stage biotechnology company developing the next generation of therapeutics based on its proprietary self-delivering RNAi (INTASYL™) therapeutic platform, today announced that its research partner, Helmholtz Munich, presented preclinical data showing that Phio’s lead clinical product PH-762, an…

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The New England Journal of Medicine Publishes Pivotal Tofersen Data that Show Benefits in Rare, Genetic Form of ALS

10/03/2022

Publication includes the Phase 3 VALOR SOD1-ALS trial and its open-label-extension study, underscoring the importance of these longer-term data 12-month data show earlier initiation of tofersen slowed decline across critical measures of function and strength in people diagnosed with SOD1-ALS Results offer important learnings regarding the biology of SOD1-ALS and design of ALS clinical trials…

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MEI Pharma Announces Changes to Board of Directors

10/03/2022

Excerpt from the Press Release: SAN DIEGO–(BUSINESS WIRE)–MEI Pharma, Inc. (Nasdaq: MEIP), a late-stage pharmaceutical company focused on advancing new therapies for cancer, today announced that Christine A. White, M.D., has decided to retire and thus does not intend to stand for reelection at the Company’s fiscal year 2023 annual meeting of stockholders after a…

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Vir Biotechnology Announces First Patient Dosed in the Phase 2 SOLSTICE Trial Evaluating VIR-2218 and VIR-3434 for the Treatment of Chronic Hepatitis D Virus Infection

10/03/2022

– Impacting more than 12 million people globally, HDV is the most aggressive form of viral hepatitis – – Novel combination strategy designed to reduce HDV viremia and block viral entry – Excerpt from the Press Release: SAN FRANCISCO, Sept. 22, 2022 (GLOBE NEWSWIRE) — Vir Biotechnology, Inc. (Nasdaq: VIR) today announced that the first…

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New Data Published in JNCI Demonstrate Veracyte’s Decipher Prostate Genomic Classifier May Improve Identification of Aggressive Prostate Cancer in African American Men

09/30/2022

Excerpt from the Press Release: SOUTH SAN FRANCISCO, Calif.–(BUSINESS WIRE)–Veracyte, Inc. (Nasdaq: VCYT) announced that data published today in the Journal of the National Cancer Institute demonstrate that the company’s Decipher Prostate Genomic Classifier may help identify African American men with early, localized prostate cancer who are most likely to harbor more aggressive disease. The…

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Revolution Medicines Doses First Patient in Phase 1/1b Clinical Trial of RMC-6291, Company’s First Mutant-Selective RAS(ON) Inhibitor

09/30/2022

KRASG12C(ON) Inhibitor with highly differentiated mechanism of action being evaluated in patients with cancers harboring KRASG12C mutation RMC-6291 is first mutant-selective RAS(ON) Inhibitor to enter clinic, following closely behind company’s RASMULTI(ON) Inhibitor, RMC-6236 Excerpt from the Press Release: REDWOOD CITY, Calif., Sept. 22, 2022 (GLOBE NEWSWIRE) — Revolution Medicines, Inc. (Nasdaq: RVMD), a clinical-stage oncology…

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Better Therapeutics Submits De Novo Request to U.S. FDA for BT-001 Investigational Prescription Digital Therapy for Type 2 Diabetes

09/30/2022

Submission follows completion of first-in-class trial demonstrating significant improvements in A1c reduction with investigational therapy targeting the root causes of type 2 diabetes. Excerpt from the Press Release: SAN FRANCISCO–(BUSINESS WIRE)–Better Therapeutics, Inc. (NASDAQ: BTTX), a prescription digital therapeutics (PDT) company developing a novel form of cognitive behavioral therapy (CBT) to address the root causes…

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