Industry News

ESSA Pharma Announces Termination of Phase 2 Study Evaluating Masofaniten Combined with Enzalutamide in Patients with Metastatic Castration-Resistant Prostate Cancer

11/08/2024

Efficacy signals observed will not achieve ESSA’s target product profile in patients with metastatic castration-resistant prostate cancer naïve to second-generation antiandrogens A futility analysis conducted as part of a protocol-specified interim review of the safety, PK and efficacy data showed the single-agent enzalutamide control arm performing better than historical controls and similar to the combination…

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HiFiBiO Therapeutics Receives FDA Clearance of IND Application for HFB200604, a Best-in-Class BTLA Agonist Antibody for the Treatment of Inflammatory and Immunology Diseases

11/07/2024

Excerpt from the Press Release: CAMBRIDGE, Mass.–(BUSINESS WIRE)–HiFiBiO Therapeutics, a clinical stage biotechnology company focused on immune modulation, today announced that the U.S. Food and Drug Administration (FDA) has cleared its Investigational New Drug (IND) application for HFB200604. HFB200604 is a best-in-class BTLA agonist monoclonal antibody, developed using HiFiBiO’s proprietary Drug Intelligence Science (DIS®) platform.…

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Skye Bioscience Demonstrates Prominent Role of Peripheral CB1 Inhibition and Achieves Significant Weight Loss with Novel CB1-inhibiting Antibody, Nimacimab, in Preclinical Model

11/06/2024

Peripherally-restricted nimacimab achieves significant dose-dependent weight loss, fat mass reduction, lean mass preservation, and glycemic control in diet-induced obesity model Preliminary data shows that nimacimab achieves desired metabolic outcomes without central inhibition and its risk of neuropsychiatric adverse events Excerpt from the Press Release: SAN DIEGO, Nov. 04, 2024 (GLOBE NEWSWIRE) — Skye Bioscience, Inc.…

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Anixa Biosciences and Cleveland Clinic to Present Additional Data from Phase 1 Study of Breast Cancer Vaccine at the 39th Society for Immunotherapy of Cancer (SITC) Annual Meeting

10/31/2024

Excerpt from the Press Release: SAN JOSE, Calif., Oct. 28, 2024 /PRNewswire/ — Anixa Biosciences, Inc. (“Anixa” or the “Company”) (NASDAQ: ANIX), a biotechnology company focused on the treatment and prevention of cancer, today announced a presentation of additional data from the Phase 1 clinical trial of its breast cancer vaccine at the Society for…

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ADONA MEDICAL INITIATES FIRST-IN-HUMAN STUDY WITH ITS NOVEL INTERATRIAL SHUNT FOR PATIENTS WITH HEART FAILURE

10/30/2024

Excerpt from the Press Release: LOS GATOS, Calif., Oct. 27, 2024 /PRNewswire/ — Adona Medical, a Shifamed portfolio company that aims to deliver advanced solutions for heart failure, announced today the successful first-in-human use of its novel interatrial shunt in patients with heart failure. The initial cases were performed by George Khabeishvili, MD, at Tbilisi Heart…

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IgGenix Announces First Patient Dosed in Phase 1 Clinical Trial “ACCELERATE Peanut” Evaluating IGNX001 in Peanut Allergy

10/28/2024

Novel SEQ SIFTER™ discovery platform used to re-engineer original human IgE antibodies into IgG antibodies to block binding and protect against peanut allergen Topline data expected in mid-2025 Excerpt from the Press Release: SOUTH SAN FRANCISCO, Calif., Oct. 16, 2024 /PRNewswire/ — IgGenix, Inc., a clinical-stage biotechnology company pioneering innovative treatments for immune mediated diseases,…

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Rani Therapeutics Announces New Preclinical Pharmacokinetic Data Supporting Transenteric Delivery of GLP-1 Incretin Triagonist

10/25/2024

-Transenteric delivery of incretin triagonist GLP-1, GIP, glucagon receptors mimicking the RaniPill route of administration elicits rapid weight loss and bioavailability comparable to subcutaneous injection – – New pharmacokinetic data provides further evidence of the RaniPill platform’s potential to enable oral delivery of multiple obesity treatments – – Phase 1 study for RT-114, an oral…

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Arialys Therapeutics Announces First Participants Dosed in a Phase 1 Clinical Trial of ART5803, a Precision Medicine for the Treatment of Autoimmune Neuropsychiatric Diseases

10/21/2024

Excerpt from the Press Release: LA JOLLA, Calif.–(BUSINESS WIRE)–Arialys Therapeutics, a clinical-stage biotechnology company pioneering new precision medicines for autoimmune neuropsychiatry, today announced that it has initiated dosing of healthy volunteers in its first clinical trial of ART5803. ART5803 is a therapeutic monoclonal antibody candidate designed to specifically compete with pathogenic autoantibodies targeting the NMDA…

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Vaxess Receives National Institutes of Health Grant to Explore Administering Type 2 Diabetes Treatment via the MIMIX™ Transdermal Patch Platform

10/14/2024

The National Institute of Diabetes and Digestive and Kidney Diseases Awards Vaxess SBIR Phase I Funding to Test Company’s MIMIX Transdermal Patch Platform in Administering GLP-1 RA Therapies Excerpt from the Press Release: CAMBRIDGE, Mass., October 1, 2024 — Vaxess Technologies, Inc., a biotech company developing a novel transdermal patch technology to transform home delivery…

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New Data Presented at ASTRO 2024 Show that Veracyte’s Decipher Prostate Test Predicts Aggressive Prostate Cancer in African American Men

10/11/2024

Findings are from the prospective, multicenter VANDAAM trial Excerpt from the Press Release: SOUTH SAN FRANCISCO, Calif.–(BUSINESS WIRE)–Veracyte, Inc. (Nasdaq: VCYT), a leading cancer diagnostics company, announced that new data from the multicenter, prospective VANDAAM trial show that the Decipher Prostate Genomic Classifier accurately predicts aggressive prostate cancer among African American men with early-stage disease.…

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