Industry News

Nektar and Collaborators Present Late-breaking Results from Phase 2 Study of NKTR-255 for the Treatment of Radiation Induced Lymphopenia in Locally Advanced Non-Small Cell Lung Cancer Patients at Society for Immunotherapy of Cancer (SITC) Annual Meeting

11/14/2024

NKTR-255 administered post completion of concurrent chemoradiation and in combination with durvalumab demonstrated statistically significant lymphocyte recovery compared to historical controls at week 8 – – Pharmacodynamic data show NKTR-255 increased NK cell proliferation and markers of NK cell activation  – Excerpt from the Press Release: SAN FRANCISCO, Nov. 7, 2024 /PRNewswire/ — Nektar Therapeutics (Nasdaq: NKTR)…

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Acumen Pharmaceuticals Presents Innovative Trial Screening Advancements Utilizing pTau217 Assay in Phase 2 Study of Sabirnetug for Early Alzheimer’s Disease at the 17th Annual Clinical Trials on Alzheimer’s Disease Conference

11/11/2024

Late-breaking presentation highlights the pTau217 assay as an effective and efficient tool to screen participants for ALTITUDE-AD that reduces unnecessary amyloid PET scans and lumbar puncture procedures for those who are not eligible Excerpt from the Press Release: NEWTON, Mass., Oct. 31, 2024 (GLOBE NEWSWIRE) — Acumen Pharmaceuticals, Inc. (NASDAQ: ABOS), a clinical-stage biopharmaceutical company…

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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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