Announcements

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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Maze Therapeutics Reports Positive First-in-Human Data from Phase 1 Healthy Volunteer Clinical Trial Evaluating MZE829 as a Potential Treatment for APOL1 Kidney Disease (AKD)

11/05/2024

MZE829 Well-tolerated with Dose-proportional Pharmacokinetics Supporting Once Daily Dosing Data Support Advancement of MZE829 into Planned Phase 2 Clinical Trial in Patients with AKD Data Presented Today at the American Society of Nephrology Kidney Week 2024 Excerpt from the Press Release: SOUTH SAN FRANCISCO, CA., October 25, 2024 – Maze Therapeutics, a clinical-stage biopharmaceutical company…

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Evoke Pharma & EVERSANA Announce Statistically Significant Improvement in Patient Outcomes for GLP-1 users with Diabetic Gastroparesis using GIMOTI®

11/04/2024

Analysis of real-world data compared patients on GIMOTI (n=51) to Oral Metoclopramide (n=41), both taking GLP-1s, showing significant statistical improvement for GIMOTI over Oral Metoclopramide in All Cause Emergency Department Visits (-91%, p=0.001), All Cause Office Visits (-41%, p=0.027) and All Cause Hospital Outpatient Visits (-89%, p=0.032) within 6-month index period Data presented at American…

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Candel Therapeutics Showcases Innovative Cancer Therapy Candidates at 16th Annual International Oncolytic Virotherapy Conference (IOVC)

11/01/2024

Excerpt from the Press Release: NEEDHAM, Mass., Oct. 28, 2024 (GLOBE NEWSWIRE) — Candel Therapeutics, Inc. (Candel or the Company) (Nasdaq: CADL), a clinical-stage biopharmaceutical company focused on developing multimodal biological immunotherapies to help patients fight cancer, today announced three presentations at the 16th Annual International Oncolytic Virotherapy Conference (IOVC), taking place October 27-30, 2024,…

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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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Triumvira Immunologics Announces Publication Demonstrating the Safety and Efficacy of TAC T Cells Targeting Claudin 18.2 in Solid Tumors

10/29/2024

Excerpt from the Press Release: SAN DIEGO and AUSTIN, Texas and HAMILTON, ON, Oct. 15, 2024 /PRNewswire/ — Triumvira Immunologics, a clinical-stage company developing novel, targeted autologous and allogeneic T cell therapeutics that co-opt the natural biology of T cells to treat patients with solid tumors, today announced the publication of a peer-reviewed article titled “Preclinical development…

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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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