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89bio Presents New Analyses Evaluating Pegozafermin and Potential Benefit of Non-Invasive Tests from the ENLIVEN Phase 2b Trial in MASH Patients at AASLD The Liver Meeting® 2024

11/20/2024

New post-hoc analyses reinforce pegozafermin’s potential anti-fibrotic effects and the potential utility of non-invasive tests which correlate to histological endpoints Excerpt from the Press Release: SAN FRANCISCO, Nov. 15, 2024 (GLOBE NEWSWIRE) —  89bio, Inc. (Nasdaq: ETNB), a clinical-stage biopharmaceutical company focused on the development and commercialization of innovative therapies for the treatment of liver…

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HUYABIO Validates Protective Mechanism for Antiarrhythmic Drug HBI-3000 in AF Patients, Paving the Way for a New Era in Atrial Fibrillation Treatment

11/19/2024

Excerpt from the Press Release: HBI-3000 Aims to Fill Critical Gaps in Atrial Fibrillation Care; Key Data to be Presented at the American Heart Association Annual Meeting SAN DIEGO, Nov. 14, 2024 /PRNewswire/ — HUYABIO International today announced the presentation of new patient data for HBI-3000, an antiarrhythmic drug (AAD) with a unique protective profile for the treatment of atrial fibrillation (AF), one of the most common and serious heart conditions worldwide. This promising drug will be highlighted in a moderated poster presentation in the session entitled “The Return of Antiarrhythmic Drug Therapy: A New Age…

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HUYABIO Presents Positive Phase 2 Data on HBI-8000 and Nivolumab Combination for Advanced Melanoma

11/18/2024

Data supporting the potential for innovative combinations like HBI-8000 and nivolumab to reshape the future of melanoma treatment will be presented at the Society for Immunotherapy of Cancer Annual Meeting Excerpt from the Press Release: SAN DIEGO, Nov. 8, 2024 /PRNewswire/ — HUYABIO International today announced it will present the final analysis of data from a phase…

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Synthekine Announces Presentation of New Translational Data from Phase 1a/1b Clinical Trial of α/β Biased IL-2, STK-012, at the Society for Immunotherapy of Cancer (SITC) 39th Annual Meeting

11/15/2024

Treatment with STK-012 monotherapy demonstrates dose-dependent induction of pro-inflammatory cytokines and selective proliferation of antigen-activated T cells, along with significant expansion of TCR clonality Company will also present new preclinical and GLP toxicology data on STK-026, its biased IL-12 partial agonist also designed for preferential activity on antigen-activated T cells Excerpt from the Press Release:…

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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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Strong Evidence of AU-007’s Anti-Tumor Activity in Advanced Solid Tumor Cancers Presented at Society for Immunotherapy of Cancer (SITC) Annual Meeting

11/13/2024

Excerpt from the Press Release: LARKSPUR, Calif.–(BUSINESS WIRE)–Aulos Bioscience, an immuno-oncology company working to revolutionize cancer care through development of potentially best-in-class IL-2 therapeutics, today shared positive results from its Phase 1/2 dose escalation and cohort expansion study of AU-007. The data will be presented in a poster session at the Society for Immunotherapy of…

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Verastem Oncology Completes Rolling NDA Submission to the FDA for Avutometinib Plus Defactinib as a Treatment for Recurrent KRAS Mutant Low-Grade Serous Ovarian Cancer

11/12/2024

Recurrent low-grade serous ovarian cancer is a rare cancer with no FDA-approved treatments Company seeking accelerated approval and priority review of its NDA submission in patients with KRAS mutant low-grade serous ovarian cancer; FDA filing decision expected before the end of 2024 with potential for FDA approval decision by mid-2025 Excerpt from the Press Release:…

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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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