Month: November 2024

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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Meet with Christopher Kata and the TrialStat team during the Clinical Outsourcing Group CRO Summit, December 3rd – 4th in Raleigh, NC!

11/12/2024

Meet with Christopher Kata, Director of Sales & Marketing December 3rd – 4th, 2024 at the Clinical Outsourcing Group CRO Summit Raleigh, NC! If you’re attending be sure to to reach out to Christopher to schedule a one on meeting or just drop by booth at your convenience! We’re looking forward to providing live, personalized…

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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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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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