Month: August 2022

Cyclerion Therapeutics Announces Positive Topline Clinical Data for CY6463 in Patients with Cognitive Impairment Associated with Schizophrenia (CIAS)

08/08/2022

Study data demonstrate positive effects of CY6463 on cognition and inflammation after two weeks of dosing in patients with stable schizophrenia on standard of care Oral, once-daily CY6463 was well tolerated, with no reports of serious adverse events (SAEs) or treatment discontinuation due to adverse events (AEs) Data demonstrate the translation of sGC multi-dimensional pharmacology…

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Cortexyme Successfully Completes Phase 1 Single and Multiple Ascending Dose Clinical Trial of COR588

08/08/2022

Once daily dose of COR588 over 10-day period well-tolerated with no serious adverse events observed Excerpt from the Press Release: SOUTH SAN FRANCISCO, Calif.–(BUSINESS WIRE)–Cortexyme, Inc. (Nasdaq: CRTX), a clinical-stage biopharmaceutical company focused on advancing therapeutics for rare and degenerative diseases, today reported the successful completion of its Phase 1 single ascending dose and multiple…

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IDEAYA Announces IDE397 Clinical Program Update and ctDNA Molecular Responses Demonstrating Tumor Pharmacodynamic Modulation

08/08/2022

Initiated monotherapy expansion cohorts with enrollment open for NSCLC and esophagogastric tumors with MTAP deletion Initiated combination dose escalation cohorts with enrollment open for combinations with taxanes and separately, with potential first-in-class combinations, including pemetrexed Entered into Clinical Trial Collaboration and Supply Agreement with Amgen to clinically evaluate IDE397 in combination with AMG 193, Amgen’s…

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Regen BioPharma, Inc. Files Provisional Patent Application on Second Generation Survivin mRNA Cancer Immunotherapy Vaccine

08/05/2022

Novel Means of Leveraging Cellular Therapy to “Teach” Immune System to Seek and Destroy Cancer Excerpt from the Press Release: SAN DIEGO, July 26, 2022 /PRNewswire/ — Regen BioPharma, Inc. (OTC PINK: RGBP) (OTC PINK: RGBPP), announced today  the filing with the United States Patent and Trademark Office  of a provisional patent application covering utilization of…

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AISA Pharma Announces Positive Data Safety Monitoring Board Review of First Phase 2 Data of Profervia® to treat Raynaud’s Disease in Scleroderma Patients

08/05/2022

Company to Move Forward with Key U.S. Regulatory Applications – Investigational New Drug and Orphan Drug Designation BOSTON, July 26, 2022 (GLOBE NEWSWIRE) — Aisa Pharma, Inc. a privately-funded, clinical-stage biopharmaceutical company, today announced that the Data Safety Monitoring Board (DSMB) for the RECONNOITER Phase 2 study of Aisa’s Profervia® once-daily novel, oral calcium-channel antagonist…

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Alnylam Uncovers Genetic Mutations in INHBE That Protect Against Abdominal Obesity

08/05/2022

– Publication in Nature Communications Reports that People with Loss of Function Mutations in the INHBE Gene Have Reduced Abdominal Fat, a Favorable Metabolic Profile, and are at Lower Risk of Cardiovascular Disease and Type 2 Diabetes – – Alnylam to Pursue INHBE as a Therapeutic Target for Cardiometabolic Disease – Excerpt from the Press…

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Certara Announces Collaboration with Leading Cancer Center to Advance CAR T-cell Therapies

08/04/2022

Certara and Memorial Sloan Kettering Cancer Center to develop biosimulation platform for CAR T-cell therapies Excerpt from the Press Release: PRINCETON, N.J., July 28, 2022 (GLOBE NEWSWIRE) — Certara, Inc. (Nasdaq: CERT), a global leader in biosimulation, today announced a 2-year collaboration with Memorial Sloan Kettering Cancer Center (MSK) to develop new biosimulation software. Certara…

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Bristol Myers Squibb Provides Update on CheckMate -914 Trial Evaluating Opdivo (nivolumab) Plus Yervoy (ipilimumab) as Adjuvant Treatment of Localized Renal Cell Carcinoma

08/04/2022

Excerpt from the Press Release: PRINCETON, N.J.–(BUSINESS WIRE)–Bristol Myers Squibb (NYSE: BMY) today announced that Part A of the Phase 3 CheckMate -914 trial, evaluating Opdivo (nivolumab) plus Yervoy (ipilimumab) as an adjuvant treatment for patients with localized renal cell carcinoma (RCC) who have undergone full or partial removal of the kidney and who are at moderate or high risk…

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Enanta Pharmaceuticals Announces Positive Data from a Phase 1 Clinical Study of EDP-235, its Oral 3CL Protease Inhibitor Designed for the Treatment of COVID-19

08/04/2022

– 200mg and 400mg Once-Daily Doses Achieved Strong Exposure Multiples Over EC90 and Were Generally Safe and Well-Tolerated – Plan to Initiate Phase 2 Study in 4Q 2022 Excerpt from the Press Release: WATERTOWN, Mass.–(BUSINESS WIRE)–Enanta Pharmaceuticals, Inc. (NASDAQ: ENTA), a clinical-stage biotechnology company dedicated to creating novel, small molecule drugs for viral infections and liver…

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Acer Therapeutics and Relief Therapeutics Announce ACER-001 IND Submission for the Treatment of Maple Syrup Urine Disease

08/03/2022

Phase 2a trial initiation planned for the first half of 2023 subject to IND clearance and available capital Excerpt from the Press Release: NEWTON, Mass. and GENEVA, Switzerland, July 28, 2022 (GLOBE NEWSWIRE) — Acer Therapeutics Inc. (Nasdaq: ACER) (Acer) and its collaboration partner, RELIEF THERAPEUTICS Holding SA (SIX: RLF, OTCQB: RLFTF, RLFTY) (Relief), today…

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