Industry News

Glycomine Announces First Dosing in Phase 1 Clinical Study of GLM101, a Potential Treatment for PMM2-CDG

12/24/2021

Excerpt from the Press Release: SAN CARLOS, Calif.–(BUSINESS WIRE)–Glycomine, Inc., a biotechnology company focused on developing new therapies for orphan diseases, today announced that the company has received U.S. Food and Drug Administration (FDA) clearance of an Investigational New Drug (IND) application for GLM101 for the treatment of PMM2-CDG and has initiated dosing healthy volunteers…

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Apnimed Announces Dosing of First Patient in Phase 2 MARIPOSA Confirmatory Trial of AD109, a Potential Nighttime Oral Treatment for Obstructive Sleep Apnea (OSA)

12/24/2021

– Study to Inform Phase 3 Program Design of AD109 and Advance Program for AD504 – Topline Results Expected Mid-2022 Excerpt from the Press Release: CAMBRIDGE, Mass.–(BUSINESS WIRE)–Apnimed, a clinical-stage pharmaceutical company focused on developing oral pharmacologic treatments to address obstructive sleep apnea (OSA) and related disorders, today announced the dosing of the first patient in the…

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Notable Presents Clinical Validation Data from Two Phase 2 Trials in Adult and Pediatric Acute Myelogenous Leukemia at the 63rd American Society of Hematology (ASH) Annual Meeting

12/23/2021

-Studies demonstrate high correlation between predicted response by Notable’s predictive precision medicines platform and actual clinical response, short-term and at one year- -Interim analyses of studies with MD Anderson Cancer Center and Texas Children’s Hospital investigators corroborate platform prediction data from Standford University collaboration- Excerpt from the Press Release: FOSTER CITY, Calif.–(BUSINESS WIRE)–Notable Labs, Inc.…

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Vaxart to Test Cross-Reactivity of its COVID-19 Oral Tablet Vaccine Against Omicron

12/22/2021

Cross-reactivity will be assessed using samples from Phase II clinical participants and in a parallel animal challenge study Oral tablet’s immunogenicity profile suggests it may provide cross-protection against SARS-CoV-2 variants, including Omicron Excerpt from the Press Release: SOUTH SAN FRANCISCO, Calif., Dec. 16, 2021 (GLOBE NEWSWIRE) — Vaxart, Inc. (NASDAQ: VXRT) said today it plans to…

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Kura Oncology Doses First Patient in Phase 1/2 Clinical Trial of Tipifarnib in Combination with Tipifarnib in Head and Neck Squamous Cell Carcinoma

12/22/2021

– Preclinical data suggest HRAS and PI3Kα are co-dependent oncogenes in HNSCC – – Combination has potential to address up to 50% of patients with HNSCC – – Initial cohort comprised of patients with PIK3CA-dependent HNSCC – SAN DIEGO, Dec. 16, 2021 (GLOBE NEWSWIRE) —  Kura Oncology, Inc. (Nasdaq: KURA), a clinical-stage biopharmaceutical company committed…

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Forma Therapeutics’ Investigational Olutasidenib in Combination with Azacitidine Yields Durable Complete Remission in Patients with mIDH1 Acute Myeloid Leukemia

12/21/2021

First Phase 2 combination trial results presented in oral session at 2021 ASH Annual Meeting Olutasidenib with azacitidine well tolerated with a safety profile largely consistent with olutasidenib alone ​ Molecular characteristics of olutasidenib monotherapy response reported in ASH poster presentation Excerpt from the Press Release: WATERTOWN, Mass.–(BUSINESS WIRE)–Dec. 16, 2021– Forma Therapeutics Holdings, Inc.…

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Seres Announces Preliminary SER-287 Phase 2b ECO-RESET Study Microbiome Data Analysis

12/20/2021

– Microbiome data demonstrate the successful engraftment of SER-287 – – Microbiome assessments suggest potential for biomarker-based patient selection – – Company continues to evaluate SER-287 study data, and available preliminary SER-301 Phase 1b study clinical and microbiome data, to inform plans for continued development in ulcerative colitis – Excerpt from the Press Release: CAMBRIDGE,…

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ENHERTU® (fam-trastuzumab deruxtecan-nxki) Additional Analyses Further Reinforce Ground-breaking Efficacy in Patients With HER2-positive Metastatic Breast Cancer

12/16/2021

New DESTINY-Breast03 data presented at SABCS 2021 showed AstraZeneca and Daiichi Sankyo’s ENHERTU demonstrated a similar benefit in patient subgroups, including in patients with stable brain metastases, versus T-DM1 Excerpt from the Press Release: WILMINGTON, Del.–(BUSINESS WIRE)–New results from the DESTINY-Breast03 Phase III trial showed that ENHERTU® (fam-trastuzumab deruxtecan-nxki)demonstrated a higher progression-free survival (PFS) and objective…

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Carrick Therapeutics Presents Encouraging Clinical Data for Samuraciclib (CT7001) at the 2021 San Antonio Breast Cancer Symposium

12/15/2021

Excerpt from the Press Release: DUBLIN, Ireland and BOSTON, Mass., Dec. 09, 2021 (GLOBE NEWSWIRE) — Carrick Therapeutics, an oncology-focused biopharmaceutical company discovering and developing highly differentiated therapies, today at the 2021 San Antonio Breast Cancer Symposium (SABCS), presented encouraging clinical data on samuraciclib (CT7001), an oral and first-in-class inhibitor of CDK7, that support its…

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BeiGene Presents Results from Phase 3 Trial of Tislelizumab in Nasopharyngeal Cancer at ESMO Immuno-Oncology Congress 2021

12/15/2021

In RATIONALE 309, tislelizumab in combination with chemotherapy significantly prolonged progression-free survival for patients, with survival benefit observed across patient subgroups The safety profile of the combination was consistent with known risks of each treatment agent Following the positive topline at an interim analysis, a supplemental biologics license application in this indication is currently under…

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