News & Updates

EVUSHELD long-acting antibody combination retains neutralizing activity against Omicron variant in independent FDA study

12/23/2021

Only antibody authorized in the US for pre-exposure prophylaxis of COVID-19 Excerpt from the Press Release: WILMINGTON, Del.–(BUSINESS WIRE)–AstraZeneca’s EVUSHELD (tixagevimab co-packaged with cilgavimab), a long-acting antibody combination for the prevention of COVID-19, retained neutralizing activity against the Omicron SARS-CoV-2 variant (B.1.1.529), according to new preclinical data. In this study,EVUSHELD’s Inhibitory Concentration 50 (IC50), a measure…

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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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Artax Biopharma Announces First-in-Human Dosing in Phase 1 Clinical Trial for AX-158, Company’s First-in-Class Oral Immunomodulator to Treat T Cell-Mediated Diseases

12/22/2021

The Phase 1 Trial, Expected to Conclude in 2022, Will Evaluate Safety, Exposure, and Pharmacokinetics of AX-158 in Healthy Volunteers AX-158, a Novel, Oral Small Molecule Immunomodulating Agent for the Treatment of T Cell- Mediated Diseases, Selectively Modulates T Cell Responses without Suppression of Immune System Function Excerpt from the Press Release: CAMBRIDGE, Mass., Dec. 15,…

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Cullinan Oncology Announces Updated Phase 1/2a Data for CLN-081 in NSCLC EGFR Exon 20 Patients

12/21/2021

CLN-081 continues to demonstrate a differentiated clinical profile at the recommended Phase 2 dose of 100mg BID Continued high response rate with favorable safety and tolerability profile observed in heavily pre-treated patients at 100mg BID Encouraging durable responses and progression free survival at 100mg BID Excerpt from the Press Release: CAMBRIDGE, Mass., Dec. 16, 2021…

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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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Rubius Therapeutics to Highlight the Power of its RED PLATFORM®, Significant Advances Across Red Cell Therapeutic Oncology Pipeline and New Type 1 Diabetes Program at Platform and Pipeline Day

12/21/2021

Highly Versatile and Programmable RED PLATFORM Enables Multiple Modalities to Target Different Immune Pathways Across a Range of Diseases Demonstrated Tolerance Induction with Bystander Suppression in Type 1 Diabetes Preclinical Program with Findings Translatable to Multiple T Cell-Mediated Autoimmune Diseases Advancing Next-Gen Artificial-Antigen Presenting Cells (aAPCs) with Loadable MHC Class 1 Platform, Enabling Presentation of…

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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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uniQure Announces Clinical Update on First Patients in Phase I/II Clinical Trial of AMT-130 Gene Therapy for the Treatment of Huntington’s Disease

12/20/2021

~ Treatment was well tolerated with no significant safety issues related to AMT-130 in first two treated patients through one year of follow-up ~ ~ Neurofilament Light Chain (NfL) rose as expected immediately following surgery andreturned to baseline in treated patients ~ ~ A total of 19 patient procedures have been performed in the U.S.…

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