Press Releases

Lenzilumab Treatment Response in Hospitalized COVID-19 Patients Correlates with C-Reactive Protein Levels

01/05/2022

Multi-variate analysis of LIVE-AIR Phase 3 data demonstrates that elevated baseline C-Reactive Protein (“CRP”) is the most predictive feature for progression to invasive mechanical ventilation (“IMV”) or death and may be a useful biomarker to guide therapeutic intervention Patients with baseline CRP<150 mg/L who received lenzilumab had a more than 2.5-fold higher likelihood to survive…

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Codex DNA Expands Catalog of COVID-19 Tools with Release of Full-Length Synthetic Genome for SARS-CoV-2 Omicron Variant

01/05/2022

Researchers around the world can utilize the synthetic genome to produce virus to test strain-specific diagnostics, monoclonal antibody treatments, small-molecule therapies, or new vaccines against the highly transmissible variant Excerpt from the Press Release: SAN DIEGO, Dec. 23, 2021 (GLOBE NEWSWIRE) — Codex DNA, Inc. (Nasdaq: DNAY), a pioneer in automated benchtop synthetic biology systems,…

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Ocugen Partner, Bharat Biotech, Announces Positive Immunogenicity and Safety Data From COVAXIN™ (BBV152), COVID-19 Candidate Vaccine, in Children 2 – 18 YEARS

01/04/2022

COVAXIN™ whole virus inactivated vaccine generated broad antibody response comparable to those seen in a large phase 3 trial in adults 18+ Adverse events were primarily mild, and no serious adverse events (SAEs) were noted Immunobridging trial demonstrated safety, reactogenicity and immunogenicity of COVAXIN™ in children from 2 years old and up No cases of myocarditis or…

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Akston Biosciences Announces Positive Top-Line Data From Phase II Study of COVID-19 Vaccine in the Netherlands

01/04/2022

Two 45 μg doses and single 90 μg of protein subunit vaccine AKS-452 were generally well-tolerated and showed robust neutralizing antibody titers Primary immunogenicity endpoints were met Vaccine is shelf stable for at least 6 months at 25° C (77° F) Phase II/III trial starting in India Excerpt from the Press Release: BEVERLY, Mass.–(BUSINESS WIRE)–Akston…

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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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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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