Researchers from Boston Children’s Hospital and Harvard Medical School reported the discovery and preclinical evaluation of SP1-77, a novel humanized monoclonal IgG-κ antibody targeting the receptor-binding-domain (RBD) of spike (S) glycoprotein of all SARS-CoV-2 variants.
Lenzilumab, Humanigen Inc.’s lead candidate, undershot statistical significance on the primary endpoint in the U.S. NIH-sponsored ACTIV-5/BET-B study of treating hospitalized COVID-19 patients. The Short Hills, N.J.-based company’s stock (NASDAQ:HGEN) crumpled in the wake of the results.
Seven fatalities that could be related to hemorrhagic events in Macrogenics Inc.’s phase II trial of the monoclonal antibody enoblituzumab for treating head and neck cancer has led to the study’s closure.
Cambridge Innovation Capital (CIC) has closed its oversubscribed Fund II at £225 million (US$287 million) and is moving from its previous model of open-ended investing to a traditional fixed-term venture capital fund. The money will be dedicated to spinouts from Cambridge University, with CIC investing in series A rounds, but also following on as companies mature and their capital requirements increase.
The release by the U.S. CMS of the final national coverage determination (NCD) for Biogen Inc.’s Alzheimer disease (AD) drug, Aduhelm (aducanumab), lit speculation on the meaning for others in the space. CMS is “still being conservative,” said Howard Fillit, co-founder and chief science officer of the Alzheimer’s Drug Discovery Foundation (ADDF). “We’re in a new era. It’s unprecedented that Medicare doesn’t pay for a drug that received approval from the FDA,” even though it was not a full but an accelerated clearance.
A team of researchers at the National Cheng-Kung University in Taiwan has created monoclonal antibodies (MAbs) that can neutralize the secretory glycoprotein chitinase-3-like-1 (CHI3L1) to stop cancer growth.
A Japanese study has shown that targeting the chemokine receptor CCR4 using treatment with the monoclonal antibody mogamulizumab (Poteligeo, Kyowa, Amgen) depleted immune regulatory T cells and significantly improved survival in a canine model of advanced prostate cancer.
Celltrion Inc.’s Regkirona (regdanvimab), a monoclonal antibody treatment for COVID-19, received its latest approval from the European Commission (EC), making it the first Mab developed in South Korea to be approved there. The green light for Celltrion Healthcare Hungary Kft., the Hungarian arm of Korean biopharmaceutical company Celltrion, is for the treatment of adults with COVID-19 aged 18 and over who do not require supplemental oxygen and who are also at increased risk of severe disease.
Brii Biosciences Ltd. shared interim data from a phase III trial of its neutralizing monoclonal antibody (mAb) combination therapy for SARS-CoV-2, BRII-196 and BRII-198, that showed a 78% reduction in the risk of hospitalization or death in patients receiving single dose of the cocktail.
