NCATS seeks to create hub for COVID-19 data; Regeneron reports preclinical data backing antiviral mAb cocktail
Regeneron’s preclinical data from antiviral COVID-19 mAbs, Cue test gets EUA and more
NIH’s NCATS has launched a collaborative aimed at facilitating data sharing among COVID-19 countermeasure developers.
The National Center for Advancing Translational Sciences (NCATS) said the National COVID Cohort Collaborative (NC3) seeks to create a centralized data hub to address the lack standardization in COVID-19 data collection and reporting. Through NC3, NCATS aims to accelerate the collection and analysis of clinical, laboratory and diagnostic data from hospitals and healthcare plans.
In viral countermeasure news, Regeneron Pharmaceuticals Inc. (NASDAQ:REGN) published a pair of Science papers describing the generation of and preclinical findings from its REGN-COV2 mAb cocktail. In one paper, the company reported its process for discovering neutralizing mAbs against SARS-CoV-2 -- including REGN-10933 and REGN-10987, the mAbs in REGN-COV2, which neutralized live SARS-CoV-2 with IC50 values of 0.037 and 0.042 nM, respectively.
Regeneron’s other study showed in cell culture that resistance-conferring mutations could arise after treatment with single neutralizing mAbs or combinations of mAbs with overlapping epitopes. By contrast, it observed no resistant mutants after treatment with REGN-COV2, a pair mAbs that do not have overlapping binding sites.
The papers come one week after the company began the first clinical trial of a COVID-19 antiviral mAb cocktail (see “Regeneron Pushes mAb Cocktail into Clinic”).
From the host-directed therapy front, Eli Lilly and Co. (NYSE:LLY) began a Phase III trial of Olumiant baricitinib, an oral inhibitor of JAK1 and JAK2, in hospitalized COVID-19 patients who have at least one marker of elevated inflammation but don’t require invasive mechanical ventilation at time of enrollment. The study data will complement those from NIH’s Adaptive COVID-19 Treatment Trial as well as investigator-initiated COVID-19 studies of the rheumatoid arthritis drug.
Meanwhile, Cue Health Inc. said FDA granted Emergency Use Authorization for its portable point-of-care COVID-19 diagnostic, which takes about 25 minutes to detect SARS-CoV-2 RNA from a nasal swab.
Separately, Almac Group Ltd., a CDMO, said it has received $288,000 via a grant from the COVID-19 Therapeutics Accelerator -- launched by the Bill & Melinda Gates Foundation, Wellcome Trust and Mastercard -- to conduct in Sub-Saharan Africa two clinical studies of an undisclosed therapeutic.
JAK-1 - Janus kinase-1
JAK-2 - Janus kinase-2