Aug. 20 Quick Takes: Funding for Alzheon’s Alzheimer’s Phase III; plus Merck, FDA guidance, LumiraDx, RACE for Children, blood plasma and Novo-Evotec
Alzheon preps trial with $47M grant
NIH’s National Institute on Aging (NIA) will provide $47 million to Alzheon Inc. over five years to conduct a Phase III study of ALZ-801 to treat early Alzheimer’s disease in patients homozygous for APOE4. Alzheon had twice sought to raise money for the trial via IPOs that were later withdrawn. ALZ-801 is a prodrug of tramiprosate, which failed in Phase III testing to treat Alzheimer’s; a subsequent analysis of pooled data from two trials suggested the candidate improved cognition in a homozygous APOE4 subgroup (see “Alzheon: Data Justify Pursuit”).
Keytruda hits in 1L esophageal caner
Merck & Co. Inc. (NYSE:MRK) said an interim analysis showed Keytruda pembrolizumab met the primary endpoints in the Phase III KEYNOTE-590 trial. The anti-PD-1 mAb plus chemotherapy as a first-line treatment for esophageal cancer improved overall survival and progression-free survival vs. chemotherapy alone.
‘Mission critical’: FDA guidance on manufacturing, supply chain inspections
FDA issued guidance on Wednesday addressing questions on how agency inspections are being affected by COVID-19, what qualifies inspections as “mission critical” and how to implement changes to manufacturing facilities during the pandemic. The guidance follows a July announcement regarding FDA’s plans to gradually resume domestic inspections (see “Plans to Resume Domestic Inspections”).
Third COVID-19 antigen test comes to U.S. market
FDA authorized a third COVID-19 rapid, point-of-care antigen test to detect protein from SARS-CoV-2. The test, developed by LumiraDx UK Ltd., is authorized for use on nasal swabs collected from individuals suspected of having COVID-19 by their healthcare provider, within 12 days of symptom onset. Assistant Secretary for Health and COVID-19 Testing Coordinator Brett Giroir said LumiraDx’s technology has "almost everything we hope for in new testing platforms," including built-in digital connectivity and flexibility to perform assays for other disease indicators such as inflammatory markers. HHS has spotlighted rapid antigen tests as part of the solution to COVID-19 testing backlogs (see “Point-of-Care, Pooled Tech as Way Out of Testing Crunch”).
Pediatric research now required for certain cancer candidates
The Research to Accelerate Cures and Equity (RACE) for Children Act was implemented on Tuesday. The law, which was passed as part of the FDA Reauthorization Act of 2017, requires sponsors developing molecularly targeted therapies for adult cancers to conduct trials in pediatric cancers that share the targeted molecular characteristics (see “FDA’s Pediatric Target Picks”).
Collins, Fauci, Lane push back on plasma EUA
NIH Director Francis Collins and NIAID’s H. Clifford Lane and Anthony Fauci persuaded FDA not to grant Emergency Use Authorization for blood plasma to treat COVID-19, arguing the data are too weak, The New York Times reported Wednesday citing Lane. The National Institute of Allergy and Infectious Diseases did not respond to a request for comment from BioCentury.
Evotec, Novo pair up to tackle kidney disease
Evotec SE (Xetra:EVT) and Novo Nordisk A/S (CSE:NOVO B; NYSE:NVO) partnered to develop modality-agnostic therapies to treat chronic kidney disease against novel targets identified with molecular datasets from thousands of patients. The two companies will collaborate on drug discovery and preclinical development, after which Novo will be responsible for clinical development and commercialization. Evotec will receive an undisclosed up front payment and research funding, and is also eligible for tiered royalties and more than €150 million in milestones per product.
APOE4 – Apolipoprotein E epsilon 4