Dec. 3 Quick Takes: Moderna, NIH tout persisting neutralizing antibodies from COVID vaccine; plus Bayer, Galapagos, Braeburn, J&J and Equillium
Three-month immunity data for Moderna, NIH COVID vaccine
NIH reported in The New England Journal of Medicine that all 34 Phase I subjects who received two doses of 100 ug mRNA-1273 from Moderna Inc. (NASDAQ:MRNA) 28 days apart had detectable neutralizing antibodies 119 days after the first vaccination. Neutralizing geometric mean titers assessed in a plaque reduction assay were 430 in volunteers ages 18-55 at day 119 vs. 654 at day 43. In the ages 56-70 cohort, titers at day 119 were 269, down from 878 at day 43; and in participants ages ≥71, day 119 titers were 165 vs. 317 at the earlier time point.
The company, which on Monday applied for emergency use authorization, also reaffirmed that it expects to have 20 million vaccine doses available in the U.S. by year-end and 100-125 million doses globally available next quarter.
BLA submitted for first Genmab DuoBody based on Phase I data
The Janssen unit of Johnson & Johnson (NYSE:JNJ) submitted a BLA for amivantamab to treat patients with metastatic non-small cell lung cancer (NSCLC) with EGFR exon 20 insertion mutations whose disease has progressed on or after platinum-based chemotherapy. The BLA submission, which is based on data from the monotherapy arm of the Phase I CHRYSALIS study of the EGFR- and c-MET-targeting bispecific antibody, is the first for a product developed via the DuoBody platform from Genmab A/S (NASDAQ:GMAB; CSE:GMAB)...