March 5 COVID Quick Takes: Lilly mAbs clear EU hurdle; plus Adaptive authorization, Takeda pushes vaccine ahead in Japan, Aerpio therapy out of I-SPY
EMA’s CHMP recommended use of bamlanivimab from AbCellera Biologics Inc. (NASDAQ:ABCL) and Eli Lilly and Co. (NYSE:LLY), alone and together with Lilly’s etesevimab. The committee’s opinion backs use of bamlanivimab and the combo for confirmed COVID-19 in patients aged 12 years and up that do not require supplemental oxygen and who are at high risk of progressing to severe COVID-19.
FDA authorizes Adaptive T cell test for COVID-19
Adaptive Biotechnologies Corp. (NASDAQ:ADPT) received emergency use authorization (EUA) from FDA for its T-Detect test to detect recent or prior infection with SARS-CoV-2, with the goal of identifying individuals, including Long COVID patients, who cleared the virus without forming antibodies. The TCR sequencing-based test, which was developed via a partnership with Microsoft, launched Feb. 23 as a laboratory-developed test (LDT).
Takeda seeks Japan authorization of Moderna vaccine
Moderna Inc. (NASDAQ:MRNA) said that partner Takeda Pharmaceutical Co. Ltd. (Tokyo:4502; NYSE:TAK) submitted an NDA to Japan’s Ministry of Health, Labour and Welfare (MHLW) to import and distribute Moderna’s vaccine candidate against COVID-19, mRNA-1273 (TAK-919). The partners expect 50 million doses of the vaccine to be distributed beginning this half, pending licensure.
Aerpio’s razuprotafib dropped from I-SPY
Quantum Leap Healthcare Collaborative, the sponsor of the adaptive I-SPY COVID Trial, will not proceed with further testing of razuprotafib from Aerpio Pharmaceuticals Inc. (NASDAQ:ARPO). The collaborative said it dropped the therapy because of difficulty administering it in the setting of COVID-19, with 30% of patients discontinuing the agent due to disease-related hypotension. There was no indication that the therapy caused the hypotension that led to clinical decline in systolic blood pressure, according to QLHC.