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Product Development

Jan. 22 Quick Takes: CDC updates advice on COVID vaccine dosing; plus more vaccines for COVAX and RCC approval for Opdivo-Cabometyx and more 

Jan 22, 2021 | 10:27 PM GMT

CDC said the second dose of COVID-19 vaccines from Moderna Inc. (NASDAQ:MRNA) and partners BioNTech SE (NASDAQ:BNTX) and Pfizer Inc. (NYSE:PFE) can be administered up to six weeks after the first dose. The prior recommendation had been three weeks for Comirnaty from Pfizer and BioNTech and four weeks for the Moderna product, according to CDC. The agency also noted that the mRNA vaccines are not interchangeable with each other or with other COVID-19 vaccines.

Separately, BioNTech and Pfizer will supply COVAX with up to 40 million doses this year of Comirnaty at a not-for-profit price. The first deliveries are due this quarter to COVAX, a global partnership that aims to make it possible for at least 20% of the population of low- and middle-income countries to have access to COVID-19 vaccines.

Quick review of Opdivo-Cabometyx yields approval in RCC
FDA approved Opdivo nivolumab from Bristol Myers Squibb Co. (NYSE:BMY) and Cabometyx cabozantinib from Exelixis Inc. (NASDAQ:EXEL) to treat first-line advanced renal cell carcinoma. The approval comes about one month ahead of the application’s Feb. 20 PDUFA date; the agency reviewed the combo under its Real-Time Oncology Review pilot.

GSK stops ulcerative colitis trial of LAG3
GlaxoSmithKline plc (LSE:GSK; NYSE:GSK) discontinued a Phase II trial of GSK2831781 to treat active ulcerative colitis. GSK2831781 is an anti-LAG3 cell-depleting mAb derived from the IMP731 antibody from Immutep Ltd. (ASX:IMM; NASDAQ:IMMP). The Sydney-based company, which said the partners’ deal remains intact, is eligible for £54 million ($73 million) in remaining developmental milestones plus single-digit tiered royalties. Immutep, whose shares slipped 4% to $3.20 on Friday, said a Phase I trial of the compound in psoriasis showed preliminary evidence of efficacy.

baseclick’s SARS-CoV-2 mutation analysis
Using a sequencing method from Pacific Biosciences of California Inc. (NASDAQ:PACB), baseclick GmbH developed its Click Tech Single Strain Mutation Mapping Kit for SARS-CoV-2 to identify mutations in the virus’ genome section responsible for infectivity, disease progression and immunogenicity. The method can determine minor occurring mutations in virus populations that may become new dominant strains, as well as track all SARS-CoV-2 mutations within a COVID-19 patient over the course of the disease. 

TARGETS
LAG3 (CD223) – Lymphocyte-activation gene 3

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