While Moderna Inc. CEO Stéphane Bancel was the one on the hot seat at a March 22 hearing before the U.S. Senate Health, Education, Labor and Pensions (HELP) Committee, biopharma profitability in general, and capitalism itself, came under fire as committee Chair Bernie Sanders (I-Vt.) railed about corporate greed in the sector.
The A’s have it but the B’s don’t in Moderna Inc.’s pivotal phase III study of mRNA-1010, a seasonal flu vaccine for adults living in the southern hemisphere. Interim results showed the vaccine achieved superiority on seroconversion rates for influenzas A/H3N2 and A/H1N1, superiority on geometric mean titer ratios for influenza A/H3N2 and noninferiority on geometric mean titer ratios for influenza A/H1N1. However, noninferiority was not met for the endpoints against the influenza B/Victoria- and B/Yamagata-lineage strains.
Harmonization and simplification won the day as the U.S. FDA’s Vaccines and Related Biological Products Advisory Committee (VRBPAC) looked toward the future of COVID-19 vaccines in the U.S. Jan. 26. The committee voted unanimously, 21-0, to recommend using the same strain composition for all COVID-19 vaccines available in the U.S., whether they’re used for primary doses or boosters. Such standardization also would align the composition of Novavax Inc.’s protein-based vaccine with that of the mRNA vaccines produced by Moderna Inc. and Pfizer Inc.-Biontech SE.
As the SARS-CoV-2 virus that’s responsible for COVID-19 continues to evolve across the world, a global response, similar to what’s used with influenza, would be ideal in evaluating and recommending vaccine strain composition changes from year to year. But “the current diversity of vaccine manufacturers and complexities in global supply of COVID-19 vaccines would make a globally coordinated, simultaneous vaccine composition evaluation and recommendation quite challenging,” the U.S. FDA said in its briefing document for the Jan. 26
meeting of the Vaccine and Related Biological Products Advisory Committee.
Now there are three. Moderna Inc. has posted strong phase III study data on its mRNA respiratory syncytial virus (RSV) vaccine, keeping pace with Pfizer Inc. and GSK plc’s candidates, which have May PDUFA dates. Moderna’s top-line results of the ConquerRSV pivotal efficacy study of mRNA-1345 show the vaccine hit its primary efficacy endpoints of 83.7% against RSV-associated lower respiratory tract disease in older adults.
Sen. Bernie Sanders (I-Vt.), the incoming chair of the U.S. Senate Health, Education, Labor and Pensions (HELP) Committee, penned a blistering letter that takes Moderna Inc. CEO Stéphane Bancel to task over the company’s plans to more than quadruple the U.S. list price of its COVID-19 vaccine once the government’s supply is depleted.
Once a rarity, billion-dollar deals are now coming fast and furious. Now three have appeared in only a few days. Gene therapy developer Voyager Therapeutics Inc. and Neurocrine Biosciences Inc. continued a longstanding partnership by agreeing to develop treatments for neurological diseases and for three new programs with rare CNS targets. Cytomx Therapeutics Inc. and Moderna Inc. entered a deal worth a potential $1.24 billion to Cytomx for generating and developing treatments in oncology and non-oncology. In the third deal, Royalty Pharma plc acquired an interest in Ionis Pharmaceuticals Inc.'s royalty in Biogen Inc.'s Spinraza (nusinersen) and Novartis AG's pelacarsen for up to $1.125 billion.
Vertex Pharmaceuticals Inc. has received clearance from the FDA for its IND application for VX-522, a messenger ribonucleic acid (mRNA) therapy targeted at treating the underlying cause of cystic fibrosis (CF).
Nona Biosciences Co. Ltd., a subsidiary of Harbour Biomed Therapeutics Ltd. launched in November to provide “idea to IND” services, has struck a deal with Moderna Inc. to develop nucleic acid-based immunotherapies. The candidates will be based on Harbour’s heavy chain only antibody discovery platform.
Nona Biosciences Co. Ltd., a subsidiary of Harbour Biomed Therapeutics Ltd. launched in November to provide “idea to IND” services, has struck a deal with Moderna Inc. to develop nucleic acid-based immunotherapies. The candidates will be based on Harbour’s heavy chain only antibody discovery platform.
