As investors await phase II/III data from Gritstone Bio Inc.’s closely watched trial with Granite, an individualized neoantigen vaccine for microsatellite-stable colorectal cancer, Wall Street was busy handicapping odds for firm’s new approach, given the struggles by personalized methods generally.
Final phase II data showing improved survival rates in cervical cancer is giving Nykode Therapeutics ASA even more confidence in taking vaccine candidate VB10.16 further into oncology. The company had been considering targeting head and neck cancer for months. Now, with these new data, it said it’s fully behind focusing on PD-L1 patients with up to one prior line of systemic therapy.
The latest U.S. FDA emergency use authorizations to fall by the wayside, as COVID-19 continues to evolve, are the ones for the first Moderna Inc. and Pfizer Inc.-Biontech SE’s mRNA vaccines.
Combining the personalized cancer vaccine mRNA-4157 (V-940, Moderna Inc.) with Keytruda (pembrolizumab, Merck & Co. Inc.) significantly extended recurrence-free survival in patients with stage III/IV resected high-risk melanoma in the randomized phase II KEYNOTE-942/mRNA-4157-P201 trial. Compared to Keytruda alone, adding the vaccine cut the risk of recurrence or death by 44% 18 months after treatment, lead investigator Jeffrey Weber reported at the opening clinical trials plenary of the 2023 annual meeting of the American Association for Cancer Research (AACR).
On Vaccine Day, Moderna Inc. had to tell the world there weren’t enough flu cases to get a good reading in one of its two phase III vaccine studies. The northern hemisphere clinical trial of mRNA-1010, a seasonal quadrivalent vaccine, did not meet the statistical threshold because there were not enough sick participants to test to determine an interim efficacy analysis.
A live-attenuated vaccine targeting SARS-CoV-2 infection, which can be administered through the nose, has shown promise in preclinical animal studies carried out by researchers in Berlin. In an article published April 3, 2023, in Nature Microbiology, the authors reported that the COVID-19 vaccine candidate – sCPD9 – triggered the most robust immune response in a hamster model when compared with Biontech/Pfizer’s mRNA vaccine BNT162b2 and Ad2-Spike.
During the first round of discussion at its two-day hearing on a World Trade Organization proposal to expand the intellectual property (IP) waiver from COVID-19 vaccines to diagnostics and therapies, the U.S. International Trade Commission (USITC) got an earful from both sides of the debate.
CSPC Pharmaceutical Group Ltd.’s COVID-19 mRNA vaccine, SYS-6006, has been included for emergency use by the NMPA, the company said on March 22, marking the first domestically developed COVID-19 mRNA vaccine approved for use in China.
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.
Another step forward in the quest for an Epstein-Barr virus (EBV) vaccine took the form of Merck & Co. Inc.’s deal with Modex Therapeutics Inc., owned by Opko Health Inc., to advance MDX-2201 worldwide, an arrangement that brings $50 million up front for Opko plus as much as $872.5 million in milestone payments along with royalties.
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