Moderna Plans Cancer Vaccine Filing as It Expands Beyond COVID
核心洞察
Moderna plans to file a biologics license application for intismeran (搜索), its individualized mRNA cancer vaccine developed with Merck (搜索), after the Phase 3 melanoma (搜索) trial met its primary and distant metastasis-free survival endpoints.
The roughly 1,100-patient blinded study compared intismeran (搜索) plus Keytruda with Keytruda alone, and Moderna says the results support a regulatory approval case.
Moderna is running three Phase 3 lung cancer (搜索) trials plus studies in renal cell, bladder, pancreatic and gastric cancer (搜索), and expects pivotal propionic acidemia (搜索) data by year-end.
Moderna executives outlined plans to file a biologics license application for intismeran (搜索), its individualized mRNA cancer vaccine partnered with Merck (搜索), following positive Phase 3 results in melanoma (搜索). Chief Development Officer David Berman said the trial met both its primary endpoint and a secondary endpoint of distant metastasis-free survival at the first interim analysis. The blinded, controlled study enrolled approximately 1,100 patients and compared intismeran plus Keytruda with Keytruda alone.
The program is being extended into other tumor types. Berman cited ongoing studies in lung cancer (搜索), renal cell carcinoma (搜索), bladder cancer (搜索), pancreatic cancer (搜索) and gastric cancer (搜索), including three Phase 3 lung cancer trials, one of which is an adjuvant study expected to complete randomization later this year. Moderna is also testing intismeran (搜索) in a Phase 3 trial in stage 1 lung cancer and a randomized Phase 2 trial in non-muscle-invasive bladder cancer, with the company's view that the treatment may be active without a PD-1 (搜索) inhibitor.
On manufacturing, CEO Stéphane Bancel said Moderna owns the proprietary process for selecting the 34 mutations in each individualized vaccine, with external partners supplying DNA sequencing data from healthy and cancer cells. He described production as a synthetic, cell-free liquid process, and said hospital operations, particularly rapid biopsy collection, may be the main bottleneck. Moderna and Merck (搜索) share costs equally and split remaining profit evenly. Separately, Moderna expects pivotal data for its propionic acidemia (搜索) program by year-end and is advancing an off-the-shelf Lynch syndrome (搜索) vaccine in Phase 1/2, shared-antigen cancer vaccines, a Phase 1 multiple myeloma (搜索) program combining three T-cell engagers, and an in vivo CAR-T effort.
Source: MarketBeat