RE:RE:mRNA vaccine company Phase 2 trial fails on wrong biomarkerIn May 2024 Moderna announced "Moderna’s foray into cancer is [being] led by mRNA-4157’s use in patients with high-risk melanoma and non-small cell lung cancer on top of Keytruda."
Moderna was planning on submitting the mRNA therapy for accelerated approval as a melanoma treatment, without recogizing that melanoma is a cancer that is neither rare or without an unmet treatment need, since there are multiple approved treatments for this disease. Now in September 13, 2024 - Moderna announced that while it is continuing development of its Merck & Co.-partnered cancer prospect mRNA-4157, Moderan has hit a regulatory obstacle on its Accelerated Approval plans. “Initial feedback from FDA has not been supportive of accelerated approval based on the current data,” Moderna said. Talks are ongoing but plans to seek approval may be put back until the partners have data from a “substantially enrolled” phase 3 trial in adjuvant melanoma, the company said.
https://www.fiercebiotech.com/biotech/moderna-targets-11b-rd-spending-cut-drops-5-programs-amid-profitability-pressures