"Phase 2 data is available. We have a factory that is almost finalized, and usually for cancer, those products are ready in six months versus 12 months. So that's why '25 is still possible," CEO Stephane Bancel said.
Moderna's personalized cancer vaccine, mRNA-4157, showed promising mid-stage results in combination with Merck's Keytruda for high-risk melanoma.
A Phase 3 trial is nearly fully enrolled, but discussions with the FDA for accelerated approval "haven't been productive."
"The company and its partner Merck will continue engaging with regulators on the program and remain focused on executing the Phase 3 trial," it said.
Moderna's personalized cancer vaccine, mRNA-4157, showed promising mid-stage results in combination with Merck's Keytruda for high-risk melanoma.
A Phase 3 trial is nearly fully enrolled, but discussions with the FDA for accelerated approval "haven't been productive."
"The company and its partner Merck will continue engaging with regulators on the program and remain focused on executing the Phase 3 trial," it said.
- Категория
- Онкодерматология
Комментариев нет.