- Danish biotech Evaxion Biotech ( EVAX ) announced Friday that the FDA greenlighted its request to conduct a Phase 2b trial for its cancer immunotherapy EVX-01 in combination with Merck’s ( MRK ) checkpoint inhibitor Keytruda targeting patients with metastatic melanoma.
- The American Depository Shares of Evaxion ( EVAX ) added ~22% in the pre-market trading in reaction.
- In November, the company submitted an Investigational New Drug Application (“IND”) in this regard, along with a Fast Track designation request to the regulator. On Dec. 22, the FDA responded with a decision to clear the IND. The company expects a reply to the Fast Track designation request in Q1 2023.
- The trial EVX-01 is anticipated to advance in the U.S., Europe, and Australia, with Merck ( MRK ) supplying its PD-1 inhibitor Keytruda.
- In September, Evaxion ( EVAX ) announced it enrolled the first patient in Australia for the EVX-01/ Keytruda global trial.
For further details see:
Evaxion jumps 22% as FDA clears mid-stage trial for melanoma candidate