- The U.S. Food and Drug Administration (FDA) granted fast track designation to Evaxion Biotech's ( EVAX ) personalized cancer immunotherapy EVX-01, in combination with Merck's ( NYSE: MRK ) Keytruda.
- In December 2022, Evaxion received FDA approval to proceed with a phase 2b trial of EVX-01 in combination with Keytruda to treat patients with metastatic melanoma — a type of skin cancer.
- Evaxion said that on Jan. 17, it received fast track designation for the vaccine candidate.
- "We are extremely pleased that our cancer vaccine candidate EVX-01 has received the FDA fast track designation, as it enables a potentially faster approval of the vaccine," said Evaxion CEO Per Norlén.
- The Denmark-based company noted that EVX-01 is a peptide-based cancer immunotherapy and is its most advanced clinical asset. Under the program, a unique drug is generated for each patient based on gene analysis of their tumors and on matching with their immune system.
- EVAX +14.94% to $1.84 premarket Jan. 19
For further details see:
Evaxion rises ~15% as personalized cancer immunotherapy gets FDA fast track status