The FDA has granted Orphan Drug Designation to Marker Therapeutics Inc's (NASDAQ:MRKR) MT-601, a multi-tumor-associated antigen (MultiTAA)-specific T cell product for pancreatic cancer.
- Following MT-401 for post-transplant acute myeloid leukemia (AML), MT-601 is Marker's second novel MultiTAA-specific T cell product to receive orphan drug designation and the first in a solid tumor indication.
- Marker developed MT-601, a new product targeting six tumor-associated antigens (PRAME, NY-ESO-1, Survivin, MAGE-A4, SSX2, WT1) highly expressed in pancreatic cancer.
- Related: Marker Therapeutics Secures $13.1M Grant To Support MultiTAA Cell Therapy Trial.
- The company plans to initiate a Phase 1 study of MT-601 administered with front-line chemotherapy to patients with locally advanced unresectable or metastatic pancreatic cancer.
- Marker designed the study to include an initial antigen escalation period followed by a dose-escalation period and enroll 20 – 25 patients.
- The company plans to file an Investigational New Drug Application (IND) for MT-601 for pancreatic cancer in 2022.
- Price Action: MRKR shares are up 12.3% at $0.94 during the premarket session on the last check Thursday.
