- Marker Therapeutics, Inc. ( NASDAQ: MRKR ), a biotech focused on T cell-based immunotherapies, announced Tuesday that the FDA awarded a $2M grant to support its Phase 2 ARTEMIS trial for liquid tumor candidate MT-401 in patients with post-transplant acute myeloid leukemia (AML).
- MRKR shares added ~10% in the pre-market trading in reaction.
- MRKR said that the funding awarded under FDA’s Orphan Products Grants program would support the company’s treatment arm designed to test MT-401 in patients with post-transplant AML with minimal residual disease.
- In 2020, the FDA granted Orphan Drug Designation for MT-401 for treating AML following the allogeneic stem cell transplant. FDA’s Orphan Products Grants program has supported studies that led to the approval of over 70 products.
- A drug classified as a multi-tumor-associated antigen (MultiTAA) T-cell therapy, MT-401, is currently undergoing the multicenter ARTEMIS trial in patients with AML following an allogeneic stem-cell transplant in both the adjuvant and active disease setting.
For further details see:
Marker Therapeutics awarded $2M FDA grant for leukemia candidate