Marker Therapeutics announces first patient treated in off-the-shelf program

Marker Therapeutics (MRKR) announced that the first patient has been treated in the Company’s OTS program, with encouraging preliminary safety data. Marker is evaluating the safety and efficacy of escalating doses of MT-401, a multi-antigen recognizing T cell product targeting four antigens, as an OTS product in the Phase 1 RAPID study. The first study participant received the OTS product at the initial dose level and was monitored for 28 days. The therapy was well tolerated with no treatment-related adverse events. This observation is consistent with the favorable safety profile and tolerability previously reported for MAR-T cells. The OTS product will be initially tested in patients with acute myeloid leukemia or myelodysplastic syndromes, with the potential to be expanded to other indications. Marker has secured non-dilutive funding from the Food and Drug Administration, the National Institutes of Health Small Business Innovation Research program and the Cancer Prevention and Research Institute of Texas to support the clinical investigation of the OTS product. Using these allocated non-dilutive funds will allow the Company to proceed with the OTS program without affecting the Company’s runway and its efforts to advance its lead asset, MT-601, in the ongoing Phase 1 APOLLO study in patients with lymphoma. Marker recently reported an update from the APOLLO study highlighting a favorable safety profile and durable clinical responses. To facilitate the OTS program, the Company has established a cellular inventory from commercially available leukapheresis material that was carefully selected to cover a large patient population with partially human leukocyte antigen matched material. This approach has been validated and extensively tested in the clinic. Data from the ongoing RAPID trial will help inform future clinical developments of MAR-T cell products and guide their potential use as an OTS product in other indications.