Marker Therapeutics Inc. (NASDAQ: MRKR) has announced that the US FD has approved its Investigational New Drug application for MT -601 for treatment of refractory/relapsed non-Hodgkin lymphoma patients that are ineligible or have failed to get anti-CD19 CART cell treatment. MT-601 is a multi-tumor-associated antigen (multiTAA)-specific T cell candidate that targets six antigens.
The Phase I/II TACTAL research by BCM, which evaluated the efficacy and safety of a five-antigen-directed multiTAA-specific T cell product, will serve as a foundation for the new clinical study.
Observed CR rates in the study comparable to CD19 CAR-T therapies
Chief Medical Officer of Marker, Dr. Mythili Koneru, states, “In the TACTAL study, BCM observed long-term CR rates that were comparable to recently approved CD19 CAR-T therapies, even at very low cell doses. In addition, unlike CD19 CAR-T cell therapies, patients receiving multiTAA-specific T cell product had superior durability of response, without the severe toxicities that commonly occur with other adoptive cell therapies, such as cytokine release syndrome or neurotoxicity.”
Based on the findings, mutiTAA-specific cells can be administered in an outpatient setting. Patients in the TACTAL study received a five-antigen-directed multiTAA-T cell product as treatment. In addition, the FDA approved in the IND application the inclusion of WT-1 in the MT-601 product as a sixth tumor-associated antigen to be used in treating patients in the Marker-backed study.
FDA authorized the use of 200 million cells per infusion
Additionally, as opposed to the dosing interval of 10–40 million cells for each infusion utilized in the TACTAL study, the FDA has given Marker permission to start its investigation at a higher dosage of 200 million cells for infusion. Due to Marker’s creation and use of a 9-day production process that shortens the therapy duration, this increase in cell dosage will be attainable.
CEO and President Peter Hoang said, “FDA clearance of our IND for MT-601 is a significant milestone as we advance our pipeline in a number of Company-sponsored trials. We believe that MT-601, which targets six tumor-associated antigens highly expressed in lymphoma, has the potential to build upon results of the TACTAL study.”