Marker Therapeutics said that the US Food and Drug Administration (FDA) has cleared its investigational new drug (IND) application for MT-601 for the treatment of relapsed/refractory (r/r) non-Hodgkin lymphoma (NHL).

The IND is for the multi-tumor-associated antigen (multiTAA)-specific T cell product to be used in relapsed/refractory non-Hodgkin lymphoma patients who either failed or are not eligible to get anti-CD19 CAR T cell treatment.

According to Marker Therapeutics, MT-601 targets six antigens.

The approval of MT-601 IND paves the way for the drug candidate to be evaluated in a phase 1 trial.

Dr. Mythili Koneru — Marker Therapeutics Chief Medical Officer said: “This new clinical trial will build upon results that were observed in the Phase I/II TACTAL study conducted by BCM, which assessed the safety and efficacy of five-antigen-directed multiTAA-specific T cell product.

“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.

“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 these results, we believe that multiTAA-specific T cell products can be easily administered in an outpatient setting without hospitalization.”

Marker Therapeutics said that in the TACTAL study, patients were subject to treatment with five-antigen-directed multiTAA-T cell product.

On the basis of the safety profile seen with multiTAA-specific T cell therapies containing WT-1 in various cancer indications, the FDA approved the addition of WT-1 as the sixth tumor-associated antigen in the IND to the MT-601 product that will be used for the treatment of patients in the study sponsored by Marker Therapeutics.

Marker Therapeutics has been cleared by the FDA to begin its study at a dose level of 200 million cells per infusion compared to the dose range of 10-40 million cells per infusion used in the TACTAL study. As per the clinical-stage immuno-oncology company, this increase in the cell dose will be possible because of developing and adopting a nine-day manufacturing process, which is also said to expedite the time to treatment.

  Dr. Mythili Koneru, Marker Therapeutics, MT-601, Non-Hodgkin lymphoma, Oncology, US Food and Drug Administration, USA