Marker Therapeutics gets FDA approval for MT-601 IND in r/r NHL


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.

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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.

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“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.

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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.

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