Marker Therapeutics Shares Jump 60 Percent As FDA Announced Clearance To Blood Cell Cancer Study

The U.S. Food and Drug Administration (FDA) announced clearance to Marker Therapeutics’ MRKR Investigational New Drug (IND) application for MT-601 for the treatment of patients with relapsed/refractory non-Hodgkin lymphoma.

The Phase 1 trial is designed to evaluate MT-601 on relapsed/refractory non-Hodgkin lymphoma patients who have failed CD19 CAR-T therapy, or those who are ineligible for treatment with those therapies.

The company indicated that the Phase 1 trial 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.

Peter L. Hoang, President and Chief Executive Officer, commented: ”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. We look forward to initiating our Company-sponsored Phase 1 study next year.”

Price Action : Marker Therapeutics shares are trading around 60 percent higher on Thursday during after-hours session.