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’ (NASDAQ: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.