Stock Alert: Marker Therapeutics (MRKR)

(RTTNews) - Marker Therapeutics Inc. (MRKR) is trading at $2.91 in pre-market trading Tuesday, an increase of 8.18% from the previous closing price of $2.69, following news related to its planned phase II trial of MultiTAA T cell therapy in patients with post-transplant acute myeloid leukemia.

Last November, the Company had announced that its planned phase II trial of MultiTAA T cell therapy in patients with post-transplant acute myeloid leukemia was placed on hold by the FDA due to concerns about two reagents supplied by third-party vendors that are used in the MultiTAA-specific T cell manufacturing process.

Now that the Company has identified alternative suppliers, satisfying the FDA's request, the FDA has lifted the clinical hold permitting the initiation of its AML trial, beginning with a safety lead-in portion.

However, the FDA placed a partial clinical hold on the trial for the use of the MultiTAA-specific T cell product manufactured using one of the reagents supplied by the alternative supplier, until the final data and certificate of analysis for the reagent are reviewed and accepted by the regulatory agency.

Marker currently estimates that the alternative supplier will deliver the final reagent, along with the final data and certificate of analysis required by the FDA, by the end of the second quarter of 2020.

Commenting on the developments, Peter L. Hoang, President and CEO of Marker Therapeutics, said, "With a clear path identified for getting our study of MultiTAA-specific T cell therapy underway in patients with AML, we're focused on addressing the remaining requirements from the FDA and enrolling up to 20 clinical centers to conduct our Phase 2 trial."