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Marker Therapeutics Inc (NASDAQ:MRKR) announced it is restructuring its clinical programs and strategic prioritization of its multi-tumor associated antigen (multiTAA)-specific T cell product pipeline.
The company has prioritized MT-601 in chimeric antigen receptor (CAR) relapse patients with lymphoma.
The FDA cleared Marker's Investigational New Drug application for a Phase 1 trial to investigate MT-601 combined with first-line chemotherapy in patients with pancreatic cancer.
The clinical advancement of this multicenter study will be pending additional funding from non-dilutive sources.
In addition, the company reported a clinical update on the Phase 2 ARTEMIS study of MT-401 for acute myeloid leukemia (AML).
Obtaining timely consent and re-accessing HSCT donors for apheresis to manufacture MT-401 caused delayed patient accrual and eligibility issues.
Consequently, the rapid progression of the disease contributed to some patients withdrawing from the study before the administration of the study product.
Therefore, to streamline resources and reduce treatment time, Marker intends to focus on a ready-for-use product from commercially available leukapheresis material and will discontinue the patient-specific part (ARTEMIS) of the AML program.
"This approach is expected to not only reduce manufacturing costs, but also expedite time to treatment to as little as 72 hours. We are currently working to initiate the clinical study and anticipate that the first patient with AML will be treated with MT-401 manufactured from healthy donors in the second half of 2024," said Juan Vera, President and CEO of Marker Therapeutics.
Marker has secured non-dilutive funding to support the clinical investigation of a ready-for-use MT-401 product in AML patients. Using these allocated funds will allow the company to proceed with the ready-for-use program without affecting the ongoing Phase 1 APOLLO study and expects capital runway into Q4 of 2025.
Price Action: MRKR shares closed at $4.82 on Friday.
Posted In: MRKR
