Business
Marker Therapeutics Announces Completion of New Manufacturing Facility to Support Clinical Development of MultiTAA-Specific T Cell Therapy Product Candidates
-- Company expects to complete tech transfer and treat first patient with MT-401 manufactured in new cGMP facility in H1 2021 -- HOUSTON, Jan. 13, 2021
About this update from Marker Therapeutics, Inc.
[{"type":"text","content":"-- Company expects to complete tech transfer and treat first patient with MT-401 manufactured in new cGMP facility in H1 2021 --\n\n\nHOUSTON, Jan. 13, 2021 /PRNewswire/ -- Marker Therapeutics, Inc. (Nasdaq:MRKR), a clinical-stage immuno-oncology company specializing in the development of next-generation T cell-based immunotherapies for the treatment of hematological malignancies and solid tumor indications, today announced that it has completed the construction and qualification of its cGMP manufacturing facility in Houston, TX, located near the George Bush Intercontinental Airport. The facility will allow production of MultiTAA-specific T cell products according to U.S. Food and Drug Administration (FDA) guidelines and is designed to be scalable using modular processes. The Company has initiated the technology transfer process and expects the cGMP manufacturing facility to be fully operational in the first half of 2021. \n\n \n \n \n \n \n \n\n \n\"We are committed to the rapid advancement of our lead product candidate, MT-401, which, based on our novel MultiTAA-specific T cell technology, could potentially transform how patients with AML are treated,\" said Peter L. Hoang, President & CEO of Marker Therapeutics. \"With the recent initiation of our Phase 2 study in post-transplant AML, this new facility will assist with the timely manufacture of MT-401. In addition, the modular processes may enable cost-effective scalability, thereby supporting the manufacturing of MultiTAA-specific T cell products in future hematological and solid tumor trials, as well as the potential commercialization of our products.\"\nThe manufacturing of Marker's MultiTAA-specific T cell therapy for AML begins with collecting T cells from healthy donors. The T cells are subsequently sent to Marker's facility, where Marker isolates and selectively expands naturally occurring T cells that can recognize up to five unique tumor antigens. These tumor-specific T cells are then cryopreserved and shipped to clinical centers to be infused into the patient.\nPrior to completing the tech transfer and receiving regulatory approval for the cGMP manufacture, Marker will continue to manufacture its MultiTAA-specific T cell therapy at the Baylor College of Medicine to support the Company-sponsored AML trial.\nAbout MultiTAA-Specific T Cell TherapyMarker's Multi-Antigen...