Marker Therapeutics Announces Completion of New Manufacturing Facility to Support Clinical Development of MultiTAA-Specific T Cell Therapy Product Candidates
"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
The 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.
Prior 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
About MultiTAA-Specific T Cell Therapy
Marker's Multi-Antigen Targeted (MultiTAA) platform is a novel, non-genetically modified cell therapy approach that selectively expands tumor-specific T cells from a patient's blood capable of recognizing a broad range of tumor antigens. In early clinical trials, the multi-antigen approach has been well tolerated and shown to enhance tumor destroying capability and is one of the first therapies to consistently demonstrate epitope spreading – inducing the patient's own T cells to expand, potentially contributing to a lasting anti-tumor effect. Unlike other cell therapies which require pre-conditioning regimens and hospitalization, MultiTAA is designed to be administered in an outpatient setting.
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Forward-Looking Statement Disclaimer
This release contains forward-looking statements for purposes of the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. Statements in this news release concerning the Company's expectations, plans, business outlook or future performance, and any other statements concerning assumptions made or expectations as to any future events, conditions, performance or other matters, are "forward-looking statements." Forward-looking statements include statements regarding our intentions, beliefs, projections, outlook, analyses or current expectations concerning, among other things: our research, development and regulatory activities and expectations relating to our non-engineered multi-tumor antigen specific T cell therapies; the conduct and success of our clinical trials, as well as clinical trials conducted by our collaborators; the timing and success of the technology transfer process related to our planned manufacturing facility and the receipt of regulatory approval for the related cGMP; our manufacturing processes and our ability to use our current and planned manufacturing facilities to support clinical and commercial demand. Forward-looking statements are by their nature subject to risks, uncertainties and other factors which could cause actual results to differ materially from those stated in such statements. Such risks, uncertainties and factors include, but are not limited to the risks set forth in the Company's most recent Form 10-K, 10-Q and other
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