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TCR² Therapeutics will add a second clean room to their manufacturing operations.
TCR² Therapeutics, a clinical-stage cell therapy company, announced on Nov. 1, 2021, that it would be expanding its manufacturing capacity by exercising an option on a second clean room at ElevateBio BaseCamp, a Cambridge, UK-based dedicated cell and gene therapy research, process development, and production center. This expansion complements TCR2’s buildout of clinical and commercial supply currently underway at its Rockville, MD, facility in the United States. The clean room addition will expand the company’s current good manufacturing (CGMP) capacity for clinical trials in 2022.
The timing of this capacity increase will coincide with a 2022 increase in demand from a Phase II clinical trial of TC-510, a mesothelin T-cell receptor (TCR) fusion construct (TRuC)-T cell therapy. According to a company press release, the TRuC platform is designed to recognize and kill cancer cells by harnessing signaling from the entire TCR, independent of human leukocyte antigens.
According to the release, this move is representative of TCR²’s long-term focus on developing clinical and commercial supply at the 85,000-ft² Rockville site. In conjunction with these plans, TCR² plans to cease manufacturing activities at the Cell and Gene Therapy Catapult in Stevenage, UK.
“This increase in [C]GMP manufacturing capacity at ElevateBio BaseCamp will ensure we are able to execute on the gavo-cel Phase [II] trial and the clinical plans for our next-generation TRuC-T cell products,” said Garry Menzel, president and CEO of TCR² Therapeutics, in the press release. “We are excited by the therapeutic potential of our lead clinical therapy gavo-cel and the emerging solid tumor pipeline reviewed recently at our R&D Day. Our strategy remains focused on continuous innovation providing multiple opportunities to save the lives of cancer patients.”
Source: TCR² Therapeutics