TCR2 Therapeutics Announces Collaboration With Cell and Gene Therapy Catapult for the Manufacturing of its Novel T Cell Therapies for Cancer
CAMBRIDGE, Mass. and LONDON, March 26, 2019 /PRNewswire/ -- TCR(2) Therapeutics Inc. (Nasdaq: TCRR), a clinical-stage immunotherapy company developing the next generation of novel T cell receptor (TCR) therapies for patients suffering from cancer, today announced it has selected the advanced therapy medicinal products (ATMP) ecosystem in the United Kingdom (UK) to establish a site for global manufacturing systems and capabilities. TCR(2) will work with Cell and Gene Therapy Catapult (CGT Catapult) at their Stevenage manufacturing center to produce its novel TCR therapies based on the company's proprietary TRuC(TM) (TCR Fusion Construct) T cells.
"The agreement with CGT Catapult enables us to meet our immediate clinical trials needs and have the flexibility of both our own dedicated manufacturing space and access to an established supply chain at one of the world's premier centers for cell and gene therapy development," said Garry Menzel, Ph.D., President and Chief Executive Officer, TCR(2) Therapeutics. "Having these advanced manufacturing facilities already in place allows us to set up quickly and draw on the expertise and support functions provided by CGT Catapult and the wider life science ecosystem around Stevenage to produce our novel TRuC-T cell therapies and ensure sufficient supply for our clinical program. The UK government has shown tremendous leadership in cell therapy manufacturing and we are delighted to be working with such a talented pool of experts."
The CGT Catapult manufacturing center was established to allow companies developing cell and gene therapies to manufacture at scale, to Good Manufacturing Practice (GMP) standards. The center, underpinned by support from CGT Catapult experts across scientific research, manufacturing, supply, and regulation, provides the required capabilities for manufacture at high throughput in GMP environment, in terms of raw materials supply, quality control testing, cryostorage, logistics, track and trace, and integration into the wider supply chain. In September 2018, the center was awarded commercial licenses by the UK Medicines and Healthcare Regulatory Agency (MHRA) allowing the go-ahead for production of medicines for use in patients.
"We are delighted to welcome TCR(2) Therapeutics as the latest pioneering company to use the CGT Catapult manufacturing centre as its base for producing advanced therapies. It's fantastic that the appeal of our unique facilities - and the wider Stevenage biotech cluster - is being recognised beyond the UK, adding to the strong group of local companies already working with us. By next summer we will have doubled capacity to meet growing demand, further strengthening the UK's position as the world's most complete ecosystem for the development of cell and gene therapies," commented Keith Thompson, CEO, the CGT Catapult.
TCR(2) Therapeutics is the first U.S. company to establish manufacturing operations at the CGT Catapult manufacturing center in Stevenage, which was opened in April 2018 backed by more than £60 million of UK government investment as part of the Industrial Strategy Challenge Fund. TCR(2) joins advanced therapy companies Adaptimmune, Autolus, Cell Medica, and Freeline. The rapidly developing Stevenage cluster of cell and gene therapy currently includes development facilities for five cell and gene therapy companies, novel technology companies, as well as facilities established by international supply chain companies such as General Electric and Thermofisher. Capacity expansion at the manufacturing center is already under way to support strong growth in the cell and gene therapy industry.
About TCR(2) Therapeutics
TCR(2) Therapeutics Inc. is a clinical-stage immunotherapy company developing the next generation of novel T cell therapies for patients suffering from cancer. TCR(2)'s( )proprietary T cell receptor (TCR) Fusion Construct T cells (TRuC(TM)-T cells) specifically recognize and kill cancer cells by harnessing the entire TCR signaling complex independent of human leukocyte antigen (HLA). In preclinical studies, TRuC-T cells have demonstrated superior anti-tumor activity compared to chimeric antigen receptor T cells (CAR-T cells), while exhibiting lower levels of cytokine release. The Company's lead TRuC-T cell product candidate, TC-210, is currently being studied in a Phase 1/2 clinical trial to treat patients with mesothelin-positive non-small cell lung cancer (NSCLC), ovarian cancer, malignant pleural/peritoneal mesothelioma, and cholangiocarincoma. For more information about TCR(2), please visit www.tcr2.com.
About the Cell and Gene Therapy Catapult
The Cell and Gene Therapy Catapult was established as an independent centre of excellence to advance the growth of the UK cell and gene therapy industry, by bridging the gap between scientific research and full-scale commercialisation. With more than 180 experts focusing on cell and gene therapy technologies, it works with partners in academia and industry to ensure these life-changing therapies can be developed for use in health services throughout the world. It offers leading-edge capability, technology and innovation to enable companies to take products into clinical trials and provide clinical, process development, manufacturing, regulatory, health economics and market access expertise. Its aim is to make the UK the most compelling and logical choice for UK and international partners to develop and commercialise these advanced therapies. The Cell and Gene Therapy Catapult works with Innovate UK. For more information please visit ct.catapult.org.uk or visit http://www.gov.uk/innovate-uk.
Forward-Looking Statements Disclaimer
This press release contains forward-looking statements as defined in the Private Securities Litigation Reform Act of 1995, as amended. Forward-looking statements are statements that are not historical facts, and in some cases can be identified by terms such as "may," "will," "could," "expects," "plans," "anticipates," and "believes." These statements include, but are not limited to, statements regarding TCR(2)'s progress and timing of TCR(2)'s manufacturing programs. Although TCR(2)'s management team believes that the expectations reflected in such forward-looking statements are reasonable, investors are cautioned that forward-looking information and statements are subject to various risks and uncertainties, many of which are difficult to predict and generally beyond the control of TCR(2), that could cause actual results and developments to differ materially from those expressed in, or implied or projected by, the forward-looking information and statements. These risks and uncertainties include among other things, changes in TCR(2)'s operating plans that may impact its cash expenditures, the uncertainties inherent in research and development, process development, and manufacturing, as well as risk factors discussed or identified in the public filings with the Securities and Exchange Commission made by TCR(2), including those risks and uncertainties listed in TCR(2)'s most report on Form S-1 filed with the Securities and Exchange Commission. We are providing this information as of the date of this press release, and TCR(2 )does not undertake any obligation to update or revise the information contained in this press release whether as a result of new information, future events or any other reason.
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