CAMBRIDGE, Mass. and
LONDON, March 26, 2019 /PRNewswire/
-- TCR2 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. TCR2 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™ (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,
TCR2 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 TCR2 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.
TCR2 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. TCR2 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 TCR2 Therapeutics
TCR2 Therapeutics Inc. is a
clinical-stage immunotherapy company developing the next generation
of novel T cell therapies for patients suffering from
cancer. TCR2's proprietary T cell
receptor (TCR) Fusion Construct T cells (TRuC™-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 TCR2, 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 TCR2's progress and timing of
TCR2's manufacturing programs. Although
TCR2'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
TCR2, 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
TCR2'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
TCR2, including those risks and uncertainties listed in
TCR2'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
TCR2 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.
View original
content:http://www.prnewswire.com/news-releases/tcr2-therapeutics-announces-collaboration-with-cell-and-gene-therapy-catapult-for-the-manufacturing-of-its-novel-t-cell-therapies-for-cancer-300817433.html
SOURCE TCR2 Therapeutics