TCR² Therapeutics Announces Expansion of U.S. Manufacturing Capacity
02 November 2021 - 7:05AM
TCR2 Therapeutics Inc. (Nasdaq: TCRR), a clinical-stage cell
therapy company with a pipeline of novel T cell therapies for
cancer patients suffering from solid tumors, announced today the
expansion of its manufacturing capacity by exercising an option on
a second clean room at ElevateBio BaseCamp which adds to the
buildout of clinical and commercial supply currently underway at
its Rockville, MD, facility.
The timing of the additional supply at
ElevateBio BaseCamp aligns with an anticipated 2022 increase in
demand from the Phase 2 clinical trial of gavo-cel for
mesothelin-expressing solid tumors as well as the start of a Phase
1 clinical trial for TC-510, a mesothelin TRuC-T cell enhanced with
a PD1xCD28 switch. The long-term focus for TCR2 clinical and
commercial supply remains on developing the 85,000 square foot
Rockville facility as its manufacturing center of excellence in the
U.S. In connection with this expansion, TCR2 proposes to cease
manufacturing activities at the Cell and Gene Therapy Catapult (CGT
Catapult) in Stevenage, UK.
“This increase in cGMP manufacturing capacity at
ElevateBio BaseCamp will ensure we are able to execute on the
gavo-cel Phase 2 trial and the clinical plans for our
next-generation TRuC-T cell products,” said Garry Menzel, President
and Chief Executive Officer of TCR2 Therapeutics. “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”.
About
TCR2
Therapeutics
TCR2 Therapeutics Inc. is a
clinical-stage cell therapy company developing a pipeline of novel
T cell therapies for patients suffering from solid
tumors. The company is focused on the discovery and
development of product candidates against novel and complex targets
utilizing its proprietary T cell receptor (TCR) Fusion
Construct T cells (TRuC®-T cells). The TRuC platform is
designed to specifically recognize and kill cancer cells by
harnessing signaling from the entire TCR, independent of human
leukocyte antigens (HLA). For more information about TCR2, please
visit www.tcr2.com.
Forward-looking
Statements
This press release contains forward-looking
statements and information within the meaning of the Private
Securities Litigation Reform Act of 1995 and other federal
securities laws. The use of words such as "may," "will," "could",
"should," "expects," "intends," "plans," "anticipates," "believes,"
"estimates," "predicts," "projects," "seeks," "endeavor,"
"potential," "continue" or the negative of such words or other
similar expressions can be used to identify forward-looking
statements. These forward-looking statements include, but are not
limited to, express or implied statements regarding the therapeutic
potential of gavo-cel and TCR2’s emerging solid tumor pipeline,
expectations regarding increased demand for the TCR2’s product
candidate trials, the proposed consolidation of manufacturing in
the US and closure of the manufacturing suite in Stevenage, UK and
related costs, expectations regarding manufacturing plans and
capabilities, future clinical development and commercialization
plans, and the development of the TCR2’s TRuC-T cells.
The expressed or implied forward-looking
statements included in this press release are only predictions and
are subject to a number of risks, uncertainties and assumptions,
including, without limitation: uncertainties inherent in clinical
studies and in the availability and timing of data from ongoing
clinical studies; whether interim results from a clinical trial
will be predictive of the final results of the trial; whether
results from preclinical studies or earlier clinical studies will
be predictive of the results of future trials; the expected timing
of submissions for regulatory approval or review by governmental
authorities, including review under accelerated approval processes;
orphan drug designation eligibility; regulatory approvals to
conduct trials or to market products; TCR2’s ability to maintain
sufficient manufacturing capabilities to support its research,
development and commercialization efforts, including TCR2’s ability
to secure additional manufacturing facilities; whether TCR2's cash
resources will be sufficient to fund TCR2's foreseeable and
unforeseeable operating expenses and capital expenditure
requirements, the impact of the COVID- 19 pandemic on TCR2’s
ongoing operations; and other risks set forth under the caption
"Risk Factors" in TCR2’s most recent Annual Report on Form 10-K,
most recent Quarterly Report on Form 10-Q and its other filings
with the Securities and Exchange Commission. In light of these
risks, uncertainties and assumptions, the forward-looking events
and circumstances discussed in this press release may not occur and
actual results could differ materially and adversely from those
anticipated or implied in the forward-looking statements. You
should not rely upon forward- looking statements as predictions of
future events. Although TCR2 believes that the expectations
reflected in the forward-looking statements are reasonable, it
cannot guarantee that the future results, levels of activity,
performance or events and circumstances reflected in the
forward-looking statements will be achieved or occur.
Moreover, except as required by law, neither
TCR2 nor any other person assumes responsibility for the accuracy
and completeness of the forward-looking statements included in this
press release. Any forward-looking statement included in this press
release speaks only as of the date on which it was made. We
undertake no obligation to publicly update or revise any
forward-looking statement, whether as a result of new information,
future events or otherwise, except as required by law.
Investor and
Media Contact:
Carl MauchDirector, Investor Relations and
Corporate Communications (617) 949-5667carl.mauch@tcr2.com
TCR2 Therapeutics (NASDAQ:TCRR)
Historical Stock Chart
From Jun 2024 to Jul 2024
TCR2 Therapeutics (NASDAQ:TCRR)
Historical Stock Chart
From Jul 2023 to Jul 2024