TCR² Therapeutics Announces 2022 Strategic Priorities and Anticipated Milestones
January 10 2022 - 6:45AM
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, today announced its
strategic priorities and anticipated milestones for 2022.
“TCR2 is building a leading cell therapy company
for the treatment of cancer patients with solid tumors and we
believe 2022 will be a transformative year for the company. In our
upcoming Phase 2 clinical trial, gavo-cel efficacy will be
evaluated both as a monotherapy and in combination with key immune
checkpoint inhibitors through our partnership with Bristol Myers
Squibb. We believe gavo-cel has a promising competitive profile in
mesothelioma as well as other mesothelin-positive solid tumors,
such as ovarian cancer, where we were the first company to
demonstrate a RECIST clinical response with a cell therapy as a
single agent,” said Garry Menzel, Ph.D., President and Chief
Executive Officer of TCR2 Therapeutics. “In addition, we will
be generating clinical data from the next program in the pipeline,
TC-510, which is our first enhanced TRuC-T cell. In a
milestone-rich year, we will also provide several preclinical
updates on our emerging pipeline, including from a collaboration
with Arbor Biotechnologies to further advance our allogeneic TRuC-T
cells for the treatment of solid tumors.”
2022 Strategic Priorities and
Anticipated MilestonesGavo-cel: Lead
TRuC-T cell targeting mesothelin-positive non-small cell lung
cancer, ovarian cancer, malignant pleural/peritoneal mesothelioma,
and cholangiocarcinoma
- SRT identified recommended Phase 2
dose at 1x108 cells/m2
- Update on Phase 2 expansion cohort
initiation anticipated in 1H 2022, which is subject to Food and
Drug Administration (FDA) feedback on the clinical trial design and
clearance to initiate the Phase 2 expansion cohort
- Expanded and complete Phase 1
dataset on safety, efficacy and translational data anticipated in
1H 2022
- Initial data from Phase 2 expansion
cohort including safety, efficacy and translational data
anticipated in 2H 2022
TC-510: TRuC-T cell targeting
mesothelin-positive solid tumors
- IND filing and clearance
anticipated in 1H 2022
- Initial safety, efficacy and
translational data from Phase 1 dose escalation anticipated in 2H
2022
Pipeline Expansion:
Prioritization of enhanced TRuC-T cells in the Company’s growing
pipeline including both autologous and allogeneic programs in
2022
- Allogeneic TRuC-T
cells: Preclinical data from and selection of lead
allogeneic TRuC-T cell candidate anticipated in 2022
- Autologous TRuC-T
cells: Preclinical data from TRuC-T cells targeting novel
antigens and enhancements anticipated in 2022
Manufacturing: TCR2 continues to focus on
securing manufacturing capacity in a capital efficient manner
- Material for gavo-cel clinical trials expected to be
supplemented by ElevateBio in 2H 2022
- Phased buildout of commercial-scale
manufacturing center of excellence in Rockville, Maryland with
anticipated cGMP production in 2023
Cash Position and Financial Guidance
TCR2 ended the third quarter of 2021 with $295.7
million in cash, cash equivalents, and investments. The Company
expects that this will fund operating expenses and capital
expenditure requirements into 2024.
About TCR2
Therapeutics
TCR2 Therapeutics Inc. is a
clinical-stage cell therapy company developing a pipeline of novel
T cell therapies for cancer 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, TC-510 and TCR2’s other product candidates,
timing for interim updates for the gavo-cel clinical trial and
expectations regarding timing of initial data from the gavo-cel
Phase 2 study, expectations regarding the timing of TCR2’s TC-510
IND submission, Phase 1 clinical trial initiation and initial
clinical data, expectations regarding manufacturing plans and
capabilities, expectations regarding TCR2’s existing collaborations
and partnerships, expectations regarding regulatory approval
timelines, expectations regarding future clinical development,
partnering and commercialization plans, the development of TCR2’s
TRuC-T cells and pipeline development, their potential
characteristics, applications and clinical utility, the potential
therapeutic applications of TCR2’s TRuC-T cell platform, and
statements regarding TCR2’s financial position.
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
Contacts:
TCR2
Therapeutics
Carl MauchSenior Director, Investor Relations and Corporate
Communications(617) 949-5667carl.mauch@tcr2.com
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