TCR² Therapeutics Announces 2021 Strategic Priorities and Milestones
January 08 2021 - 8:00AM
TCR2 Therapeutics Inc. (Nasdaq: TCRR), a clinical-stage
immunotherapy company with a pipeline of novel T cell therapies for
patients suffering from cancer, today announced its strategic
priorities and anticipated upcoming milestones.
“In the past twelve months, we validated the
clinical utility of our unique platform and demonstrated that our
TRuC-T cells consistently deliver solid tumor regression in
patients. Importantly, we are the first cell therapy company to
show clinical activity in ovarian cancer. We are pleased that the
significant progress across our entire pipeline positions us as a
leader in the solid tumor field,” said Garry Menzel, Ph.D.,
President and Chief Executive Officer of TCR2 Therapeutics.
“We believe 2021 will be another pivotal year for TCR2, ending with
three product candidates in clinical trials, most notably gavo-cel
in Phase 2 trials for multiple solid tumor indications. We
anticipate sharing our clinical progress at several medical
conferences. We will also be presenting preclinical data on new
autologous TRuC-T cell programs and, significantly, our allogeneic
TRuC-T cell program targeting mesothelin. Despite the challenges
posed by the ongoing pandemic, we remain focused on the execution
of our strategic priorities and bringing meaningful therapies to
cancer patients.”
2021 Strategic Priorities and
Milestones
Gavo-cel: lead TRuC-T cell
targeting mesothelin-positive non-small cell lung cancer, ovarian
cancer, malignant pleural/peritoneal mesothelioma, and
cholangiocarcinoma.
- Additional safety, efficacy and
translational data from Phase 1 dose escalation anticipated in
first half of 2021, with data from additional non-mesothelioma
patients
- Identification of recommended Phase
2 dose (RP2D) expected in 2021
- Initiation of Phase 2 expansion
cohort anticipated in 2021
TC-110: TRuC-T cell targeting
CD19-positive adult acute lymphoblastic leukemia and aggressive or
indolent non-Hodgkin lymphoma.
- Initial safety, efficacy and
translational data from Phase 1 dose escalation anticipated in
2021
Pipeline Expansion: TCR2 plans
to file an IND for a third TRuC-T cell program in 2021.
- Allogeneic TRuC-T
cells: preclinical data from an allogeneic TRuC-T cell
targeting mesothelin-positive solid tumors anticipated in 2021
- Autologous TRuC-T
cells: preclinical data from a TRuC-T cell targeting
CD70-positive solid tumors anticipated in 2021
Manufacturing: TCR2 continues
to focus on building manufacturing capacity in a capital efficient
manner.
- US Manufacturing
Capacity: Material for gavo-cel clinical trials expected
from Elevate Bio in 2021
- UK Manufacturing
Facility: Additional clinical T cell production
anticipated to come online by mid-2021
Cash Position and Financial
Guidance
TCR2 ended the third quarter of 2020 with $246.7
million in cash, cash equivalents, and investments. The Company
expects that its cash, cash equivalents and investments will fund
operating expenses and capital expenditure requirements into
2023.
About TCR2
Therapeutics
TCR2 Therapeutics Inc. is a
clinical-stage immunotherapy company developing a pipeline of novel
T cell therapies for patients suffering from solid tumors or
hematological malignancies. TCR2’s proprietary T cell
receptor (TCR) Fusion Construct T cells (TRuC®-T cells)
specifically recognize and kill cancer cells by harnessing
signaling from the entire TCR, independent of human leukocyte
antigens (HLA). In preclinical studies, TRuC-T cells have
demonstrated superior anti-tumor activity compared to chimeric
antigen receptor T cells (CAR-T cells), while secreting lower
levels of cytokine release. The Company’s lead TRuC-T cell product
candidate targeting solid tumors, gavo-cel, 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
cholangiocarcinoma. The Company’s lead TRuC-T cell product
candidate targeting hematological malignancies, TC-110, is
currently being studied in a Phase 1/2 clinical trial to treat
patients with CD19-positive adult acute lymphoblastic leukemia
(aALL) and with aggressive or indolent non-Hodgkin lymphoma (NHL).
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, future clinical and pre-clinical development
plans for the Company’s TRuC-T cells, their potential
characteristics, applications and clinical utility, the timing of
clinical trial data, future manufacturing capacity, and the
potential therapeutic applications of the Company’s TRuC-T cell
platform.
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, 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 CommunicationsTCR2 Therapeutics Inc.(617)
949-5667carl.mauch@tcr2.com
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