TCR² Therapeutics Reviews Pipeline and Strategy at R&D Day
October 20 2021 - 6:45AM
TCR2 Therapeutics Inc. (Nasdaq: TCRR), a clinical-stage cell
therapy company with a pipeline of novel T cell therapies for
patients suffering from solid tumors, today unveiled new programs
and provided highlights from its emerging TRuC pipeline programs
during its first virtual R&D Day.
“At TCR2, our mission is to build the next great
cell therapy company in solid tumors based on the early success of
our mesothelin franchise and an emerging pipeline which will extend
our reach into new cancer patient populations and beyond,” said
Garry Menzel, Ph.D., President and Chief Executive Officer of
TCR2 Therapeutics. “Today we will review our narrowed focus on
solid tumors and unveil new strategies to potentially further
enhance the persistence and efficacy of our TRuC-T cells. In
addition, we will introduce compelling preclinical data for our
TRuC Tregs, which could expand our footprint into the autoimmune
disease setting. We believe that TCR2 is already helping to change
the treatment paradigm for patients with treatment-refractory solid
tumors and, through continued innovation, will progress our
re-prioritized pipeline to patients with a variety of unmet medical
needs.”
Pipeline Updates
Gavo-cel:
- TCR2 announced today the completion
of the 3-patient cohort at the new dose level 3.5A (3x108/m2
following lymphodepletion) using a split dosing approach. Two
patients were evaluable for safety. In both cases, gavo-cel was
well-tolerated with no patients experiencing on-target, off tumors
toxicities or Grade ≥3 cytokine release syndrome (CRS)
non-hematologic toxicities.
- TCR2 anticipates the identification
of the RP2D in 4Q21.
TC-110:
- TCR2 announced today that, in
alignment with its pipeline prioritization on solid tumors, the
Company has deprioritized the development of TC-110 for the
treatment of patients with CD19+ non-Hodgkin lymphoma or adult
acute lymphoblastic leukemia and plans instead to evaluate business
development options.
TC-510:
- TCR2 announced today the Company
anticipates the IND filing for its first TRuC-T cell enhanced with
a PD1xCD28 switch receptor to be in 1Q22.
TC-520:
- TCR2 announced today the selection
of its lead candidate targeting CD70 co-expressing an IL-15
enhancement as TC-520. In new preclinical data highlighted at the
R&D Day, TC-520 enhanced with membrane-bound IL-15 resulted in
a significant increase in TC-520 cells with a CD8+ naïve/T memory
stem cells phenotyope, improved autonomous persistence as well as
increased expansion following repeated stimulation with
CD70-expressing cancer cell lines.
- The Company anticipates initiating
IND-enabling studies for TC-520 with an indication focus on renal
cell carcinoma in 2022.
Allogeneic:
- TCR2 announced today new
preclinical data demonstrating allogeneic (off-the-shelf) TRuC-T
cells targeting mesothelin that utilized a CRISPR/Cas9
endonucleases approach and the use of fully human TCRγ/δ domains
reduced the risk of immunogenicity and host rejection, lacked
alloreactivity while maintaining clearance of tumor cells
comparable to autologous TRuC-T cells targeting mesothelin.
- TCR2 is currently evaluating the
combination of enhancements with allogeneic TRuC-T cells to
potentially improve persistence.
- The Company anticipates the
identification of a lead candidate for its allogeneic program in
2022.
TRuC Tregs:
- TCR2 announced today new
preclinical data demonstrating proof-of-concept for TRuC Treg cells
targeting HLA-A*02 for the prevention of Graft versus Host Disease
(GvHD). In in vitro and in vivo experiments, TRuC Tregs utilizing
the full TCR signaling complex promoted and stabilized Tregs by
suppressing the proliferation of mismatched effector cells and
inhibiting the production of cytokines in a dose dependent
manner.
- TCR2 plans to evaluate business
development options to enable the treatment of patients with GvHD
and other autoimmune diseases.
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.
TCR2
Therapeutics Conference Call and Webcast
TCR2 Therapeutics will host a conference call
and webcast on Wednesday, October 20 at 8:00am E.T. In order to
participate in the conference call, please dial 866-220-8062
(domestic) or 470-495-9169 (international) and refer to
confirmation number 1597681. The webcast and presentation will be
made available on the TCR2 Therapeutics website in the Investors
section under Events at investors.tcr2.com/events. Following the
live audio webcast, a replay will be available on the Company's
website for approximately 30 days.
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 TCR2’s
expectations for the Phase 1/2 clinical trial of gavo-cel; TCR2’s
expectations for the safety and efficacy of its product candidates
and enhancements, including gavo-cel, TC-510 and TC-520, compared
to current T-cell therapy approaches; TCR2’s expectations regarding
the timing of determining an RP2D for gavo-cel, TCR2’s expectations
regarding the timing of INDs, and TCR2’s expectations regarding the
estimated patient populations and related market opportunities in
gavo-cel’s, TC-510’s and TC-520’s targeted indications.
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 a trial; the possibility
that positive results from preclinical studies and correlative
studies may not necessarily be predictive of the results of TCR2’s
planned clinical trials, including the Phase 1/2 clinical trial of
gavo-cel; the risk that the results from the Phase 1/2 clinical
trial of gavo-cel will not support further development and
marketing approval; the risk that TCR2 may be unable to gain
approval of gavo-cel and its other product candidates on a timely
basis, if at all; the risk that TCR2 has over-estimated the
potential patient population for its product candidates, if
approved; the risk that the current COVID-19 pandemic will impact
TCR2’s clinical trials and other 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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