TCR2 Therapeutics Inc. (Nasdaq: TCRR), a clinical-stage cell
therapy company with a pipeline of novel T cell therapies for
patients suffering from cancer, today announced that clinical and
translational data from the dose escalation portion of the
Company’s Phase 1/2 clinical trial of gavo-cel in patients with
treatment refractory mesothelin-expressing solid tumors will be
presented today at the American Association for Cancer Research
(AACR) Virtual Annual Meeting in an e-poster titled “Preliminary
Safety and Efficacy of gavocabtagene autoleucel (gavo-cel, TC-210),
a T Cell Receptor Fusion Construct (TRuC®), in Patients with
Treatment Refractory Mesothelin Overexpressing Solid Tumors.” In
addition, preclinical data from the Company’s autologous CD70 and
allogeneic mesothelin TRuC-T cells will be highlighted in e-posters
in the Adoptive Cell Therapy session at AACR.
“We are excited to be sharing with the
scientific community gavo-cel clinical and translational data,
which we believe underscore the benefit gavo-cel could provide to
treatment refractory solid tumor patients,” said Alfonso
Quintás-Cardama, Chief Medical Officer of TCR2 Therapeutics. “The
product attributes observed from our TRuC-T cell product candidate,
such as transduction efficiency, the TRuC-T cell naïve content, as
well as their expansion and persistence in vivo, are highly
encouraging as this degree of manufacturing consistency and
predictability will be critical to conduct the dose escalation
portion of our study and to allow an accurate identification of the
recommended Phase 2 dose. We are very pleased with the manageable
toxicity profile and clinical benefit the initial gavo-cel dose
levels have provided to patients with refractory solid tumors, in
particular because they exhausted all available therapeutic options
prior to enrolling in our study.”
The data reported in gavo-cel poster
presentation were from 8 treatment refractory mesothelin-expressing
solid tumor patients, 7 mesothelioma and 1 ovarian, that received a
single gavo-cel intravenous infusion at 5x107 cells/m2 or 1x108
cells/m2 either alone or following lymphodepletion with fludarabine
(30mg/m2/day x4) and cyclophosphamide (600mg/m2/day x3).
Translational data highlights from the poster include:
-
Transduction Efficiency: Achieved a median
transduction efficiency of 49% for gavo-cel T cell products
(TCP).
- CD4:CD8
Ratio: The median CD4:CD8 ratio in the gavo-cel T cell
products was 7.15.
- Memory
Phenotype: The median percentage of naïve TRuCs in the
TCPs was 30.45% (range, 14.1-56.2). The final TCPs show high TIM-3
positivity, variable PD-1 positivity and low LAG-3 positivity.
-
Expansion and Persistence: Peak gavo-cel expansion
(Cmax) occurred between days 7 and 23. Cmax increased when gavo-cel
was administered following lymphodepletion. The median peak
gavo-cel expansion was 811.9 copies/µg of genomic DNA (range, 520
to 5,901 copies/µg).
-
Cytokines: Cytokine elevations were detected in
all subjects, with minor changes in non-lymphodepleted patients.
The highest cytokine levels were observed in patients who
experienced grade 3 CRS (patients 2 and 7).
The e-poster presentation titled “Engineering
Off-the-shelf T Cell Receptor Fusion Construct (TRuC) T Cells” will
highlight allogeneic (off-the-shelf) TRuC-T cells targeting
mesothelin that utilized a CRISPR/Cas9 endonucleases approach,
yielding fully functional TRuCs that lack alloreactivity and
reduced risk of host rejection while maintaining upregulation of
activation markers, secretion of cytokines and clearance of tumor
cells comparable to autologous TRuC-T cells targeting
mesothelin.
The e-poster presentation titled “Discovery and
Preclinical Characterization of Fratricide-resistant TRuC-T Cells
Targeting CD70” will highlight fratricide-resistant CD70-directed
TRuC-T cells, which demonstrated an improved memory phenotype and
significant anti-tumor efficacy in multiple xenograft mouse models
with no evidence of in vivo fratricide.
“Our intent is to continue to build on the early
success of gavo-cel by making a significant investment in our solid
tumor pipeline,” said Garry Menzel, Ph.D., President and Chief
Executive Officer of TCR2 Therapeutics. “CD70 represents an
excellent target for our technology and has a broad addressable
patient population. In addition, we have also innovated an
allogeneic TRuC-T cell targeting mesothelin that will complement
our autologous programs. We look forward to providing further
updates on our solid tumor pipeline throughout the year.”
E-posters and poster videos presented at AACR
are available in the Presentations section of the Investors page of
the Company’s website at investors.tcr2.com.
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 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 and other product candidates, timing for
interim updates for the Company’s clinical trials and announcement
of additional preclinical data, manufacturing timing and capacity
for clinical trials and commercial operations, increased clinical
trial demand, timing of future IND filings and clinical development
plans, the development of the Company’s TRuC-T cells, their
potential characteristics, applications and clinical utility, 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, 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 CommunicationsTCR2 Therapeutics Inc.(617)
949-5667carl.mauch@tcr2.com
TCR2 Therapeutics (NASDAQ:TCRR)
Historical Stock Chart
From Aug 2024 to Sep 2024
TCR2 Therapeutics (NASDAQ:TCRR)
Historical Stock Chart
From Sep 2023 to Sep 2024