TCR² Therapeutics Receives FDA Orphan Drug Designation for Gavo-cel for the Treatment of Cholangiocarcinoma
September 02 2021 - 9:19AM
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 the U.S. Food
and Drug Administration (FDA) has granted the Company Orphan Drug
Designation (ODD) to gavo-cel for the treatment of
cholangiocarcinoma. New clinical data from the dose escalation
portion of the Phase 1/2 clinical trial of gavo-cel in patients
with treatment refractory mesothelin-expressing solid tumors will
be highlighted as part of an oral presentation at the European
Society for Medical Oncology on September 17 at 14:20 CEST (8:20AM
EST) and will include data for gavo-cel in malignant mesothelioma,
ovarian cancer and cholangiocarcinoma.
About Mesothelin-Expressing Solid
Tumors
Mesothelin is a cell-surface glycoprotein highly
expressed in a wide range of solid tumors, including malignant
pleural/peritoneal mesothelioma, ovarian cancer,
cholangiocarcinoma, breast cancer, pancreatic cancer and others.
Overexpression of mesothelin is associated with poorer prognosis in
some cancers due to its active role in both malignant
transformation and tumor aggressiveness by promoting cancer cell
proliferation, invasion, and metastasis. Of the wide range of solid
tumors expressing mesothelin, non-small cell lung cancer, ovarian
cancer, mesothelioma and cholangiocarcinoma represent a patient
population up to 80,000 annually in the United States alone.
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
cancer. 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 in cholangiocarcinoma and other indications,
timing of clinical data releases, future 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, 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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