Alaunos Therapeutics Doses First Patient in TCR-T Library Phase 1/2 trial for the Treatment of Patients with Solid Tumors
May 02 2022 - 8:30AM
Alaunos Therapeutics, Inc. (“Alaunos” or the “Company”) (Nasdaq:
TCRT), a clinical-stage oncology-focused cell therapy company today
announced that the first patient has been dosed in its TCR-T
Library Phase 1/2 trial targeting KRAS, TP53, and EGFR mutations
across six solid tumor indications using the Company’s Sleeping
Beauty transposon/transposase technology.
“Dosing the first patient in our TCR-T Library
Phase 1/2 trial represents a significant accomplishment for
Alaunos. Our team has worked diligently to achieve this milestone
and bring our TCR-T cell therapy to cancer patients,” commented
Kevin S. Boyle, Sr., Chief Executive Officer of Alaunos. “We
believe that our adaptive trial design has the potential to allow
us to rapidly and cost effectively identify the recommended phase 2
dose and quickly advance studies in the most promising indications.
We look forward to an initial data readout in the second half of
this year.”
The Phase 1/2 study is being conducted at The
University of Texas MD Anderson Cancer Center and is an open label,
dose escalation study, with patients being treated in one of three
dose cohorts: 5x109, 4x1010, 1x1011 TCR-T cells. The trial is
enrolling patients with non-small cell lung, colorectal,
endometrial, pancreatic, ovarian, and bile duct cancers that have a
matching human leukocyte antigen (HLA) and hotspot mutation pairing
in Alaunos’ TCR-T library. The main study objectives are to define
the maximum tolerated dose, recommended phase 2 dose and safety
profile.
Carl June, M.D., Chairman of the Alaunos
Scientific Advisory Board added, “This is a significant
accomplishment as the first-in-human dosing of a patient
with Sleeping Beauty TCR-T cells. This approach targeting
shared driver mutations that are at the core of cancer provides
hope of meaningful clinical responses.”
For more information regarding the trial design
please see www.clinicaltrials.gov (identifier: NCT05194735).
About Alaunos
TherapeuticsAlaunos is a clinical-stage oncology-focused
cell therapy company, focused on developing T-cell receptor (TCR)
therapies based on its proprietary, non-viral Sleeping Beauty gene
transfer technology and its TCR library targeting shared
tumor-specific hotspot mutations in key oncogenic genes including
KRAS, TP53 and EGFR. The Company has clinical and strategic
collaborations with The University of Texas MD Anderson Cancer
Center and the National Cancer Institute. For more information,
please visit www.alaunos.com.
Forward-Looking Statements
Disclaimer This press release contains forward-looking
statements as defined in the Private Securities Litigation Reform
Act of 1995, as amended. Forward-looking statements are statements
that are not historical facts, and in some cases can be identified
by terms such as “may,” “will,” “could,” “expects,” “plans,”
“anticipates,” “believes” or other words or terms of similar
meaning. These statements include, but are not limited to,
statements regarding the Company's business and strategic plans,
the Company's cash runway, and the timing of the Company's research
and development programs, including the anticipated dates for
filing INDs, enrolling and dosing patients in and the expected
timing for announcing preclinical data and results from the
Company’s clinical trials. Although the management team of Alaunos
believes that the expectations reflected in such forward-looking
statements are reasonable, investors are cautioned that
forward-looking information and statements are subject to various
risks and uncertainties, many of which are difficult to predict and
generally beyond the control of Alaunos, that could cause actual
results and developments to differ materially from those expressed
in, or implied or projected by, the forward-looking information and
statements. These risks and uncertainties include, among other
things, changes in the Company’s operating plans that may impact
its cash expenditures; the uncertainties inherent in research and
development, future clinical data and analysis, including whether
any of Alaunos’ product candidates will advance further in the
preclinical research or clinical trial process, including receiving
clearance from the U.S. Food and Drug Administration or equivalent
foreign regulatory agencies to conduct clinical trials and whether
and when, if at all, they will receive final approval from the U.S.
Food and Drug Administration or equivalent foreign regulatory
agencies and for which indication; the strength and enforceability
of Alaunos’ intellectual property rights; and competition from
other pharmaceutical and biotechnology companies as well as risk
factors discussed or identified in the public filings with the
Securities and Exchange Commission made by Alaunos, including those
risks and uncertainties listed in the most recent Form 10-K filed
by Alaunos with the Securities and Exchange Commission. Alaunos is
providing this information as of the date of this press release,
and Alaunos does not undertake any obligation to update or revise
the information contained in this press release whether as a result
of new information, future events, or any other reason.
Investor Relations Contact:Alex
LoboStern Investor RelationsAlex.lobo@sternir.com
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