Alaunos Therapeutics to Present Early Data from TCR-T Library Phase 1/2 Trial at 2023 American Society of Clinical Oncology Annual Meeting
2023年5月26日 - 6:00AM
Alaunos Therapeutics, Inc. (“Alaunos” or the “Company”) (Nasdaq:
TCRT), a leading T-cell receptor (TCR) cell therapy company
advancing a clinical-stage pipeline of therapeutics for solid
tumors, today announced that the Company will present early
translational data from the first three patients treated in its
ongoing TCR-T Library Phase 1/2 trial at the 2023 American Society
of Clinical Oncology (ASCO) Annual Meeting taking place June 2-6,
2023, at the McCormick Place Convention Center in Chicago.
“Demonstrating our first objective clinical
response in solid tumors using non-viral TCR-T cell therapy
establishes proof-of-concept of our Sleeping Beauty cell
engineering platform’s potential to generate safe, persistent and
effective TCR-T therapies,” said Kevin S. Boyle, Sr., Chief
Executive Officer of Alaunos. “We believe our innovative non-viral
approach targeting high-frequency driver mutations is the most
promising approach for treating solid tumors. We are encouraged by
our ability to manufacture cell products with high viability,
purity and TCR positivity that have exhibited persistence and tumor
infiltration in patients. We remain confident in the promise of our
TCR-T platform to weaponize the immune system and revolutionize the
treatment of solid tumors.”
The poster will highlight early clinical and
translational data on the first three patients with refractory
solid tumors expressing KRAS or TP53 mutations who received
Sleeping Beauty TCR-T cells at one of two dose levels, DL1 (0.9 x
1010 TCR-T cells) and DL2 (6.4 x 1010 TCR-T cells and 5.8 x 1010
TCR-T cells). Manufactured TCR-T cells exhibited greater than 90%
TCR positivity, viability and purity, underscoring the ability of
the Company’s non-viral, universal manufacturing process to create
TCR-T cells in multiple indications with different TCRs.
Overall, the TCR-T cell therapy was observed to
be well-tolerated and presented a manageable safety profile, with
no dose-limiting toxicities or immune effector cell-associated
neurotoxicity syndrome observed and only one instance of grade
three cytokine release syndrome, which was resolved with
administration of tocilizumab.
Anti-tumor activity was seen in two patients, as
previously reported, including one patient with non-small cell lung
cancer (NSCLC) who achieved partial response with six-month
progression-free survival, and one colorectal cancer patient who
achieved a best overall response of stable disease at six weeks
with three-month progression-free survival. The third patient, a
60-year-old gentleman with advanced, chemotherapy-refractory stage
IV pancreatic cancer, experienced progressive disease. TCR
persistence and tumor infiltration were observed in patients at
last follow-up and out to seven months post-infusion in the NSCLC
patient.
Maria Pia Morelli, M.D., Ph.D., Assistant
Professor, Department of Gastrointestinal Medical Oncology at The
University of Texas MD Anderson Cancer Center and presenter of the
poster, added, “TCR-T cell therapy has shown early promise as a
potential cancer treatment. There remains a significant unmet
medical need for new, patient-specific therapies for people living
with difficult-to-treat solid tumor cancers. These early data are
encouraging as they showed an objective clinical response and
persistence alongside a favorable safety and tolerability profile
in patients who have not responded to prior lines of therapy. These
data support continued evaluation of driver-mutation reactive TCR-T
cells for the treatment of solid tumors, and we look forward to
continuing enrollment in the trial.”
The data will be presented during a poster
session at the 2023 ASCO Annual Meeting on Saturday, June 3, 2023,
between 8:00 – 11:00 a.m. CT. The full abstract is now available on
the ASCO conference website.
Alaunos expects to provide an interim data
update on multiple new patients in the third quarter of 2023 and
anticipates establishing a recommended Phase 2 dose by year-end
2023.
About the TCR-T Library Phase 1/2
TrialThe TCR-T Library Phase 1/2 trial is an open-label,
dose-escalation trial being conducted at MD Anderson. The trial is
actively enrolling patients with NSCLC, colorectal, endometrial,
pancreatic, ovarian and bile duct cancers that have a matching
human leukocyte antigen (HLA) whose tumors contain at least one of
the targeted driver mutations in KRAS, TP53 and EGFR. Additional
information about the trial is available at www.clinicaltrials.gov
using the identifier NCT05194735.
About Alaunos Therapeutics,
Inc.Alaunos Therapeutics is a leader in the science of
T-cell receptor (TCR) cell therapy working to revolutionize solid
cancer treatment and outcomes. The clinical-stage company’s TCR
T-cell therapy (TCR-T) is one of the most advanced TCR programs
targeting driver mutations in solid tumors with an ongoing Phase
1/2 trial of its TCR-T product candidates across six solid cancers.
Alaunos is powered by two proprietary platforms: its elegantly
efficient non-viral Sleeping Beauty cell engineering platform; and
its hunTR® discovery platform, which is expanding its
industry-leading library of TCRs against high-frequency driver
mutations. Alaunos is a part of an ongoing collaboration with the
National Cancer Institute (NCI), part of the National Institutes of
Health (NIH), working to advance the science of TCR therapy. For
more information, visit www.alaunos.com.
Forward-Looking Statements
DisclaimerThis 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 anticipated outcome of preclinical and clinical studies by the
Company or its third-party collaborators, the Company’s
manufacturing capabilities and the timing of the Company's research
and development programs, including the expected timeline for
enrolling and dosing patients, submitting and receiving approvals
on INDs and similar regulatory submissions and the timing and
forums for announcing data 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; the impacts
related to or resulting from recent bank failures and other
economic and industry volatility; the potential delisting of the
Company’s common stock from the Nasdaq Stock Market LLC, 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 periodic report
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
Media Contact:Heather Anderson6 Degrees
PRhanderson@6degreespr.com
Alaunos Therapeutics (NASDAQ:TCRT)
過去 株価チャート
から 4 2024 まで 5 2024
Alaunos Therapeutics (NASDAQ:TCRT)
過去 株価チャート
から 5 2023 まで 5 2024