Alaunos Therapeutics Announces Early Clinical Data Showing Objective Clinical Response Using its TCR-T Cell Therapy
September 06 2022 - 8:00AM
Alaunos Therapeutics, Inc. (“Alaunos” or the “Company”) (Nasdaq:
TCRT), a clinical-stage oncology-focused cell therapy company,
today announced early clinical findings from its ongoing TCR-T
Library Phase 1/2 trial.
“We are excited to announce early findings from
our TCR-T Library trial. This is the first time that an objective
clinical response has been observed in a solid tumor cancer in
connection with non-viral TCR-T cell therapy,” said Kevin S. Boyle,
Sr., Chief Executive Officer of Alaunos. “We believe this
reinforces our approach targeting shared tumor-specific hotspot
mutations using our non-viral Sleeping Beauty technology. We look
forward to presenting additional details at the CICON conference on
September 30.”
The TCR-T Library Phase 1/2 trial is an open
label, dose escalation study being conducted at The University of
Texas MD Anderson Cancer Center. 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 library.
The first patient dosed was diagnosed with non-small cell lung
cancer with a KRAS G12D mutation, matching one of the ten TCRs
within the Company’s TCR library. The patient received TCR-T cells,
which were produced using Sleeping Beauty at the Company’s in house
cGMP manufacturing facility. The patient had a confirmed objective
partial response. The Company has dosed a second patient in the
study, diagnosed with colon cancer, who has been treated at the
second dose level and has cleared the 28-day safety window.
“While cell therapies have demonstrated success
in hematological cancers, there remains a significant unmet medical
need for effective and cost-efficient cell therapies for patients
with solid tumors, which account for nearly 90% of all cancer
diagnoses. These early clinical findings show the potential for the
first time that we may be able to use a non-viral TCR-T cell
therapy to achieve measurable regression in solid tumors,” added
Marcelo V. Negrao, MD, Department of Thoracic-Head & Neck
Medical Oncology, Division of Cancer Medicine at MD Anderson. “We
are encouraged by these findings, and we look forward to continuing
enrollment in the study.”
Data is scheduled to be presented during a
proffered talk at CICON, which is being held in New York, NY from
September 28 – October 1, 2022.
Details of the presentation are as follows:
Title: Objective clinical response by KRAS
mutation-specific TCR-T cell therapy in previously treated advanced
Non-small cell lung cancerPresenter: Marcelo V.
Negrao, MD, Department of Thoracic-Head & Neck Medical
Oncology, Division of Cancer Medicine at MD AndersonDate
and Time: Friday, September 30, 2022, 8:30am
ETSession Title: Session 6: Cellular Therapies:
Engineering T cells
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 a clinical and strategic
collaboration with 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 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 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 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
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