Alaunos Therapeutics Highlights Data from TCR-T Library Phase 1/2 Trial at the CRI-ENCI-AACR Sixth International Cancer Immunotherapy Conference
21 September 2022 - 10:30PM
Alaunos Therapeutics, Inc. (“Alaunos” or the “Company”) (Nasdaq:
TCRT), a clinical-stage oncology-focused cell therapy company,
today announced early clinical data from the first patient in its
ongoing TCR-T Library Phase 1/2 trial. The data will be presented
during a proffered talk at the CRI-ENCI-AACR Sixth International
Cancer Immunotherapy Conference (CICON) being held in New York, NY
from September 28 through October 1, 2022.
“The encouraging data from the first patient in
our trial highlight the potential of our non-viral TCR-T cell
therapies to treat solid tumors even at the lowest doses in the
study design,” said Kevin S. Boyle, Sr., Chief Executive Officer of
Alaunos. “Patients with solid tumors represents a large unmet
medical need, and the results from the first patient are quite
promising that our TCR-T cell therapy may offer them hope. We look
forward to treating additional patients and are grateful for the
continued support from our investigators, patients and our
dedicated team.”
Marcelo V. Negrao, MD, Department of
Thoracic/Head & Neck Med Onc, Division of Cancer Medicine at
The University of Texas MD Anderson Cancer Center added, “These
clinical data, where a greater than 51% tumor regression in a
patient with NSCLC was observed, are encouraging. We believe this
data adds to the growing body of evidence indicating that targeting
shared tumor-specific hotspot mutations using TCRs has the
potential to transform the way we treat solid tumor cancers. In
addition, we believe that the manageable safety and tolerability
profile is reassuring, and we look forward to continuing enrollment
in the study.”
The TCR-T Library Phase 1/2 trial is an open
label, dose escalation study being conducted at MD Anderson. 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.
Key highlights to be presented:
- First patient dosed was diagnosed
with non-small cell lung cancer and had previously progressed on
three prior lines of treatment. The patient was germline for
HLA-A*11:01 with a KRAS G12D mutation, matching one of the ten TCRs
within Alaunos’ TCR library.
- The patient received standard
cy/flu lymphodepletion1 prior to an infusion of 9x109 TCR-T cells,
which were produced using Sleepy Beauty at the Company’s in-house
cGMP manufacturing facility.
- The patient was confirmed to have
achieved a partial response with a regression of 46.3% in target
lesions at six weeks, which subsequently deepened to 51.2% at week
12. T-cell persistence was ongoing as of week 12.
- The TCR-T cell therapy was
well-tolerated and a manageable safety profile was observed in the
first patient.
- The patient experienced grade 2
cytokine release syndrome (CRS) which resolved with nasal cannula
oxygen supplementation and did not require anti-IL-6 treatment.
Grade 4 thrombocytopenia and grade 3 anemia occurred and were both
attributed to the lymphodepletion regimen.
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, 9:00-9:15am
ETSession Title: Session 6: Cellular Therapies:
Engineering T cells
The full abstract may be accessed by visiting
www.cancerimmunotherapyconference.org.
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 timeline for
enrolling and dosing patients 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 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
1 Cyclophosphamide (60 mg/kg for 2 days) and
Fludarabine (25 mg/m2 for 5 days)
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