Alaunos Therapeutics Highlights Strategic Priorities and Anticipated Portfolio Milestones for 2023
10 January 2023 - 12:30AM
Alaunos Therapeutics, Inc. (“Alaunos” or the “Company”) (Nasdaq:
TCRT), a clinical-stage oncology-focused cell therapy company today
highlights its expected milestones and strategic priorities for
2023.
“Achieving the first-in-human objective clinical
response in a patient with a solid tumor using a non-viral TCR-T
cell therapy made for an exciting 2022. We believe we are well
positioned to increase the pace of enrollment in 2023 and with the
addition of two new TCRs to our library we have doubled the
potential addressable market of our therapy,” commented Kevin S.
Boyle, Sr., Chief Executive Officer of Alaunos. “In December we
treated our third patient, a pancreatic patient, with a KRAS-G12V
mutation. The year ahead will focus on increasing patient
enrollment with an aim towards advancing the program to Phase 2
readiness. We are excited about our progress to date and as leaders
in the TCR-T cell therapy space we look forward to bringing the
promise of our therapies to even more patients in need.”
Anticipated 2023 Milestones and
Strategic Priorities
Expand TCR library using hunTR® TCR
discovery platform to increases addressable market: In the
fourth quarter of 2022, the Company submitted an IND amendment to
the U.S. Food and Drug Administration (FDA) adding two new TCRs to
its clinical trial targeting frequent mutations and HLAs, with the
potential to double the addressable market of its TCR-T
program. The addition of these new TCRs highlights our strategy to
add both more HLAs to existing mutations (KRAS-G12V and
HLA-DRB1*07:01) and new mutations within our targeted gene families
(TP53-R273C and HLA-DPB1*04:02). In 2023, the Company expects to
further expand its library with exclusively owned TCRs targeting
recurrent hotspot mutations in KRAS, TP53 and EGFR.
Advance TCR-T library program to Phase 2
readiness: The Company continues to actively enroll
patients in its TCR-T Library Phase 1/2 trial targeting KRAS, TP53,
and EGFR hotspot mutations across six solid tumor indications. In
September 2022, the Company announced the first objective clinical
response from a TCR-T cell therapy using non-viral Sleeping Beauty
targeting solid tumors. The Company successfully dosed its third
patient in the trial in December 2022 and expects to enroll
multiple patients in the first half of 2023. Alaunos anticipates
providing an interim data update by mid-2023 as it works towards
advancing the program into Phase 2.
Optimize manufacturing process towards
commercial scalability: The Company continues to execute
on its multi-pronged strategy to expand manufacturing capacity and
efficiency. The Company doubled its manufacturing capacity in 2022
allowing for production of two products simultaneously. The Company
also filed an IND amendment to move from fresh to cryopreserved
product and expects to begin implementing this change in the first
half of 2023. The use of cryopreserved cell products will reduce
manufacturing process time from 30 days to 26 days, a 13% decrease,
while increasing flexibility for patient scheduling and treatment.
The Company has ongoing initiatives to optimize the process and
further reduce the manufacturing time.
Explore next generation TCR-T cell
therapy approaches to deepen clinical responses: The
Company is advancing its mbIL-15 TCR-T cell therapy program towards
an IND filing anticipated in the second half of 2023. The Company
believes mbIL-15 has the potential to increase the survival of
TCR-T cells in the harsh tumor microenvironment and deepen clinical
responses. In addition, Alaunos continues to conduct translational
assessments of treated patients to guide next generation TCR-T
therapy approaches including potential combination and multiplexed
TCR-T cell therapies.
Cash Position and Financial
Guidance
Alaunos ended the fourth quarter of 2022 with
unaudited cash and cash equivalents of approximately $39.1 million
and restricted cash of approximately $13.9 million. Based on
current operating plans, the Company expects its operating cash
flow for 2023 to be between approximately $35 million and $40
million. The Company expects to have sufficient cash resources to
fund research and development programs and operations into Q4
2023.
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.
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 cash runway
and forecast operating cash flow, 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 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
Alaunos Therapeutics (NASDAQ:TCRT)
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