Ziopharm Oncology Highlights Operational Progress & Rebrands to Alaunos Therapeutics
January 26 2022 - 7:00AM
Ziopharm Oncology, Inc. (“Ziopharm” or the “Company”) (Nasdaq:
ZIOP), a clinical-stage oncology-focused cell therapy company,
today highlighted recent operational and corporate updates. The
Company also announced that it has changed its name to Alaunos
Therapeutics, Inc. (“Alaunos” or the “Company”).
"We are very pleased to announce that our Phase
1/2 TCR-T library trial is now open for enrollment at MD Anderson
Cancer Center. This first of its kind study, enabled by our
versatile non-viral Sleeping Beauty technology, will allow us to
efficiently target six solid tumor indications within this single
clinical trial. In addition, our R&D efforts continue to bear
fruit and we amended our IND to include four additional TCRs to the
study. This further increases the number of eligible patients who
could benefit from our therapies, and we look forward to dosing the
first patient in this study within the first half of this year.
Lastly, to support our clinical development, we have successfully
opened our cGMP manufacturing facility and we are now able to
manufacture our autologous cell therapy products in-house,”
commented Kevin S. Boyle, Sr., Chief Executive Officer.
“Over the course of 2022, the team will continue
to work diligently with an execution mindset to deliver results. In
addition to translating groundbreaking science into meaningful
clinical progress we will work to advance our membrane bound IL-15
program with IND enabling studies. Our name change to Alaunos
Therapeutics reflects the completion of our transition to a TCR-T
focused company and embodies our mission of developing novel
therapies for cancer patients,” concluded Mr.
Boyle. Operational
Updates
- Phase 1/2 TCR-T Library
Program Open for Enrollment: Alaunos’ phase 1/2 clinical
trial is evaluating library TCR-T shared hotspot neoantigens using
the Company’s Sleeping Beauty transposon/transposase technology.
The Company added four additional T-cell receptors (TCRs) to its
library, further increasing the number of eligible patients for the
clinical trial. The study being conducted at MD Anderson Cancer
Center is an open label, dose escalation study that will enroll
patients who have a matched HLA and hotspot mutation that is a
targeted by one of the 10 TCRs from the Alaunos library. The trial
will evaluate 10 unique TCRs targeting KRAS, TP53 and EGFR
mutations in patients across a broad range of solid tumors that
include non-small cell lung, colorectal, endometrial, pancreatic,
ovarian, and bile duct cancers, all in a single trial. The Phase 1
primary endpoint is maximum tolerated dose or recommended phase 2
dose. The Company expects to dose the first patient in the first
half of 2022 and to provide an interim data update later this year.
Additional information about the study is available at
www.clinicaltrials.gov using the identifier: NCT05194735.
- In-House cGMP Manufacturing
Facility Operational: Alaunos completed the qualification
of its state-of-the-art good manufacturing practice (cGMP) TCR
manufacturing facility near the Texas Medical Center in Houston.
The facility is staffed by Alaunos personnel and is fully
operational for the manufacture and release of clinical
product.
- hunTR™
(human
neoantigen
T-cell
Receptor) Platform for TCR
Discovery: Alaunos’ TCR hunting process, hunTR™, enables
the rapid identification of new and proprietary TCRs from CD4+ and
CD8+ T cells to further expand the Company’s growing TCR-T library.
The platform can evaluate thousands of single T cells
simultaneously using state-of-the-art bioinformatics and next
generation sequencing to identify TCRs specific for neoantigens
that arise from hotspot mutations. The proprietary high-throughput
TCR screening process permits rapid functional validation of TCRs.
Newly discovered neoantigen-specific TCRs will then undergo further
development required to potentially qualify the TCR for inclusion
in the Company’s TCR library and clinical evaluation.
Corporate Updates
- Name Change to Alaunos
Therapeutics, Inc.: The name Alaunos originates from the
Celtic mythological god of healing, reflecting the Company’s
commitment to developing therapies for cancer patients. The Company
will trade on The Nasdaq Stock Market under the new ticker symbol
“TCRT”, to be effective at market open on January 27, 2022. In
conjunction with the corporate name change, the Company has
launched a new website, www.alaunos.com, which contains
information about the Company and its innovative TCR-T
platform.
- Closure
of Boston, MA Location: To streamline operations, the
Company has closed its Boston office. Alaunos will be headquartered
in Houston.
About Alaunos Therapeutics,
Inc.Alaunos 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 platform and its unique cancer mutation hotspot TCR
library, targeting common tumor-related 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 ability to raise capital, and the timing of the
Company's research and development programs, including the
anticipated dates for enrolling and dosing patients in 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-Q and
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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