Press Release
Ziopharm Oncology Highlights Operational Progress & Rebrands to Alaunos Therapeutics
- Phase 1/2
TCR-T Library trial targeting KRAS, TP53 and EGFR mutations across six solid tumor indications is open for enrollment; continue to expect to dose the first patient in 1H 2022
- Phase 1/2 IND amended to include four additional TCRs, bringing the total number of evaluable TCRs to 10, further expanding number of eligible patients
- In-house cGMP manufacturing facility is operational to support internal clinical development programs
- Company changes name to Alaunos Therapeutics reflecting renewed focus
"We are very pleased to announce that our Phase 1/2 TCR-T library trial is now open for enrollment at
“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
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 inHouston . 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 onThe Nasdaq Stock Market under the new ticker symbol “TCRT”, to be effective at market open onJanuary 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 itsBoston office. Alaunos will be headquartered inHouston .
About
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
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
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Alex.lobo@sternir.com
Source: ZIOPHARM Oncology Inc