Alaunos Therapeutics Doses First Patient in TCR-T Library Phase 1/2 trial for the Treatment of Patients with Solid Tumors

  • First-in-human non-viral TCR-T cell therapy targeting shared hotspot mutations in solid cancers
  • First clinical product manufactured and administered to a patient using the Company’s in house cGMP manufacturing facility
  • Expect to report initial data in 2H22

HOUSTON, TX, USA I May 02, 2022 I Alaunos Therapeutics, Inc. (“Alaunos” or the “Company”) (Nasdaq: TCRT), a clinical-stage oncology-focused cell therapy company today announced that the first patient has been dosed in its TCR-T Library Phase 1/2 trial targeting KRAS, TP53, and EGFR mutations across six solid tumor indications using the Company’s Sleeping Beauty transposon/transposase technology.

“Dosing the first patient in our TCR-T Library Phase 1/2 trial represents a significant accomplishment for Alaunos. Our team has worked diligently to achieve this milestone and bring our TCR-T cell therapy to cancer patients,” commented Kevin S. Boyle, Sr., Chief Executive Officer of Alaunos. “We believe that our adaptive trial design has the potential to allow us to rapidly and cost effectively identify the recommended phase 2 dose and quickly advance studies in the most promising indications. We look forward to an initial data readout in the second half of this year.”

The Phase 1/2 study is being conducted at The University of Texas MD Anderson Cancer Center and is an open label, dose escalation study, with patients being treated in one of three dose cohorts: 5x109, 4x1010, 1x1011 TCR-T cells. 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. The main study objectives are to define the maximum tolerated dose, recommended phase 2 dose and safety profile.

Carl June, M.D., Chairman of the Alaunos Scientific Advisory Board added, “This is a significant accomplishment as the first-in-human dosing of a patient with Sleeping Beauty TCR-T cells. This approach targeting shared driver mutations that are at the core of cancer provides hope of meaningful clinical responses.”

For more information regarding the trial design please see www.clinicaltrials.gov (identifier: NCT05194735).

About Alaunos Therapeutics
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 technology and its TCR library targeting shared tumor-specific hotspot 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.

SOURCE: AlaunosTherapeutics

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