On September 6, 2022 Alaunos Therapeutics, Inc. ("Alaunos" or the "Company") (Nasdaq: TCRT), a clinical-stage oncology-focused cell therapy company, reported early clinical findings from its ongoing TCR-T Library Phase 1/2 trial (Press release, Alaunos Therapeutics, SEP 6, 2022, View Source [SID1234619073]).

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"We are excited to announce early findings from our TCR-T Library trial. This is the first time that an objective clinical response has been observed in a solid tumor cancer in connection with non-viral TCR-T cell therapy," said Kevin S. Boyle, Sr., Chief Executive Officer of Alaunos. "We believe this reinforces our approach targeting shared tumor-specific hotspot mutations using our non-viral Sleeping Beauty technology. We look forward to presenting additional details at the CICON conference on September 30."

The TCR-T Library Phase 1/2 trial is an open label, dose escalation study being conducted at The University of Texas MD Anderson Cancer Center. 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 library. The first patient dosed was diagnosed with non-small cell lung cancer with a KRAS G12D mutation, matching one of the ten TCRs within the Company’s TCR library. The patient received TCR-T cells, which were produced using Sleeping Beauty at the Company’s in house cGMP manufacturing facility. The patient had a confirmed objective partial response. The Company has dosed a second patient in the study, diagnosed with colon cancer, who has been treated at the second dose level and has cleared the 28-day safety window.

"While cell therapies have demonstrated success in hematological cancers, there remains a significant unmet medical need for effective and cost-efficient cell therapies for patients with solid tumors, which account for nearly 90% of all cancer diagnoses. These early clinical findings show the potential for the first time that we may be able to use a non-viral TCR-T cell therapy to achieve measurable regression in solid tumors," added Marcelo V. Negrao, MD, Department of Thoracic-Head & Neck Medical Oncology, Division of Cancer Medicine at MD Anderson. "We are encouraged by these findings, and we look forward to continuing enrollment in the study."

Data is scheduled to be presented during a proffered talk at CICON, which is being held in New York, NY from September 28 – October 1, 2022.