On September 21, 2022 Alaunos Therapeutics, Inc. ("Alaunos" or the "Company") (Nasdaq: TCRT), a clinical-stage oncology-focused cell therapy company, reported early clinical data from the first patient in its ongoing TCR-T Library Phase 1/2 trial (Press release, Alaunos Therapeutics, SEP 21, 2022, View Source [SID1234621306]). The data will be presented during a proffered talk at the CRI-ENCI-AACR Sixth International Cancer Immunotherapy Conference (CIMT) (Free CIMT Whitepaper) (CICON) being held in New York, NY from September 28 through October 1, 2022.

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"The encouraging data from the first patient in our trial highlight the potential of our non-viral TCR-T cell therapies to treat solid tumors even at the lowest doses in the study design," said Kevin S. Boyle, Sr., Chief Executive Officer of Alaunos. "Patients with solid tumors represents a large unmet medical need, and the results from the first patient are quite promising that our TCR-T cell therapy may offer them hope. We look forward to treating additional patients and are grateful for the continued support from our investigators, patients and our dedicated team."

Marcelo V. Negrao, MD, Department of Thoracic/Head & Neck Med Onc, Division of Cancer Medicine at The University of Texas MD Anderson Cancer Center added, "These clinical data, where a greater than 51% tumor regression in a patient with NSCLC was observed, are encouraging. We believe this data adds to the growing body of evidence indicating that targeting shared tumor-specific hotspot mutations using TCRs has the potential to transform the way we treat solid tumor cancers. In addition, we believe that the manageable safety and tolerability profile is reassuring, and we look forward to continuing enrollment in the study."

The TCR-T Library Phase 1/2 trial is an open label, dose escalation study being conducted at MD Anderson. 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.

Key highlights to be presented:

First patient dosed was diagnosed with non-small cell lung cancer and had previously progressed on three prior lines of treatment. The patient was germline for HLA-A*11:01 with a KRAS G12D mutation, matching one of the ten TCRs within Alaunos’ TCR library.
The patient received standard cy/flu lymphodepletion1 prior to an infusion of 9×109 TCR-T cells, which were produced using Sleepy Beauty at the Company’s in-house cGMP manufacturing facility.
The patient was confirmed to have achieved a partial response with a regression of 46.3% in target lesions at six weeks, which subsequently deepened to 51.2% at week 12. T-cell persistence was ongoing as of week 12.
The TCR-T cell therapy was well-tolerated and a manageable safety profile was observed in the first patient.
The patient experienced grade 2 cytokine release syndrome (CRS) which resolved with nasal cannula oxygen supplementation and did not require anti-IL-6 treatment. Grade 4 thrombocytopenia and grade 3 anemia occurred and were both attributed to the lymphodepletion regimen.
Details of the presentation are as follows:

Title: Objective clinical response by KRAS mutation-specific TCR-T cell therapy in previously treated advanced non-small cell lung cancer
Presenter: Marcelo V. Negrao, MD, Department of Thoracic-Head & Neck Medical Oncology, Division of Cancer Medicine at MD Anderson
Date and Time: Friday, September 30, 2022, 9:00-9:15am ET
Session Title: Session 6: Cellular Therapies: Engineering T cells