Alaunos Therapeutics, Inc. announced that the Company will present early translational data from the first three patients treated in its ongoing TCR-T Library Phase 1/2 trial at the 2023 American Society of Clinical Oncology (ASCO) Annual Meeting taking place June 2-6, 2023, at the McCormick Place Convention Center in Chicago. The poster will highlight early clinical and translational data on the first three patients with refractory solid tumors expressing KRAS or TP53 mutations who received Sleeping Beauty TCR-T cells at one of two dose levels, DL1 (0.9 x 1010 TCR-T cells) and DL2 (6.4 x 1010 TCR-T cells and 5.8 x 1010 TCR-T cells). Manufactured TCR-T cells exhibited greater than 90% TCR positivity, viability and purity, underscoring the ability of the Company's non-viral, universal manufacturing process to create TCR-T cells in multiple indications with different TCRs.

Overall, the TCR-T cell therapy was observed to be well-tolerated and presented a manageable safety profile, with no dose-limiting toxicities or immune effector cell-associated neurotoxicity syndrome observed and only one instance of grade three cytokine release syndrome, which was resolved with administration of tocilizumab. Anti-tumor activity was seen in two patients, as previously reported, including one patient with non-small cell lung cancer (NSCLC) who achieved partial response with six-month progression-free survival, and one colorectal cancer patient who achieved a best overall response of stable disease at six weeks with three-month progression-free survival. The third patient, a 60-year-old gentleman with advanced, chemotherapy-refractory stage IV pancreatic cancer, experienced progressive disease.

TCR persistence and tumor infiltration were observed in patients at last follow-up and out to seven months post-infusion in the NSCLC patient. The data will be presented during a poster session at the 2023 ASCO Annual Meeting on Saturday, June 3, 2023, between 8:00 – 11:00 a.m. CT.