Alaunos Therapeutics to Present Early Data from TCR-T Library Phase 1/2 Trial at 2023 American Society of Clinical Oncology Annual Meeting - Seite 2

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.

Maria Pia Morelli, M.D., Ph.D., Assistant Professor, Department of Gastrointestinal Medical Oncology at The University of Texas MD Anderson Cancer Center and presenter of the poster, added, “TCR-T cell therapy has shown early promise as a potential cancer treatment. There remains a significant unmet medical need for new, patient-specific therapies for people living with difficult-to-treat solid tumor cancers. These early data are encouraging as they showed an objective clinical response and persistence alongside a favorable safety and tolerability profile in patients who have not responded to prior lines of therapy. These data support continued evaluation of driver-mutation reactive TCR-T cells for the treatment of solid tumors, and we look forward to continuing enrollment in the trial.”

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. The full abstract is now available on the ASCO conference website.

Alaunos expects to provide an interim data update on multiple new patients in the third quarter of 2023 and anticipates establishing a recommended Phase 2 dose by year-end 2023.

About the TCR-T Library Phase 1/2 Trial
The TCR-T Library Phase 1/2 trial is an open-label, dose-escalation trial being conducted at MD Anderson. The trial is actively enrolling patients with NSCLC, colorectal, endometrial, pancreatic, ovarian and bile duct cancers that have a matching human leukocyte antigen (HLA) whose tumors contain at least one of the targeted driver mutations in KRAS, TP53 and EGFR. Additional information about the trial is available at www.clinicaltrials.gov using the identifier NCT05194735.