- TCR-T cell therapy shows first-in-human response for non-viral TCR-T therapy; effectively targets high frequency TP53 and KRAS driver mutations across multiple solid tumor indications
- Treatment was well tolerated with a manageable safety profile and persistence of TCR-T cells in peripheral blood observed in all three treated patients at last follow-up
- Proof-of-concept demonstrated for non-viral Sleeping Beauty cell engineering platform in effective manufacturing of TCR-T cell therapies with all products achieving >90% TCR positivity
- Data to be presented on
Saturday, June 3 , at8:00 a.m. CT
“Demonstrating our first objective clinical response in solid tumors using non-viral TCR-T cell therapy establishes proof-of-concept of our Sleeping Beauty cell engineering platform’s potential to generate safe, persistent and effective TCR-T therapies,” said
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
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.
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