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Alaunos, NCI Expand Partnership to Explore Personalized Autologous T-Cell Therapy

NEW YORK – Alaunos Therapeutics has expanded an agreement with the National Cancer Institute to study its T-cell receptor (TCR) therapy in patients with solid tumors, the company said on Monday.

In 2019, Houston-based Alaunos struck up an exclusive patent license agreement with the NCI to study TCR therapies in advanced cancer patients. Under an expanded cooperative research and development agreement, Alaunos and the NCI have now agreed to collaborate until January 2025, and to generate proof-of-concept data on autologous T cells created using the company's non-viral Sleeping Beauty platform. The research will be led by Steven Rosenberg, chief of the surgery branch at NCI's Center for Cancer Research.

Sleeping Beauty, a transposon/transposase gene transfer system, engineers T cells expressing TCRs that target hotspot neoantigens, such as KRAS, TP53, and EGFR mutations prevalent in lung, gastrointestinal, and gynecological cancers. According to Alaunos, TCR T-cell therapies can be manufactured at a much lower cost than technologies based on viral gene transfer or gene editing.

In May, Alaunos (formerly Ziopharm Oncology) began dosing patients in a Phase I/II trial of its TCR-T cell therapy for solid tumors harboring KRAS, TP53, or EGFR mutations. The trial will involve around 180 patients with advanced, previously treated non-small cell lung, colorectal, endometrial, pancreatic, ovarian, and bile duct cancers.

"We believe that our non-viral means of adding the TCR to T cells is well suited for a personalized approach, with potential to further increase the addressable population for TCR-T therapies," Drew Deniger, Alaunos VP of R&D, said in a statement.