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Turnstone, Moffitt Cancer Center Get FDA Permission to Study TIL Therapy in Melanoma Patients

NEW YORK – Turnstone Biologics and Moffitt Cancer Center on Wednesday announced they've received the US Food and Drug Administration's permission to begin human trials of a tumor-infiltrating lymphocyte treatment, dubbed TIDAL-01, for melanoma.

New York-based Turnstone acquired TIDAL-01 when it purchased Myst Therapeutics and its pipeline of TIL therapies last year. In November 2021, Turnstone started working with Tampa, Florida-based Moffitt on the preclinical development of these therapies and planning an investigational new drug application submission for TIDAL-01.

The partners on Wednesday said they are extending their collaboration, under which Turnstone will have access to Moffitt's cell therapy research infrastructure and good manufacturing practices-compliant facility to manufacture the TIL products. Turnstone will also be able to tap into Moffitt's patient screening and data sharing systems, molecular datasets, and biobank for research purposes.

Turnstone, for its part, will fund the research on the TIL therapies and provide other resources and expertise. The partners did not disclose the financial terms of their collaboration.

Following IND clearance from the FDA, Turnstone is expecting to begin enrolling patients with cutaneous and non-cutaneous melanoma later this year into the Phase I trial for TIDAL-01. The New York-based firm considers TIDAL-01 a "next-generation" TIL therapy, since it involves identifying and selecting the most potent autologous tumor-reactive T cells for targeting patients' tumors and expanding those ex vivo before reinfusing them into patients. Earlier generation TIL therapies in development do not necessarily involve selecting the most potent T cells, which Turnstone believes may make its products more effective for cancer patients with lower mutational burdens.

This spring, Turnstone also announced a selected TIL therapy-focused partnership with the University of Montreal.