On October 31, 2022 Turnstone Biologics Corp, a clinical-stage biotechnology company developing next-generation immunotherapies to treat and cure solid tumors, reported that the U.S. Food and Drug Administration (FDA) has cleared its Investigational New Drug (IND) for Turnstone’s lead selected tumor-infiltrating lymphocyte (TIL) therapy program, TIDAL-01 (Press release, Turnstone Biologics, OCT 31, 2022, View Source [SID1234622644]). Turnstone is expected to commence a multi-site Phase 1 clinical trial later this year that will evaluate its safety and anti-tumor activity. This trial represents the second Phase 1 clinical study of TIDAL-01, which separately is being evaluated in collaboration with Moffitt Cancer Center.
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"Clearance of our IND is a critical milestone for Turnstone in the advancement of our novel TIL therapy pipeline," said Sammy Farah, Ph.D., M.B.A., President and Chief Executive Officer, Turnstone Biologics. "TIDAL-01 is a potentially transformative approach to improving the potency of TILs and bringing the clinical benefit of Selected TILs to patients with solid tumor cancers where the unmet medical need is high. We are eager to commence the clinical study for TIDAL-01 and to progress this candidate through the clinic."
Selected TILs represent the foundational therapeutic modality driving Turnstone’s cancer immunotherapy pipeline and leverage decades of work anchored in academic research that has demonstrated the promise of this approach. By identifying, selecting, and expanding the most potent subsets of patient specific tumor-reactive T-cells, Turnstone aims to improve and broaden the clinical efficacy of TILs, and to overcome the limitations of current TIL-based therapies to achieve positive outcomes in harder to treat, lower mutational burden cancers. The STARLING trial, Turnstone’s multi-site Phase 1 clinical trial of TIDAL-01, will enroll patients with advanced solid tumors including breast cancer and colorectal cancer. Additionally, TIDAL-01 is being evaluated in a Moffitt Cancer Center-sponsored Phase 1 clinical study in additional solid tumors, including cutaneous and non-cutaneous melanoma.
"To achieve success against solid tumors, we are applying a differentiated approach with TILs to overcome what we believe to be the greatest barrier to more effective cell therapies: the low amount of T-cells that recognize and attack the tumor," said Stewart Abbot, Ph.D., Chief Scientific Officer, Turnstone Biologics. "In identifying, selecting and expanding these tumor-reactive T-cells, we aim to drive more potent solid tumor killing and improved clinical outcomes in multiple different cancer indications."