On July 6, 2022 Turnstone Biologics Corp., a clinical-stage biotechnology company developing next-generation immunotherapies to treat and cure solid tumors, and Moffitt Cancer Center ("Moffitt"), a world leader in advancing cellular immunotherapies for the treatment of cancer, reported the formation of a broad strategic alliance, deepening their existing multi-year research collaboration (Press release, Turnstone Biologics, JUL 6, 2022, View Source [SID1234616515]). As part of this expanded partnership, Turnstone will have priority access to Moffitt’s scientific research, manufacturing, and clinical capabilities for the development of novel tumor infiltrating lymphocyte ("TIL") therapies. The parties also announced U.S. Food and Drug Administration ("FDA") clearance of an Investigational New Drug ("IND") application for a Moffitt-sponsored Phase 1 clinical study of TIDAL-01, Turnstone’s lead TIL therapy candidate, in cutaneous and non-cutaneous melanoma. The trial is expected to commence later this year.
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"Our landmark strategic alliance with Turnstone underscores Moffitt’s commitment to bold research initiatives and groundbreaking clinical studies for the benefit of cancer patients who have limited or no effective treatment options," said Patrick Hwu, M.D., President and CEO, Moffitt Cancer Center. "Cell therapy is a key area of focus at Moffitt, and we are impressed by Turnstone’s novel approach to TIL therapy. Our combined team has made strong progress as part of our ongoing partnership, particularly with the IND clearance of TIDAL-01. We look forward to initiating the clinical study in melanoma and continuing to grow this valuable relationship with Turnstone."
Selected TILs represent the foundational therapeutic modality driving Turnstone’s cancer immunotherapy pipeline and leverage decades of work anchored in academia that have 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 overcome the limitations of current treatments to achieve positive outcomes in harder to treat, lower mutational burden, cancers. TIDAL-01 builds on the historical clinical success of Selected TIL treatment protocols and is the initial focus of the Turnstone-Moffitt collaboration as the parties advance the program into a Phase 1 clinical study.
Under the terms of the agreement, Moffitt will grant Turnstone prioritized clinical trial activation, enhanced patient screening and data sharing, full access to Moffitt’s cellular therapies research and development infrastructure and expanded molecular data sets and biospecimens for research. Moffitt will also provide extended governance support and allocated GMP manufacturing capacity for Turnstone product candidates. Turnstone will contribute resources and expertise to the partnership and fund research and development activities at Moffitt. Additional financial terms were not disclosed.
"This industry-leading partnership with Moffitt is a direct result of our unwavering efforts to develop promising new cancer medicines in the most innovative and impactful ways possible," said Sammy Farah, Ph.D., M.B.A., President and CEO, Turnstone Biologics. "We believe Moffitt’s translational insights and clinical execution capabilities coupled with our next-generation Selected TIL technology will accelerate the development of our differentiated TIL therapies and increases our opportunity to create curative outcomes for patients with solid tumors."