Turnstone Biologics Inc

Turnstone Biologics has halted the development of TIDAL-01, their selected tumor infiltrating lymphocyte (TIL) therapy, citing capital-intensive manufacturing requirements and current market conditions.

Turnstone Biologics announces immediate discontinuation of all clinical studies for its Selected TIL therapy TIDAL-01, citing capital-intensive manufacturing requirements and challenging financial market conditions.

• Turnstone Biologics is prioritizing its clinical program, TIDAL-01, a Selected TIL therapy, and streamlining operations to extend its cash runway into the second quarter of 2026. • The company is reducing its workforce by approximately 60% as part of a strategic realignment to focus on clinical development and manufacturing efforts. • Initial Phase 1 data from the STARLING trial supports the biological hypothesis for TIL selection, showcasing a complete response in a heavily pre-treated MSS-CRC patient. • Leadership transitions include Ines Verdon assuming leadership of clinical activities and Michael Fitch overseeing manufacturing, with other changes in finance and operations.

• The FDA approved Roche's Itovebi, inavolisib, for HR-positive, HER2-negative breast cancer with PIK3CA mutation, to be used with Pfizer’s Ibrance and endocrine therapy. • Turnstone Biologics is restructuring, laying off 60% of its workforce to focus on a Phase 1 cancer cell therapy program for solid tumors, with updates expected next year. • Pfizer's Talzenna combined with Xtandi showed prolonged survival in advanced prostate cancer patients, regardless of genetic alterations, seeking expanded use. • Gritstone bio filed for bankruptcy after disappointing vaccine study results; Denali Therapeutics' multiple sclerosis drug, oditrasertib, failed in Phase 2 trial.