Turnstone Biologics Corp. Reports Positive Initial Data from Phase 1 Trial of TIDAL-01 in Metastatic Colorectal Cancer

• Overall response rate (“ORR”) of 25% and 50% disease control rate (“DCR”) observed in first four evaluable patients treated with TIDAL-01 with advanced CRC
• Complete response achieved in heavily pre-treated late line patient with progression free survival extending beyond one year
• Favorable tolerability profile and demonstrated manufacturing success
• Product characterization and translational data support biological hypothesis for Selected TILs

Excerpt from the Press Release:

SAN DIEGO, Aug. 14, 2024 (GLOBE NEWSWIRE) — Turnstone Biologics Corp. (“Turnstone” or the “Company”) (Nasdaq: TSBX), a clinical-stage biotechnology company developing a differentiated approach to treat and cure patients with solid tumors by pioneering selected tumor-infiltrating lymphocyte (Selected TIL) therapy, today reported positive initial data from its Phase 1 STARLING trial of TIDAL-01 in metastatic microsatellite stable colorectal cancer (“MSS mCRC”).

Turnstone’s Phase 1 STARLING trial is an ongoing muti-site, first-in-human, non-randomized, open label, single-dose study, and is evaluating the safety, tolerability, and clinical activity of TIDAL-01. The trial is currently enrolling patients with colorectal cancer, head and neck squamous cell carcinoma, and uveal melanoma. As of the cutoff date of July 15, 2024, key takeaways from the initial data include the following:

• Clinical Responses: Among the four evaluable MSS mCRC patients included in the study, Turnstone observed a 25% overall response rate (“ORR”) and 50% disease control rate (“DCR”). One patient demonstrated a deep and durable ongoing complete response (CR).
• Durability of Response: 50% of patients showed sustained clinical benefit, with notable progression free survival of over one year in the patient with ongoing complete response and 6 months for a patient with stable disease.
• Translational Profile: The TIDAL-01 process demonstrated the ability to generate high titer, polyclonal and multi-epitope tumor neoantigen-reactive T cells that expanded in the patient, persisted in the blood and correlated with an increase in CD8 T cell tumor infiltration.

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