On January 27, 2025 Triumvira Immunologics, a clinical-stage company developing novel, targeted autologous and allogeneic T cell therapeutics that co-opt the natural biology of T cells to treat patients with solid tumors, reported an abstract at the 2025 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Gastrointestinal Cancers Symposium, which was held in San Francisco, California, from January 23-25, 2025 (Press release, Triumvira Immunologics, JAN 27, 2025, View Source [SID1234649895]). The company showcased updated clinical data from its ongoing Phase I/II TACTIC-3 study investigating the safety and efficacy of autologous TAC-T cells in subjects with Claudin 18.2+ advanced solid tumors (TACTIC-3 /NCT05862324).
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The poster presentation, titled "A Phase 1/2 Study Evaluating the Safety and Efficacy of Autologous TAC-T Cells in Subjects with Claudin 18.2+ Advanced Solid Tumors", provided an in-depth look at interim results from the Phase I study. Key highlights included:
Patient Demographics and Characteristics: The study included subjects with multiple types of Claudin 18.2 positive advanced solid tumors, such as pancreatic, gastric, and esophageal cancers. .
Safety Data: TAC01-CLDN18.2 demonstrated a favorable safety and tolerability profile. Two grade 3 events, gastritis and gastric hemorrhage, were observed in the same dose-level 3 (DL3) patient, and resolved within 4 days with supportive care. One Grade 1 immune-effector cell-associated neurotoxicity (ICAN) event resolved within 24 hours without intervention. Low-grade cytokine release syndrome (CRS) events were resolved with standard treatment.
Preliminary Efficacy: Early clinical activity was observed, with a confirmed, ongoing partial response in a dose-level 1 (DL1) subject with stage IV pancreatic cancer, and an unconfirmed partial response in a heavily pretreated subject with esophageal adenocarcinoma (DL3). The disease control rate (DCR) was 70%, with an objective response rate (ORR) of 20% in a patient population that was not restricted based Claudin 18.2 expression levels, tumor burden, or location of metastatic disease.
The TAC technology platform, exemplified by TAC01-CLDN18.2, reprograms T cells to co-opt the natural T cell receptor (TCR) signaling complex, providing precise tumor targeting and reduced systemic toxicity compared to conventional engineered T cell therapies.