Triumvira Immunologics Announces Updated Data from Ongoing TACTIC 2 Trial of TAC01-HER2 in Patients with HER2 Positive Solid Tumors

Clinical activity observed in third dosing cohort and sustained clinical benefit in second cohort

AUSTIN, TX & SOUTH SAN FRANCISCO, CA, USA & HAMILTON, Canada I November 11, 2022 I Triumvira Immunologics (“Triumvira”), 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 cancer, today announced updated positive clinical data from its ongoing TACTIC‑2 Phase 1/2 trial of TAC01-HER2 in patients with human epidermal growth factor receptor 2 (HER2) positive solid tumors will be shared in a poster at the Society for Immunotherapy of Cancer’s (SITC) 37th Annual Meeting from November 8-12, 2022.

These interim data demonstrate that TAC01-HER2 is well-tolerated and clinical activity was observed in the two higher dosing cohorts with a 67% disease control rate in cohort 3 (n=3; 1-3 x 106 cells/kg), with signs of continued clinical activity observed in two patients, one with stage IV gastroesophageal junction cancer and one with stage IV breast cancer. Both patients in cohort 3 show stable disease at their first and second scans. Building on initial data from cohort 2 presented at ESMO 2022, a patient with stage IVb metastatic gastric cancer continues to derive clinical benefit after having an observed partial response. The two other patients within cohort 2, one with stage IV colorectal cancer and one with stage IV gall bladder cancer, continue to show clinical benefit with stable disease, with no change in tumor measurements compared to baseline at over 3 months.

“We are encouraged to see the continued durable clinical benefit in patients with advanced, metastatic, unresectable HER2-positive solid tumors who had experienced up to seven prior lines of therapy in the metastatic setting, including multiple HER2 targeted therapies,” said Deyaa Adib, M.D., Chief Medical Officer of Triumvira. “The need for new treatment options for this unrelenting disease drives our efforts to bring TAC01-HER2 to the broadest patient population that may benefit from this therapy. We are pleased by the significant interest shown by our investigators in our trial and remain on track to complete enrollment in escalation cohort 4 (6 – 8 x 106 cells/kg) by the end of 2022 and expect to significantly exceed our enrollment targets. We look forward to moving forward with an identified recommended Phase 2 dose in Q1 2023.”

Benjamin L. Schlechter, M.D., GI medical oncologist at Dana-Farber Cancer Institute, and an investigator on the TACTIC-2 study, added, “These updated interim data showed compelling responses in cancer patients treated with TAC01-HER2. Patients entered the study with refractory disease and were a heavily pre-treated population that had experienced multiple lines of prior therapies. The interim safety and efficacy data show that TAC01-HER2 could potentially improve the lives of cancer patients with significant unmet medical need.”

These initial data, from 11 patients as of the data cutoff date of November 3, 2022, continue to demonstrate that TAC01-HER2 is safe and well-tolerated with no dose limiting toxicities (DLTs) in the three cohorts as assessed by the data safety monitoring committee. The most frequent adverse events (AEs) were cytopenias related to lymphodepletion chemotherapy & most serious adverse events (SAEs) were unrelated to TAC01-HER2. In cohort 3 two patients experienced grade 1 CRS and one patient experienced grade 2 CRS for which standard of care brief corrective treatment measures were instituted using antipyretics and tocilizumab.

TAC01-HER2 is a novel cell therapy that consists of genetically engineered autologous T cells expressing T-cell Antigen Coupler (TAC) that recognizes HER2. The ongoing Phase I study is actively enrolling patients with advanced, metastatic, unresectable HER2-positive solid tumors who had experienced at least two prior lines of therapy, including multiple HER2 targeted therapies.

Keep up to date with SITC 2022 news and updates using the hashtag #SITC22 and follow Triumvira on LinkedIn.

About Triumvira Immunologics
Triumvira is a clinical-stage company developing a best-in-class, rationally designed cell therapy platform based on its proprietary T cell Antigen Coupler (TAC) technology. Its lead candidate, TAC01-HER2, is being evaluated in an ongoing Phase 1/2 trial for HER2-positive solid tumors with positive initial safety and efficacy data to-date. Triumvira’s pipeline includes other compelling pre-clinical solid tumor programs targeting Claudin 18.2, GUCY2C and GPC3, among others, with anticipated IND filings over the next few years. Supporting the pipeline has been an industrialized, drug-like, approach to manufacturing, including the first-mover adoption of the Lonza Cocoon® Platform that has yielded high quality product and a very high manufacturing success rate at a lower cost compared to other autologous approaches. Building on the proof-of-concept of its clinical-stage autologous TAC01-HER2 program, Triumvira is continuing to develop and advance its gamma delta allogeneic pipeline with IND filings anticipated over the next three years.

SOURCE: Triumvira Immunologics

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