On May 31, 2023 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 that positive data from its Phase I/II trial investigating the safety and efficacy of autologous TAC01-HER2 in refractory solid tumors (TACTIC-2/NCT04727151), will be presented at the 2023 American Society Of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting, held June 2-6 in Chicago (Press release, Triumvira Immunologics, MAY 31, 2023, View Source [SID1234632294]). Benjamin L. Schlechter, MD, from Harvard Medical School, and a Senior Physician in Gastrointestinal Oncology at Dana-Farber Cancer Institute, will highlight updated clinical data demonstrating the potential of TAC01-HER2 as a targeted therapy for patients who are refractory to existing HER2-targeted therapies.

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"We are encouraged by the promising results from the TACTIC-2 trial, which demonstrate the safety and compelling clinical activity of autologous TAC01-HER2 in refractory solid tumors," said Deyaa Adib, M.D., Chief Medical Officer of Triumvira Immunologics. "These findings suggest that TAC technology has the potential to transform the treatment landscape for patients with HER2-positive gastric and esophageal cancers, offering a novel approach that harnesses the natural biology of T cells. We look forward to further exploring the therapeutic benefits of TAC01-HER2 in the phase 2 component of the trial and advancing its development towards improving patient outcomes in this population that has been deprived of significant therapeutic progress over the last 40 years."

"The interim results from the Phase I TACTIC-02 study are very promising, demonstrating a favorable safety profile for TAC01-HER2 treatment and early signals of clinical activity," stated Dr. Benjamin Schlechter, Principal Investigator of the study. "The observed disease control rate of 83% at 3 months and impressive partial responses in advanced gastric and GEJ cancer patients highlight the therapeutic potential of TAC01-HER2. These findings warrant further investigation and hold promise for addressing the therapeutic needs of patients with HER2-positive gastric and esophageal cancers."

Key Findings

Interim results from the Phase I TACTIC-02 study suggest a highly favorable safety profile for TAC-01 HER2 treatment with the potential of being an outpatient procedure.
One DLT (dose limiting toxicities) of Grade 3 pneumonitis and one Grade 3 CRS were observed at the highest dose level, both resolved with standard of care measures, without the need for ICU admission. No neurotoxicities reported to date across all cohorts.
TAC01-HER2 demonstrated early signals of clinical activity, highlighting two partial responses (in a stage IVb gastric cancer patient and a stage IV GEJ patient, at DL 2 and 4, respectively) and a disease control rate of 67% across DL2-4.
In gastric/GEJ/esophageal cancer patients, the DCR is 83%, while the ORR is 33% across DL 2-4.
Presentation Details:

Title: A Phase I/II Trial Investigating Safety and Efficacy of Autologous TAC01-HER2 in Relapsed or Refractory Solid Tumors (TACTIC-2)
Authors: Benjamin L. Schlechter, MD, Senior Physician, Instructor in Medicine, Harvard Medical School and Attending Physician, Medical Oncology, Dana-Farber Cancer Institute
Session: Developmental Therapeutics—Immunotherapy
Poster Session Display Date and Time: 6/3/2023, 8:00 AM-11:00 AM
Poster Discussion Session Date and Time: 6/3/2023, 3:00 PM-4:30 PM
Abstract Number: 2519

Abstract titles are currently available on the ASCO (Free ASCO Whitepaper) website. A copy of the presentations will be available after the closure of the meeting, under the Presentations & Publications tab of the News & Resources section of the Company’s website.