AUSTIN, TX, USA and HAMILTON, Canada and SOUTH SAN FRANCISCO, CA, USA I April 18, 2023 ITriumvira Immunologics, a clinical-stage company developing novel, targeted autologous and allogeneic T cell therapeutics, today announced the details of the Company’s presentation at the 2023 AACR Annual Meeting on its lead asset, TAC01-HER2, for the treatment of human epidermal growth factor receptor 2 (HER2) positive solid tumors. The presentations will include updated clinical data from the ongoing TACTIC-2 trial of TAC01-HER2 (NCT04727151) in patients with solid tumors and preclinical data on an allogeneic HER2-TAC T cell product.

Presentation details:

Title: A Phase I/II Trial Investigating Safety and Efficacy of Autologous TAC01-HER2 in Relapsed or Refractory Solid Tumors

Authors: Ecaterina E. Dumbrava, MD, Daniel Olson, MD, Samuel Saibil, MD, Brooke Pieke, Mridula A. George, MD, Riemke Bouvier, Kelly Gruber, Kara Moss, Nathan Ternus, Maria Apostolopoulou, Deyaa Adib, MD, and Benjamin L. Schlechter, MD.

Session: Phase II Clinical Trial 2
Date and Time: Tuesday, April 18, 2023, from 9 a.m. to 12:30 p.m. EDT
Abstract Number: CT234

Key findings:

  • Recommended phase 2 dose reached at cohort 4 (6-8 x 10^6 Cells/kg)
  • TAC01-HER2 obtained a disease control rate of 67% in heavily pretreated patients with solid tumors in patients who failed all standard of care therapies.
  • In gastric/GEJ/esophageal patients, the DCR is 83% at 3 months while the ORR is 33% across DL 2-4 which exceeds the current standard of care of 4% ORR
  • Interim results from the Phase I TACTIC-2 study suggest acceptable and manageable safety for autologous TAC-01 HER2 therapy.
  • Phase II trial enrollment of gastric and gastro-esophageal junction cancer patients will begin in 2H23 including a combination cohort to demonstrate the add on benefit of TAC-T cells to an immune check point inhibitor in gastric and gastro-esophageal junction cancer patients to develop a potentially chemo sparing regimen in this 3rd line and later cancer population.

Title: Patient-derived TAC01-HER2 TAC T cells produced in Cocoon® Platform are highly functional in models of solid tumors

Authors: Ling Wang, Stacey X. Xu, Tania Benatar, Ritu R. Randhawa, Philbert Ip, Prabha Lal, Thanyashanthi Nitya-Nootan, Laura Shaver, Heather MacGregor, Suzy Prosser, Sadhak Sengupta, Christopher W. Helsen, and Andreas G. Bader

Session: Adoptive Cell Therapy 2
Date and Time: Monday, April 17, 2023, from 1:30 p.m. to 5 p.m. EDT
Abstract Number: 3188

Key findings: 

  • Patient-derived TAC01-HER2 products consisted of a high percentage of memory T cells similar to products generated from healthy donors with significant proportions of CD4 and CD8 T cells.
  • In a 5-day in vitro potency assay, patient-derived products showed effective tumor cell killing response similar to healthy-donor derived TAC T cells.
  • Intravenous administration of patient-derived TAC01-HER2 in mice led to complete tumor clearance, indicating that patient-derived TAC01-HER2 products are highly functional.

Title: Preclinical characterization of allogeneic Vγ9Vδ2 HER2-TAC T cells for the treatment of HER2-positive solid tumors

Authors: Suzanna L. Prosser, Stacey X. Xu, Ling Wang, Ritu R. Randhawa, Sailaja Pirati, Laura Ravensbergen, Seungmi Yoo, Miyoung Jung, Laurentia Gheorghiu, Angel Gomez, Gurleen Sandhu, Chris Ayers, Donna Rill, Christopher W. Helsen, Andreas G. Bader.

Session: CAR T-cell Therapy 1
Date and Time: Monday, April 17, 2023, from 9 a.m. to 12:30 p.m. EDT
Abstract Number: 1773

Key findings:

  • HER2-TAC γδ (gamma/delta) T cells selectively react to and kill HER2-expressing tumor cells in co-culture at low effector-to-target ratios, indicating strong functionality.
  • Intravenous administration of γδ T cells results in effective tumor eradication in mouse models, similar to TAC01-HER2 (produced in αβ T cells) and without showing signs of toxicity.

“We are delighted to present additional data on safety and efficacy of our lead autologous program TAC01-HER2, currently in Phase I/II trials, demonstrating the potential of our follow-on allogeneic T cell-based products that do not cause graft versus host disease, and new data about the Cocoon® platform to manufacture potent autologous TAC01-HER2 cells using patients’ leukocytes,” said Deyaa Adib, M.D., Chief Medical Officer of Triumvira Immunologics. “Additionally, early results from our ongoing Phase I/II trial investigating the safety and efficacy of autologous TAC01-HER2 in relapsed or refractory solid tumors demonstrates acceptable safety and promising clinical activity in delaying cancer progression and regression of target tumor lesions in the majority of patients treated.”

Abstracts are currently available on the AACR website. A copy of the presentations will also be available on the Company’s website on April 19.

About Triumvira Immunologics

Triumvira Immunologics, Inc. (“Triumvira”) is a clinical-stage company developing unique, non-gene edited, first-in-class targeted autologous and allogeneic T cell therapeutics that co-opt the natural biology of T cells to treat patients with solid tumors. The company’s proprietary T cell Antigen Coupler (TAC) technology is a robust and versatile platform that activates natural T cell functions differently from cell therapies such as CAR-T and engineered T cell receptor (TCR) therapies. Triumvira is headquartered in Austin, Texas with research facilities in Hamilton, Ontario, and San Francisco, California.

SOURCE: Triumvira Immunologics