Triumvira Immunologics Highlights Positive Phase 1 Clinical Data on TAC01-HER2 in Solid Tumors at ASCO 2023 Annual Meeting

AUSTIN, Texas and HAMILTON, ON and SOUTH SAN FRANCISCO, Calif., May 31, 2023 /PRNewswire/ — 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, today announced 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) Annual Meeting, held June 2-6 in Chicago. 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.

“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 have been deprived of significant therapeutic progress over the last 40 years.”

Triumvira Immunologics to Present Clinical Data from Phase I/II Trial TACTIC-2 Investigating TAC01-HER2 at the 2023 ASCO Annual Meeting

AUSTIN, Texas and HAMILTON, ON and SOUTH SAN FRANCISCO, Calif., May 16, 2023 /PRNewswire/ — 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, today announced that the Company will be presenting clinical data on its lead asset TAC01-HER2 for the treatment of human epidermal growth factor receptor 2 (HER2) positive solid tumors at the 2023 American Society Of Clinical Oncology (ASCO) Annual Meeting, taking place in Chicago, IL, June 2-6. The presentation by Benjamin L. Schlechter, MD, from Harvard Medical School and a Senior Physician in Gastrointestinal Oncology at the Dana-Farber Cancer Institute, will highlight updated clinical data from the ongoing Phase I/II trial of TAC01-HER2 (NCT04727151) in patients with relapsed or refractory solid tumors.

“We are excited to present the latest clinical data from our Phase I/II trial of TAC01-HER2 in refractory solid tumors at the upcoming ASCO meeting as a poster and a poster discussion. The availability of updated clinical data will offer remarkable insights into the potential of TAC01-HER2 as a targeted therapy for patients who are refractory to existing HER2 targeted therapies,” said Deyaa Adib, M.D., Chief Medical Officer of Triumvira Immunologics. “We are committed to delivering innovative solutions for cancer patients and addressing critical unmet medical needs and look forward to sharing the updated findings with the oncology community at this prestigious scientific meeting.”

Triumvira Immunologics Presents Promising Data on TAC T Cells for the Treatment of HER2-overexpressing Solid Tumors at the 2023 AACR Annual Meeting

AUSTIN, Texas and HAMILTON, ON and SOUTH SAN FRANCISCO, Calif., April 18, 2023 /PRNewswire/ — Triumvira 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.

Triumvira Immunologics to Present New Data on its TAC T Cell Autologous and Allogeneic Products and the Ongoing Phase I/II Solid Tumor Trial at the 2023 AACR Annual Meeting

AUSTIN, Texas & SOUTH SAN FRANCISCO, Calif. & HAMILTON, Ontario–(BUSINESS WIRE)–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 solid tumors, today announced that the Company will be presenting preclinical and clinical data on its lead asset TAC01-HER2 for the treatment of human epidermal growth factor receptor 2 (HER2) positive solid tumors at the 2023 American Association for Cancer Research (AACR) Annual Meeting taking place in Orlando, April 14-19. The presentations will include updated clinical data and product characterization from the ongoing Phase I/II trial of autologous TAC01-HER2 (NCT04727151) in patients with solid tumors and preclinical data on an allogeneic HER2-TAC T cell product.

“We are pleased to present additional validation of our lead clinical program TAC01-HER2, currently in Phase I/II trials, supporting the efficiency of our proprietary Cocoon® platform to manufacture potent autologous TAC01-HER2 cells using leukocytes from cancer patients,” said Deyaa Adib, M.D., Chief Medical Officer of Triumvira Immunologics. “Interim results will also be presented from our ongoing Phase I/II trial investigating the safety and efficacy of autologous TAC01-HER2 in HER2+ refractory solid tumors demonstrating a favorable safety profile and promising clinical activity as evident by reduction of measurable disease and prevention of fast cancer progression in the majority of patients enrolled in the Phase I trial. Further, we will present new preclinical data from our allogeneic T cell-based products in development demonstrating their potential to avoid graft versus host disease.”

Triumvira Immunologics Establishes Collaboration with Merck to Evaluate TAC01-HER2 Cell Therapy in Combination with KEYTRUDA® (pembrolizumab) in Patients with HER2-positive Solid Tumors

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

AUSTIN, Texas & SOUTH SAN FRANCISCO, Calif. & HAMILTON, Ontario–(BUSINESS WIRE)–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 solid tumors, today announced a clinical trial collaboration and supply agreement with Merck (known as MSD outside the U.S. and Canada). Triumvira’s ongoing TACTIC-2 trial will evaluate the use of its novel autologous cell therapy TAC01-HER2 as a monotherapy but also in combination with Merck’s anti-PD-1 therapy KEYTRUDA® (pembrolizumab) for the treatment of HER2-positive solid tumors.

“We believe the addition of an immune checkpoint inhibitor, such as KEYTRUDA, to TAC01-HER2 will effectively release inhibitory PD-L1/PD1 signaling in T cells, potentially leading to improved and durable therapeutic responses, said Paul Lammers, M.D., M.Sc., Chief Executive Officer of Triumvira. We are pleased to work collaboratively with Merck to explore the potential of this approach to treat relapsed or refractory solid tumors and bring new drug therapies to patients who do not respond to existing treatments.”

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, Texas & SOUTH SAN FRANCISCO, Calif. & HAMILTON, Ontario–(BUSINESS WIRE)–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.

Triumvira Immunologics Demonstrates Strength of Preclinical Research Pipeline for Gastric and Colorectal Cancers in Three Posters at SITC 2022

AUSTIN, Texas & SOUTH SAN FRANCISCO, Calif. & HAMILTON, Ontario–(BUSINESS WIRE)–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 preclinical data for its investigational TAC-T cell therapies CLDN18.2-TAC T and GUCY2C-TAC T, and data on HER2-specific TAC-T products. Data was shared in three posters at the Society for Immunotherapy of Cancer (SITC) 37th Annual Meeting being held virtually and in person in Boston.

“We are encouraged by our preclinical results to date, which further demonstrate that our proprietary T cell Antigen Coupler (TAC) technology is versatile, and can achieve effective and specific tumor targeting,” said Andreas Bader, Ph.D., Chief Scientific Officer of Triumvira. “We are excited to be one step closer to moving CLDN18.2-TAC T towards entering clinical development. The data showed that CLDN18.2-TAC T and GUCY2C-TAC T could be an effective treatment for hard-to-treat solid tumors.”

Triumvira Immunologics to Present Clinical and Preclinical Updates at Society for Immunotherapy of Cancer (SITC) 37th Annual Meeting

AUSTIN, Texas, and HAMILTON, Ontario – 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 that it will present data from its ongoing clinical and preclinical programs at the upcoming Society for Immunotherapy of Cancer (SITC) 37th Annual Meeting, being held Nov. 10-12, 2022, in Boston and virtually. The presentations will include updated clinical data from its Phase 1/2 trial of TAC01-HER2 in patients with solid tumors and preclinical data on T cell therapy candidates TAC01-CLDN18.2 and GUCY2C-TAC T.

Details of presentations:

Title: A Phase I/II Trial Investigating Safety and Efficacy of Autologous TAC T Cells Targeting HER2 in Relapsed or Refractory Solid Tumors
Abstract #: 760

Title: Development of GUCY2C-TAC T cells for the treatment of colorectal cancer
Abstract #: 201

Title: Evidence for durable anti-tumor responses by TAC-T cells in preclinical models of solid tumors
Abstract #: 261

Title: Preclinical studies of TAC01-CLDN18.2, an autologous Claudin 18.2-directed TAC T cell therapy, in the treatment of gastric cancer
Abstract #: 294

Triumvira Immunologics Appoints Life Sciences Industry Leader Robert Williamson as President and Chief Business Officer

AUSTIN, Texas, and HAMILTON, Ontario – 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 the appointment of Robert Williamson as President and Chief Business Officer. Mr. Williamson will lead business development and strategy for Triumvira, and will work within Triumvira’s leadership team to establish new value-creating partnerships, drive long-term strategic plans, and advance fundraising activities.

Mr. Williamson brings more than 25 years of experience in the biotechnology sector, leading company business development and financing efforts through partnerships, private funding, and public capital markets. His accomplishments include orchestrating the exits of numerous biotech companies, including guiding the growth, IPO, financing, commercial ramp-up and sale of Pharmasset to Gilead for $11 billion.

“We are delighted to welcome Rob to the team and look forward to working together to advance Triumvira’s mission on the heels of our recent clinical accomplishments and as we advance our robust pipeline,” said Paul Lammers, M.D., M.Sc., Chief Executive Officer of Triumvira. “Rob has a long track record of building companies and delivering value for various stakeholders, and he brings tremendous experience and perspective to our leadership team.”

Triumvira Immunologics Announces Expansion of Cell Therapy Manufacturing Capabilities to Facility in South San Francisco

AUSTIN, Texas, and HAMILTON, Ontario – 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 a multi-year agreement with AmplifyBio to use its facilities in South San Francisco, Calif. for Triumvira to manufacture its own cell therapy candidates within the company’s pipeline.

The advanced research and manufacturing space features an FDA-compliant GMP facility and will be staffed by Triumvira technical operations experts in cell therapy manufacturing, with plans for additional personnel in the coming years. Triumvira expects the facility to be fully operational in 2023.

“Triumvira’s modular TAC manufacturing process offers the ability to integrate quickly and effectively into this new facility as well as potentially into additional GMP spaces,” said Donna Rill, Chief Technology Officer at Triumvira. “Our newly expanded manufacturing team also brings the deep technical expertise required to bring forward TAC T cell therapies as a potential new class of medicines.”