Triumvira Immunologics Announces First Patient Dosed in Phase I/II Cell Therapy Trial of TAC101-CLDN18.2 for the Treatment of Claudin 18.2+ Solid Tumors

SAN DIEGO and AUSTIN, TX and HAMILTON, ON – Feb. 5, 2024 /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 first patient has been dosed in its TACTIC-3 trial, a Phase I/II study, (NCT05862324) investigating the safety and efficacy of autologous TAC-T cell asset, TAC101-CLDN18.2, targeting Claudin 18.2+ solid tumors. TAC101-CLDN18.2 is a novel cell therapy based on genetically engineered autologous T cells expressing a T-cell Antigen Coupler (TAC) that harnesses the inherent signaling pathways of the native T cell receptor complex and targets Claudin 18.2, an epithelial transmembrane protein overexpressed in gastric cancer and several other solid tumor types.

“Claudin 18.2 is a promising target for cell therapy,” said Andreas Bader, Ph.D., Chief Scientific Officer of Triumvira Immunologics. “Among normal tissues, it is restricted to the stomach and hidden between neighboring cells. In gastric cancer and a few other solid tumors, however, it is accessible and abundantly expressed on tumor cell surfaces and, therefore, it represents a significant tumor selective opportunity to address these types of cancers.”

Triumvira Immunologics to Present Clinical Data at the 2024 ASCO Gastrointestinal Cancers Symposium

Austin, TX, Hamilton, ON and South San Francisco, CA – Dec. 19, 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 it will present two abstracts at the 2024 American Society of Clinical Oncology (ASCO) Gastrointestinal Cancers Symposium in San Francisco, California, from January 18-20, 2024. The company will showcase clinical data from its ongoing Phase I/II studies investigating the safety and efficacy of autologous TAC-T cells targeting human epidermal growth factor receptor 2 (HER2) and Claudin 18.2 (CLDN 18.2), respectively, in relapsed or refractory solid tumors (TACTIC-2 /NCT04727151, TACTIC-3 /NCT05862324).

The technology behind TAC01-HER2 and TAC01-CLDN18.2 stands as an innovative cell-based therapeutic modality, harnessing genetically engineered T cells derived autologously. These T cells are equipped with a T-cell Antigen Coupler (TAC) rationally designed to specifically recognize HER2 or CLDN18.2 within tumor cells.

Triumvira Immunologics to Present New Clinical and Preclinical Data on its TAC-T Cell Technology at SITC 2023 Annual Meeting

AUSTIN, Texas and HAMILTON, ON and SOUTH SAN FRANCISCO, Calif., Oct. 30, 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 it will participate with one oral presentation and four posters at the Society for Immunotherapy of Cancer (SITC) 2023 Annual Meeting in San Diego, California, from November 1-5. The company will showcase clinical and preclinical data across various programs, including its ongoing Phase I/II study investigating the safety and efficacy of autologous TAC-T cells targeting human epidermal growth factor receptor 2 (HER2) in relapsed or refractory solid tumors (TACTIC-2 /NCT04727151) and its CLDN18.2, GUCY2C and allogeneic TAC T cell technologies.

TAC01-HER2 is an innovative cell-based therapy that involves the utilization of genetically modified T cells derived from the patient themselves. These cells express a T-cell Antigen Coupler (TAC) which is designed to specifically recognize HER2 in tumors. In addition to the TAC01-HER2 candidate, the company is investigating TAC-GUCY2C for the treatment of colorectal cancer and TAC01-CLDN18.2 for the treatment of pancreatic ductal adenocarcinoma and gastric cancer.

Triumvira Immunologics Announces First Patient Dosed in Phase II of TACTIC-2 Cell Therapy Trial for the Treatment of HER2+ Gastric and GEJ Cancers

AUSTIN, Texas and HAMILTON, ON and SOUTH SAN FRANCISCO, Calif., Oct. 2, 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 first patient has been dosed in Phase II of its Phase I/II study TACTIC-2 (NCT04727151) investigating the safety and efficacy of autologous TAC-T cell lead asset, TAC01-HER2, in targeting HER2 in relapsed or refractory gastric and gastroesophageal junction (GEJ) tumors. TAC01-HER2 is a novel cell therapy based on genetically engineered autologous T cells expressing a T-cell Antigen Coupler (TAC) that recognizes human epidermal growth factor receptor 2 (HER2).

“This marks a significant milestone for our company, building upon the determination of the recommended Phase II dose, identifying gastric and gastroesophageal cancer patients as targets for the Phase II registration supporting study and the positive benefit we observed during the Phase I part of TACTIC-2,” said Deyaa Adib, M.D., Chief Medical Officer of Triumvira Immunologics. “Despite considerable advances in the oncology field, HER2-positive gastric and gastro-esophageal cancers remain difficult to treat, and new therapeutic options are urgently needed especially in later treatment lines in a growing patient segment. Our TAC technology offers a novel approach that works by leveraging the natural signaling pathways of endogenous TCRs and modifying T cells into TAC T cells with demonstrated success in the treatment of these tumors. We are committed to providing clinically meaningful therapeutic benefits to this patient population with high unmet medical needs.”

Triumvira Immunologics to Present Clinical Data from TACTIC-2 Trial Investigating TAC01-HER2 at ESMO 2023 Congress and AACR-NCI-EORTC International Conference

AUSTIN, Texas and HAMILTON, ON and SOUTH SAN FRANCISCO, Calif., Oct. 2, 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 it will present clinical data from its ongoing Phase I/II study investigating the safety and efficacy of autologous TAC-T cells targeting HER2 in relapsed or refractory solid tumors (TACTIC-2 /NCT04727151) at two upcoming scientific conferences: the European Society for Medical Oncology (ESMO) Congress, being held October 20-24, 2023, in Madrid, Spain, and the AACR-NCI-EORTC International Conference on Molecular Targets and Cancer Therapeutics, being held October 11-15, 2023, in Boston. TAC01-HER2 is a novel cell therapy based on genetically engineered autologous T cells expressing a T-cell Antigen Coupler (TAC) that recognizes human epidermal growth factor receptor 2 (HER2).

Triumvira Immunologics Strengthens its Leadership Team with Three Accomplished Life Sciences Executives

AUSTIN, Texas and HAMILTON, ON and SOUTH SAN FRANCISCO, Calif., July 20, 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 the strengthening of its leadership team with the appointments of Mr. Robert Williamson as President, Chief Operating Officer and member of the Board of Directors, Mr. Jeffrey Erickson as VP of Business Development, and Mr. Chris Murray as VP of Human Resources.

“The appointment of Robert as our President and Director, Chris as our VP of Human Resources, and the addition of Jeffrey to the team will be instrumental in our efforts to expand our team of experts and advance our T cell Antigen Coupler (TAC) technology and lead assets, including our novel autologous cell therapy TAC100-HER2, to late-stage clinical development,” said Paul Lammers, M.D., M.Sc., Chief Executive Officer of Triumvira. “We couldn’t be more excited to bring them on board.”

Triumvira Immunologics to Showcase Clinical Findings from TACTIC-2 Clinical Trial Assessing TAC01-HER2 at 2023 ESMO World Congress on Gastrointestinal Cancer

AUSTIN, Texas and HAMILTON, ON and SOUTH SAN FRANCISCO, Calif., June 28, 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 it 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 European Society for Medical Oncology (ESMO) World Congress on Gastrointestinal Cancer taking place in Barcelona, Spain, June 28 – July 1, 2023. The upcoming presentation will feature the latest clinical findings obtained from the ongoing Phase I/II trial of TAC01-HER2 (NCT04727151) among patients with relapsed or refractory solid tumors.

“We are honored to share our latest advancements in precision cell therapy at ESMO World Congress on Gastrointestinal Cancer. Our innovative and well-differentiated TAC01-HER2 cell therapy holds great promise in the treatment of HER2-positive solid tumors,” said Deyaa Adib, M.D., Chief Medical Officer of Triumvira Immunologics. “This phase 1 data presentation represents a significant step forward in our mission to transform cancer care through the natural potential of T cells. We look forward to contributing to the scientific dialogue and working towards a future where targeted T-cell therapeutics redefine the landscape of cell therapies in solid tumors, specifically in late-stage gastric and esophageal cancers which have been an area of significant unmet need for a long time.”

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.