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.”

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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.”

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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.

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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.”

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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

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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.”

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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.”

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Early signals of clinical activity observed in second dosing cohort with one partial response TAC01-HER2 was safe and well-tolerated in the first two dosing cohorts of TACTIC-2 Phase 1/2 clinical trial

AUSTIN, Texas, and HAMILTON, Ontario, Sep. 12, 2022 – 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 positive initial 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. Initial clinical data demonstrate TAC01-HER2 was well-tolerated in both dosing cohorts and early signals of clinical activity were observed in the higher of the two dosing cohorts, demonstrating a 75% disease control rate, including one partial response. These initial results were presented in a poster at the European Society for Medical Oncology (ESMO) 2022 Congress.

“Every milestone achievement bolsters our confidence as we leverage our novel, versatile TAC platform to develop a T cell therapy that is less toxic than existing T cell therapies yet effective in killing target-bearing solid tumors”

The first two dosing cohorts of the trial enrolled eight patients with advanced, metastatic, unresectable HER2-positive solid tumors who had experienced up to two prior lines of therapy including HER2 targeted therapies. Early signals of clinical activity were observed in the second dosing cohort (6-8 x 105 cells/kg) with a disease control rate of 75%. A partial response was observed in a patient with stage IVb metastatic gastric cancer who was heavily pre-treated and defined as 3+ HER2 by immunohistochemistry (IHC). CT scans taken 29-days after dosing showed a 36.5% reduction in tumor size in target lesions compared to baseline and the size of numerous metabolically active lymph nodes associated with the mass decreased. Two patients with significant disease burden within the second cohort, one with colorectal cancer and one with gall bladder cancer, have been observed with stable disease with no change in tumor measurements compared to baseline.

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