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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CAR T cells are the most popular strategy to hit the solid tumor-selective target, but companies are using at least five other methods

By Danielle Golovin / BioCentury Staff Writer
June 23, 2022

CAR T cells are the most popular strategy to hit the solid tumor-selective target, but companies are using at least five other methods.

At least 17 cell therapy programs are targeting solid tumor-selective HER2, 10 of which are CAR T cells. Companies are also expressing HER2 CARs on other cell types such as NK cells, myeloid cells, and macrophages.

CAR T cell therapies have been highly effective against hematological malignancies, but solid tumors have been more challenging. Overcoming the major obstacles, including a lack of highly tumor-selective solid tumor targets, was a major theme at the American Association for Cancer Research (AACR) annual meeting in April.

Clinical-stage biotech to implement a unified platform with a single data fabric versus point solutions

AUSTIN, Texas, and HAMILTON, Ontario, May 31, 2022 – L7 Informatics, the leader in DATA+INTELLIGENCE for the scientific enterprise, and Triumvira Immunologics (“Triumvira”) today announced an agreement to implement L7|ESP at Triumvira to enhance the digitalization of its manufacturing of next-generation cell therapies. Triumvira is 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.

“With early incorporation of scalable automation, we can facilitate the availability of treatment to patients and decrease the time to market. Having a unified platform like L7|ESP, we can avoid having to implement several separate point solutions, which in turn saves us valuable time and energy.

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Triumvira to initiate enrollment of second cohort in ongoing Phase 1/2 trial of TAC01-HER2 following data safety monitoring committee’s successful review of safety data from first cohort

AUSTIN, Texas, and HAMILTON, Ontario, April 10, 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 it will present two posters at the American Association for Cancer Research (AACR) Annual Meeting, taking place April 8-13, 2022 in New Orleans. The company will present an update from its ongoing TACTIC-2 clinical trial evaluating TAC01-HER2 in patients with HER2-positive solid tumors and new preclinical proof-of-concept data for its gastric cancer candidate, TAC-Claudin 18.2 (CLDN18.2).

“We plan to build on this success through an eventual IND filing for CLDN18.2 and look forward to expanding our novel platform to address additional targets.”

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AUSTIN, Texas, and HAMILTON, Ontario, March 17, 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 the completion of an extension of its Series A financing, bringing the total round to approximately $100 million. The Series A extension featured new investors, including significant participation from B Capital Group, along with ATEM Capital, the Myeloma Investment Fund, the Multiple Myeloma Research Foundation’s venture philanthropy subsidiary, and others, joined by significant participation from existing investors, Leaps by Bayer, the impact investment unit of Bayer AG, and Northpond Ventures.

“Our proprietary TAC technology platform offers an innovative approach to developing novel autologous and allogeneic treatments for solid tumors, and we are excited to advance our pipeline through 2022 and beyond.”

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Novel CLDN18.2-TAC T cell candidate effectively eradicated Claudin 18.2-expressing gastric tumor cells in vitro and in vivo

AUSTIN, Texas, and HAMILTON, Ontario, November 13, 2021 – 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 formed its inaugural Scientific Advisory Board (SAB), comprising four leading scientists and physicians. Jonathan Bramson, Ph.D., Scientific Co-Founder of Triumvira, Professor of Pathology and Molecular Medicine, and Vice Dean of Research at McMaster University, will serve as chair of the SAB.

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Novel CLDN18.2-TAC T cell candidate effectively eradicated Claudin 18.2-expressing gastric tumor cells in vitro and in vivo

AUSTIN, Texas, and HAMILTON, Ontario, November 13, 2021 – Triumvira Immunologics (“Triumvira”), a clinical-stage company developing novel, targeted autologous and allogeneic T cell therapeutics that do not require gene editing and co-opt the natural biology of T cells to treat patients with solid tumors, today announced the presentation of preclinical data from its proof-of-concept study in gastric cancer. These new data demonstrate that Triumvira’s novel T cell antigen coupler (TAC)-T cell candidate targeting Claudin 18.2 (CLDN18.2) effectively eradicates CLDN18.2-expressing gastric tumor cells in vitro and in vivo. The results will be presented in a poster presentation today at the Society for Immunotherapy of Cancer (SITC) 36th Annual Meeting, taking place November 10-14, 2021, virtually and in-person at the Walter E. Washington Convention Center in Washington, D.C.

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AUSTIN, Texas & 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 it has appointed Deyaa Adib, M.D., to serve as the company’s Chief Medical Officer, effective immediately. Dr. Adib will report to President and CEO Dr. Paul Lammers and will succeed Dr. Sabine Chlosta.

As a seasoned industry leader, Dr. Adib has over 24 years of medical oncology experience in the biotechnology and pharmaceutical industries, including seven successful registrations across solid tumor and hematologic malignancy indications. He previously served as acting chief medical officer at Rain Therapeutics, where he built the oncology portfolio leading to a successful IPO, and vice president of late-stage development at Blueprint Medicines advancing the development of avapritinib approved for gastrointestinal stromal tumor and advanced systemic mastocytosis. Dr. Adib also served as global therapeutics head for solid tumors at Baxalta, advancing the development of imalumab in colorectal cancer, non-small cell lung cancer (NSCLC), and ovarian cancer, and licensing nanoliposomal irinotecan that was subsequently approved for pancreatic cancer. In this role, he also led the efforts to secure licensing and development of a CD-19 target with Precision Biosciences in B cell malignancies and PD1, LAG3, TIM3 solid tumor targets with Symphogen, a Servier company. He also served as head of hematologic malignancies at ARIAD Pharmaceuticals (now part of Takeda) leading the global clinical program for ponatinib dose-finding and line extension in chronic myeloid leukemia.

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TACTIC-2 marks first in-human use of TAC-T cell therapy Phase 1/2 clinical trial will evaluate TAC01-HER2, Triumvira’s lead candidate, in patients with HER2-overexpressing solid tumors First patient dosed at MD Anderson Cancer Center in Houston, Texas AUSTIN, Texas & HAMILTON, Ontario–(BUSINESS WIRE)–Triumvira Immunologics (“Triumvira”) today announced that the first patient has been dosed as part of the TACTIC-2 trial evaluating the company’s lead candidate, TAC01-HER2, an autologous T cell therapy for the treatment of human epidermal growth factor receptor 2 (HER2) positive solid tumors. Triumvira, a clinical-stage company, is developing novel, targeted autologous, and allogeneic T cell therapeutics that co-opt the natural biology of T cells to treat patients with solid and liquid tumors. The company’s proprietary T cell Antigen Coupler (TAC) platform technology activates natural T cell functions differently from other cell therapies such as Chimeric Antigen Receptor T cell (CAR-T) and engineered T cell receptor therapies.

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