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.”

Triumvira Immunologics to Participate in Four Upcoming Healthcare Investor Conferences in October and November 2022

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 solid tumors, today announced that Senior Management will participate in four upcoming healthcare investor conferences.

  • Oppenheimer Private Company Showcase: The Next Wave: presentation at 2:35 pm PT on Tuesday, October 18th and available for investor meetings
  • Bank of America Healthcare Life Sciences Private Company Conference: available for in-person investor meetings on Thursday, October 20th
  • Wells Fargo Private Biotech Symposium: available for virtual investor meetings on Wednesday, November 2nd
  • Stifel 2022 Healthcare Conference: presentation on Wednesday, November 16th at 9:10 am ET and available for investor meetings

Triumvira Immunologics Presents Initial HER2-Positive Solid Tumor Clinical Data at ESMO

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.

Triumvira Immunologics to Present Interim Clinical Data from Ongoing Phase 1/2 Trial with T Cell Therapy TAC01-HER2 at European Society for Medical Oncology 2022 Congress

AUSTIN, Texas, and HAMILTON, Ontario, Sep. 6, 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 that it will present interim clinical data from its ongoing TACTIC-2 clinical trial (NCT04727151) for TAC01-HER2 in a poster presentation at the upcoming European Society for Medical Oncology (ESMO) Congress, being held Sept. 9-13, 2022 in Paris, France. TAC01-HER2 is a novel cell therapy that consists of genetically engineered autologous T cells expressing T-cell Antigen Coupler (TAC) that recognizes human epidermal growth factor receptor 2 (HER2).

Details of presentation:

Title: A Phase I/II Trial Investigating Safety and Efficacy of Autologous TAC T Cells Targeting HER2 in Relapsed or Refractory Solid Tumors
Presenter: Benjamin L. Schlechter, M.D., GI-Medical Oncology at Dana-Farber Cancer Institute
Abstract #: 778TiP
Date: Monday, Sept. 12, 2022
Time: 11:00 a.m. – 12:00 p.m. CEST
Location: Paris Expo Porte de Versailles, Hall 4

CAR T cells headline HER2 cell therapy pipeline

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.

Triumvira trial stages image

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.

HER2 is by far the most popular of 19 targets for solid tumor CAR T programs in the clinic, with at least seven. The well-validated target has also served as a testing ground for next-generation antibody therapies including antibody-drug conjugates and bispecifics.

The three other clinical cell therapies against HER2 are a TAC T cell from Triumvira Immunologics Inc., a CAR macrophage from Carisma Therapeutics Inc. and an antibody conjugated to an NK cell from Acepodia Inc.

Two of the clinical programs are in Phase I/II testing, while the rest are in Phase I.

Triumvira HER2 cell therapy pipeline image

Triumvira’s TAC T cells are one of the most advanced programs. They incorporate a  “T cell antigen coupler” receptor, a multidomain chimeric molecule that works directly with the cells’ natural T cell receptor (TCR) to help the cell recognize and attack cancer cells.

The company’s TAC01-HER2 cells have a TAC receptor comprising a HER2 binding domain, a central CD3 binding domain that interacts with the TCR, and CD4 co-receptor intracellular domain that anchors the TAC in the cell membrane and either activates or silences the T cell depending on the presence of a cancer antigen.

The other program in Phase I/II testing is CAR T cell LEU-001 from Leucid Bio Ltd. Its CAR construct recognizes eight distinct molecular targets according to its website, which includes homo- and heterodimers formed by the ErbB receptors, including HER2. The company has treated 18 patients with head and neck cancer, and 10 achieved stable disease.

At least six CAR T programs are in Phase I testing, and Refuge Biotechnologies Inc. has three preclinical assets, each with different gene modifications.

Other cell types with HER-targeting CARs include macrophages. Carisma believes using CAR macrophages solves the three major problems of CAR T therapies: insufficient trafficking into tumor cells, tumor antigen heterogeneity, and an immunosuppressive microenvironment. However, the company has so far provided little clinical data in support.

Acepodia is chemically conjugating mAbs to NK and other immune cells via complementary DNA linkers. Its first clinical product, ACE1702, incorporates anti-HER2 mAb trastuzumab.

The company reported interim Phase I data in September from a dose-escalation study with eight patients, showing one patient achieved a partial response at a dose of 3 billion cells per cycle.

Acepodia was founded in 2016 with global rights to components of the antibody-cell conjugation technology from Carolyn Bertozzi’s lab at the University of California Berkeley. The company told BioCentury that avoiding genetic engineering will lower its manufacturing costs.

Three companies have preclinical CAR NK cell programs, while Myeloid Therapeutics Inc. is pioneering CAR myeloid cells.

 

L7 Informatics and Triumvira Immunologics Announce Agreement to Digitalize Manufacturing of Next-Generation Cell Therapies

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.