Staff, Author at Triumvira Immunologics | Engineered T Cell Therapies - Page 8 of 9

AUSTIN, Texas, and HAMILTON, Ontario – [Triumvira Immunologics](/content/ "Triumvira Immunologics"/index.html) (“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.”

AUSTIN, Texas, and HAMILTON, Ontario – [Triumvira Immunologics](/content/ "Triumvira Immunologics"/index.html) (“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

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](/content/ "Triumvira Immunologics"/index.html) (“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 10^5 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.

Introduction:

• The T cell antigen coupler (TAC) is a novel, proprietary chimeric receptor that facilitates the re‑direction of T cells to tumor cells and activates T cells by co‑opting the endogenous T cell receptor complex, with the goal to elicit a safe and durable anti‑tumor response. In preclinical models of cancer, TAC‑engineered T cells effectively eradicate tumor cells in vitro and in vivo without TAC‑related toxicities.
• TACTIC‑2 (NCT04727151) is an open‑label, multicenter phase I/II study that aims to establish safety, maximum tolerated dose (MTD), recommended phase 2 dose (RP2D), pharmacokinetic profile, and efficacy of TAC01‑HER2 in patients with HER2‑positive solid tumors (i.e. breast, lung, pancreatic, colorectal, gastric, endometrial, ovarian, and others) whom have progressed on prior anti‑cancer therapies.
• We present a clinical update from Cohorts 1 & 2 (8 participants) that highlights safety and efficacy data; the study further elucidates potential therapeutic impact to patients with HER2 overexpressed solid tumors.

AUSTIN, Texas, and HAMILTON, Ontario, Sep. 6, 2022 – [Triumvira Immunologics](/content/ "Triumvira Immunologics"/index.html) (“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

Background: Despite recent therapeutic advances for patients with breast, colorectal and gastroesophageal cancers with HER2 overexpression, there is still a significant unmet medical need for better treatment options for HER2-positive solid tumors, especially those with low or intermediate HER2 expression (1+ and 2+ by immunohistochemistry (IHC)). The T Cell Antigen-Coupler (TAC) technology is a novel way to genetically modify T cells and to redirect these T cells to target cancer antigens and to activate T cells naturally by co-opting the natural T cell Receptor (TCR).

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

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.

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.