Author: Staff

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

Posted on by Staff

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.

A Phase I/II Trial Investigating Safety and Efficacy of Autologous T Cell Antigen-Coupler (TAC) T Cells Targeting HER2 in Relapsed or Refractory Solid Tumors (TACTIC-2) (ESMO Report)

Posted on by Staff

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.

View/Download Poster

A Phase I/II Trial Investigating Safety and Efficacy of Autologous T Cell Antigen-Coupler (TAC) T Cells Targeting HER2 in Relapsed or Refractory Solid Tumors (TACTIC-2)

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

Posted on by Staff

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

A Phase I/II Trial Investigating Safety and Efficacy of Autologous T Cell Antigen-Coupler (TAC) T Cells Targeting HER2 in Relapsed or Refractory Solid Tumors (TACTIC-2)

Posted on by Staff

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).

View/Download Poster

A Phase I/II Trial Investigating Safety and Efficacy of Autologous T Cell Antigen-Coupler (TAC) T Cells Targeting HER2 in Relapsed or Refractory Solid Tumors (TACTIC-2)

CAR T cells headline HER2 cell therapy pipeline

Posted on by Staff

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

Posted on by Staff

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.

Triumvira Immunologics to Present Two Posters Covering Ongoing Phase 1/2 Solid Tumor Trial and New Preclinical Gastric Cancer Data at AACR Annual Meeting 2022

Posted on by Staff

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.”

Triumvira Immunologics Completes Extension of Series A Financing, for Total Round of Approximately $100 Million

Posted on by Staff

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.”

Triumvira Immunologics Establishes Scientific Advisory Board

Posted on by Staff

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.