Author: Staff

A Phase I/II Trial Investigating Safety and Efficacy of Autologous TAC01-HER2 in Relapsed or Refractory Solid Tumors (TACTIC-2)

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 of eliciting a safe and durable
anti-tumor response. In preclinical models, TAC-engineered T cells effectively eradicate tumor cells in vitro and in vivo
without toxicities typically associated with engineered T cell products. TAC01-HER2 is an autologous T-cell product
comprising T cells expressing the HER2 TAC, which specifically recognizes HER2+ cells.

• 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 by immunohistochemistry that are 1+, 2+, or 3+ (i.e. breast, lung, pancreatic, colorectal, gastric,
endometrial, ovarian, and others) who have progressed on prior anti-cancer therapies.

• We present updated preliminary data from Cohorts 1-4 (20 participants) that highlights safety and efficacy data; the study
further elucidates potential therapeutic impact on patients with HER2 overexpressed solid tumors.

View/Download Poster

Triumvira SITC CL 654 poster image

Development of GUCY2C-TAC T Cells for the Treatment of Colorectal Cancer

Posted on by Staff

ABSTRACT

Background
The T cell antigen coupler (TAC) is a novel, proprietary chimeric receptor that facilitates the redirection of T cells to tumor cells and activates T cells by co-opting the endogenous T cell receptor complex with the goal of eliciting safe and durable anti-tumor responses. TAC01-HER2, a first-in-class, autologous TAC T cell product targeting HER2 (ERBB2), has entered a phase I/II clinical trial in patients with HER2-positive solid tumors. Here we present results from a new TAC T product targeting guanylyl cyclase 2C (GUCY2C). GUCY2C belongs to a family of membrane-bound mucosal guanylate cyclase receptors which are normally expressed on the apical brush border of intestinal epithelia, a site inaccessible to T cells. In cancer, however, GUCY2C is frequently overexpressed in primary and metastatic colorectal carcinomas, designating it a favorable antigen for specific targeting of tumor cells via TAC T cells. Using both in vitro and in vivo assays, we selected the top 2 GUCY2C-TAC performers out of 34 candidates, which demonstrated strong and specific activity of GUCY2C-targeted TAC T cells against GUCY2C-expressing tumor models.

Materials and Methods
The top 2 GUCY2C-TAC constructs were modified to improve efficacy by mutation of the CD3 binding domain and humanization of the nanobody, antigen binding domain. These new GUCY2CTACs were functionally characterized using various in vitro and in vivo assays. In vitro assays included proliferation as well as cytotoxicity via real-time microscopy co-culture assays. In vivo studies examined the anti-tumor effect of these GUCY2C-TACs in both liquid and solid tumor models.

Results
The GUCY2C-TAC T cells showed strong specific activation when co-cultured with a variety of cancer cells expressing GUCY2C in vitro. The proliferation of the GUCY2C-TAC T cells was induced upon coculture with naturally expressing GUCY2C target cell lines as well as GUCY2C-engineered cell lines. In vitro, cytotoxicity assay demonstrated a strong anti-GUCY2C response and killing of GUCY2C-expressing target cell lines. Intravenous administration of GUCY2C-TAC T cells in mice carrying GUCY2C-positive tumor xenografts led to a favorable anti-tumor response.

Conclusions
The in vitro and in vivo data confirm the strong and specific activity of humanized nanobody GUCY2C targeted TAC T cells against GUCY2C-expressing tumor cells.

View/Download Poster

riumvira SITC RD 347 poster image

Triumvira Immunologics to Present New Clinical and Preclinical Data on its TAC-T Cell Technology at SITC 2023 Annual Meeting

Posted on by Staff

AUSTIN, Texas and HAMILTON, ON and SOUTH SAN FRANCISCO, Calif., Oct. 30, 2023 /PRNewswire/ — Triumvira Immunologics, 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 participate with one oral presentation and four posters at the Society for Immunotherapy of Cancer (SITC) 2023 Annual Meeting in San Diego, California, from November 1-5. The company will showcase clinical and preclinical data across various programs, including its ongoing Phase I/II study investigating the safety and efficacy of autologous TAC-T cells targeting human epidermal growth factor receptor 2 (HER2) in relapsed or refractory solid tumors (TACTIC-2 /NCT04727151) and its CLDN18.2, GUCY2C and allogeneic TAC T cell technologies.

TAC01-HER2 is an innovative cell-based therapy that involves the utilization of genetically modified T cells derived from the patient themselves. These cells express a T-cell Antigen Coupler (TAC) which is designed to specifically recognize HER2 in tumors. In addition to the TAC01-HER2 candidate, the company is investigating TAC-GUCY2C for the treatment of colorectal cancer and TAC01-CLDN18.2 for the treatment of pancreatic ductal adenocarcinoma and gastric cancer.

Phase 2 of TACTIC-2 Begins Dosing TAC01-HER2 in HER2+ Gastric/GEJ Cancer

Posted on by Staff

From Targeted Oncology
TAC01-HER2, an autologous TAC-T cell lead asset made to target HER2 in relapsed or refractory gastric and gastroesophageal junction tumors, is being further evaluated in phase 2 of the TACTIC-2 study.

The first patient with relapsed or refractory HER2-positive gastric and gastroesophageal junction (GEJ) tumors has been dosed with TAC01-HER2 in phase 2 of the phase 1/2 TACTIC-2 (NCT04727151) study.1

TAC01-HER2 is an autologous TAC-T cell lead asset being developed to target HER2 in relapsed or refractory gastric and GEJ tumors. The novel cell therapy is based on genetically engineered autologous T cells expressing a T-cell antigen coupler which recognizes HER2.

Triumvira Immunologics Begins Phase II Trial of T-Cell Therapy in HER2-Positive Gastric Cancer

Posted on by Staff

From Precision Medicine Online
NEW YORK – Triumvira Immunologics said on Thursday it had begun treating patients in a Phase II trial of its autologous T-cell therapy, TAC01-HER2, in HER2-positive gastric and gastroesophageal junction cancers.

The firm began the potentially registrational Phase II portion of the TACTIC-2 study, which is evaluating TAC01-HER2 as a monotherapy and in combination with Merck’s Keytruda (pembrolizumab) in HER2-positive gastric cancers. Deyaa Adib, chief medical officer of Triumvira Immunologics, said in a statement that these tumor types were identified based on positive results from the Phase I portion of the study in solid tumors.

Triumvira Immunologics Announces First Patient Dosed in Phase II of TACTIC-2 Cell Therapy Trial for the Treatment of HER2+ Gastric and GEJ Cancers

Posted on by Staff

AUSTIN, Texas and HAMILTON, ON and SOUTH SAN FRANCISCO, Calif., Oct. 2, 2023 /PRNewswire/ — Triumvira Immunologics, 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 first patient has been dosed in Phase II of its Phase I/II study TACTIC-2 (NCT04727151) investigating the safety and efficacy of autologous TAC-T cell lead asset, TAC01-HER2, in targeting HER2 in relapsed or refractory gastric and gastroesophageal junction (GEJ) tumors. TAC01-HER2 is a novel cell therapy based on genetically engineered autologous T cells expressing a T-cell Antigen Coupler (TAC) that recognizes human epidermal growth factor receptor 2 (HER2).

“This marks a significant milestone for our company, building upon the determination of the recommended Phase II dose, identifying gastric and gastroesophageal cancer patients as targets for the Phase II registration supporting study and the positive benefit we observed during the Phase I part of TACTIC-2,” said Deyaa Adib, M.D., Chief Medical Officer of Triumvira Immunologics. “Despite considerable advances in the oncology field, HER2-positive gastric and gastro-esophageal cancers remain difficult to treat, and new therapeutic options are urgently needed especially in later treatment lines in a growing patient segment. Our TAC technology offers a novel approach that works by leveraging the natural signaling pathways of endogenous TCRs and modifying T cells into TAC T cells with demonstrated success in the treatment of these tumors. We are committed to providing clinically meaningful therapeutic benefits to this patient population with high unmet medical needs.”

Triumvira Immunologics to Present Clinical Data from TACTIC-2 Trial Investigating TAC01-HER2 at ESMO 2023 Congress and AACR-NCI-EORTC International Conference

Posted on by Staff

AUSTIN, Texas and HAMILTON, ON and SOUTH SAN FRANCISCO, Calif., Oct. 2, 2023 /PRNewswire/ — Triumvira Immunologics, 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 clinical data from its ongoing Phase I/II study investigating the safety and efficacy of autologous TAC-T cells targeting HER2 in relapsed or refractory solid tumors (TACTIC-2 /NCT04727151) at two upcoming scientific conferences: the European Society for Medical Oncology (ESMO) Congress, being held October 20-24, 2023, in Madrid, Spain, and the AACR-NCI-EORTC International Conference on Molecular Targets and Cancer Therapeutics, being held October 11-15, 2023, in Boston. TAC01-HER2 is a novel cell therapy based on genetically engineered autologous T cells expressing a T-cell Antigen Coupler (TAC) that recognizes human epidermal growth factor receptor 2 (HER2).

The Top 25 Healthcare Technology Leaders of Austin for 2023

Posted on by Staff

From The Healthcare Technology Report
The Healthcare Technology Report is pleased to announce The Top 25 Healthcare Technology Leaders of Austin for 2023. Undoubtedly, Austin stands as a bastion of health and well-being. Its extensive network of hiking, biking, and running trails, complemented by a state-of-the-art velodrome catering to cycling enthusiasts, reflects the city’s unwavering dedication to its residents’ physical fitness.

This steadfast commitment extends to a wealth of outstanding healthcare resources within Austin. Notably, four area hospitals have recently been named to a list of the top 100 hospitals in the U.S. Furthermore, Austin serves as a hub for cutting-edge healthcare technology companies on a global scale. The leaders in these companies, featured in this year’s list, have consistently exhibited exceptional leadership acumen. They adeptly strike a balance between achieving remarkable business success and maintaining a profound commitment to enhancing patient outcomes.

Decoding Cell Therapy Variants with Dr Andy Bader

Posted on by Staff

From Drug Target Review
The field of cell therapy has emerged as a beacon of hope, promising transformative treatments for various diseases. Diving into the intricacies of this domain, this exclusive interview explores the distinctions between two key approaches – autologous and allogeneic cell therapies. We look at the nuances of cell sourcing, preclinical challenges, and clinical possibilities, guided by the expertise of Dr Andreas Bader, a distinguished figure in the industry with a profound track record in oncology drug discovery and strategic leadership.