Author: Staff

Triumvira shares upcoming plans for accelerated approval with cell therapies

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US-based Triumvira Immunologics will aim for accelerated approval for its TAC01-HER2 by the US Food and Drug Administration (FDA) in gastric and oesophageal cancers, chief medical officer Dr. Deyaa Adib told Clinical Trials Arena.

Adib noted: “It’s an area of significant unmet medical needs, where the standard of care has not changed over the last 40 years.”

TAC01-HER2 is a novel cell therapy that consists of genetically engineered autologous T cells expressing T-cell antigen coupler (TAC), which recognizes human epidermal growth factor receptor 2 (HER2).

Triumvira Immunologics expects to complete the Phase II component of their Phase I/II trial in HER2-positive solid tumors in 2025. The Phase II portion will be a registration-enabling study and it is based on the three-stage Simon hypothesis. The second part of the trial is expected to enroll 72 patients who have passed between two to four prior lines.

DDW Events: AACR 2023 Episode 2 with Andreas Bader, Triumvira Immunologics

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At the American Association of Cancer Research’s Annual Meeting in Orlando, Florida, DDW’s Megan Thomas met with industry experts to learn more about their research and careers in the field of cancer research.

In this latest episode, Thomas speaks with Andreas Bader, Chief Scientific Officer at Triumvira Immunologics.

Dr Schlechter on TAC01-HER2 Therapy in HER2+ Solid Tumors

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Benjamin L. Schlechter, MD, senior physician, Dana-Farber Cancer Institute, instructor, medicine, Harvard Medical School, discusses the future implications of TAC01-HER2 therapy in patients with HER2-positive solid tumors.

The ongoing, phase 1/2 TACTIC-2 trial (NCT04727151) is evaluating the efficacy and safety of autologous TAC01-HER2 T-cell therapy in patients with HER2-positive breast, colorectal, gall bladder, gastroesophageal junction (GEJ), gastric, esophageal, lung, and ovarian cancers.

Interim findings from this trial, presented at the 2023 ASCO Annual Meeting, showed 2 partial responses to the therapy, 1 in a patient with refractory GEJ cancer, and 1 in a patient with refractory gastric cancer. In the patients with gastric, GEJ, or esophageal cancer, the disease control rate (DCR) was 83% and the overall response rate was 33%. In heavily pretreated patients, the DCR was 67%. One dose-limiting toxicity (DLT), grade 3 pneumonitis, was observed, and 1 patient had grade 3 cytokine release syndrome. No incidence of immune effector cell–associated neurotoxicity syndrome has been reported.

Triumvira Immunologics Highlights Positive Phase 1 Clinical Data on TAC01-HER2 in Solid Tumors at ASCO 2023 Annual Meeting

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AUSTIN, Texas and HAMILTON, ON and SOUTH SAN FRANCISCO, Calif., May 31, 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 positive data from its Phase I/II trial investigating the safety and efficacy of autologous TAC01-HER2 in refractory solid tumors (TACTIC-2/NCT04727151), will be presented at the 2023 American Society Of Clinical Oncology (ASCO) Annual Meeting, held June 2-6 in Chicago. Benjamin L. Schlechter, MD, from Harvard Medical School, and a Senior Physician in Gastrointestinal Oncology at Dana-Farber Cancer Institute, will highlight updated clinical data demonstrating the potential of TAC01-HER2 as a targeted therapy for patients who are refractory to existing HER2-targeted therapies.

“We are encouraged by the promising results from the TACTIC-2 trial, which demonstrate the safety and compelling clinical activity of autologous TAC01-HER2 in refractory solid tumors,” said Deyaa Adib, M.D., Chief Medical Officer of Triumvira Immunologics. “These findings suggest that TAC technology has the potential to transform the treatment landscape for patients with HER2-positive gastric and esophageal cancers, offering a novel approach that harnesses the natural biology of T cells. We look forward to further exploring the therapeutic benefits of TAC01-HER2 in the phase 2 component of the trial and advancing its development towards improving patient outcomes in this population that have been deprived of significant therapeutic progress over the last 40 years.”

A Different Approach, A New Cancer Drug… Dr. Paul Lammers, CEO Triumvira Immunologics

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Cancer treatments that work with the immune system are making great strides, with Keytruda from Merck being perhaps the best known. Still, there is much work to be done – both in developing unprecedented new treatments, as well as treatments that might combine with our existing treatments to make them even more effective. Triumvera (try-um-VEERA) Immunologics is working on both. Dr. Paul Lammers is its CEO.

Triumvira Immunologics to Present Clinical Data from Phase I/II Trial TACTIC-2 Investigating TAC01-HER2 at the 2023 ASCO Annual Meeting

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AUSTIN, Texas and HAMILTON, ON and SOUTH SAN FRANCISCO, Calif., May 16, 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 Company will be presenting clinical data on its lead asset TAC01-HER2 for the treatment of human epidermal growth factor receptor 2 (HER2) positive solid tumors at the 2023 American Society Of Clinical Oncology (ASCO) Annual Meeting, taking place in Chicago, IL, June 2-6. The presentation by Benjamin L. Schlechter, MD, from Harvard Medical School and a Senior Physician in Gastrointestinal Oncology at the Dana-Farber Cancer Institute, will highlight updated clinical data from the ongoing Phase I/II trial of TAC01-HER2 (NCT04727151) in patients with relapsed or refractory solid tumors.

“We are excited to present the latest clinical data from our Phase I/II trial of TAC01-HER2 in refractory solid tumors at the upcoming ASCO meeting as a poster and a poster discussion. The availability of updated clinical data will offer remarkable insights into the potential of TAC01-HER2 as a targeted therapy for patients who are refractory to existing HER2 targeted therapies,” said Deyaa Adib, M.D., Chief Medical Officer of Triumvira Immunologics. “We are committed to delivering innovative solutions for cancer patients and addressing critical unmet medical needs and look forward to sharing the updated findings with the oncology community at this prestigious scientific meeting.”

Joy and Boldness in Drug Development – with Paul Lammers

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Join us in this episode as we talk with Paul Lammers, CEO of Triumvira Immunologics, a clinical-stage biopharmaceutical company focusing on developing T cell therapies for cancer treatment. Born in the Netherlands and now an American citizen, Lammers’ early life shaped his views on being bold and making connections with people a priority. He shares his insights on crucial but often neglected topics in life science leadership, while also revealing his joy as a father to three grown daughters and a grandfather.

We discuss the importance of transparent and open communication between leaders and employees, especially during times of change or uncertainty. Lammers also shares his thoughts on the challenges of balancing innovation and risk with regulatory and financial constraints. Additionally, we delve into the significance of investing in talent development and creating opportunities for employees to learn and grow, both for their own advancement and the success of the organization. Tune in to learn from Paul Lammers’ experiences and gain insights into effective leadership strategies in the biotech industry.

Triumvira Immunologics Presents Promising Data on TAC T Cells for the Treatment of HER2-overexpressing Solid Tumors at the 2023 AACR Annual Meeting

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AUSTIN, Texas and HAMILTON, ON and SOUTH SAN FRANCISCO, Calif., April 18, 2023 /PRNewswire/ — Triumvira Immunologics, a clinical-stage company developing novel, targeted autologous and allogeneic T cell therapeutics, today announced the details of the Company’s presentation at the 2023 AACR Annual Meeting on its lead asset, TAC01-HER2, for the treatment of human epidermal growth factor receptor 2 (HER2) positive solid tumors. The presentations will include updated clinical data from the ongoing TACTIC-2 trial of TAC01-HER2 (NCT04727151) in patients with solid tumors and preclinical data on an allogeneic HER2-TAC T cell product.

Presentation details:

Title: A Phase I/II Trial Investigating Safety and Efficacy of Autologous TAC01-HER2 in Relapsed or Refractory Solid Tumors

Authors: Ecaterina E. Dumbrava, MD, Daniel Olson, MD, Samuel Saibil, MD, Brooke Pieke, Mridula A. George, MD, Riemke Bouvier, Kelly Gruber, Kara Moss, Nathan Ternus, Maria Apostolopoulou, Deyaa Adib, MD, and Benjamin L. Schlechter, MD.

A phase I/II trial investigating safety and efficacy of autologous TAC01-HER2 in relapsed or refractory solid tumors

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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, 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 recognize 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) whom have progressed on prior anti-cancer therapies.

• We present updated preliminary data from Cohorts 1-4 (19 participants) that highlights safety and efficacy data; the study further elucidates potential therapeutic impact to patients with HER2 overexpressed solid tumors.

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Patient-derived TAC01-HER2 TAC T cells produced in Cocoon® Platform is highly functional in models of solid tumors

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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 to elicit a safe and durable anti-tumor response. TAC01-HER2, a 􀈈rst-inclass TAC T product targeting HER2 (ERBB2), has entered a Phase I/II clinical trial in patients with HER2-positive solid tumors. Here, we characterized the TAC T cell phenotypes and anti-tumor activity of TAC01-HER2 manufactured using leukocytes from Phase I/II patients in nonclinical in vitro and in vivo assays.

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