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

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

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.

The Top 25 Healthcare Technology Leaders of Austin for 2023

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

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.

Conquering New Frontiers in Cell Therapy, Paul Lammers, CEO, Triumvira Immunologics

From BioTech 2050 Podcast
Paul Lammers, M.D., is the CEO of Triumvira Immunologics, a clinical-stage immuno-oncology company developing unique, targeted autologous and allogeneic T cell therapeutics that co-opt the natural biology of T cells to treat a broad range of patients with cancer. A Dutch-trained biologist and physician, Paul talks about starting his career in pharma and some of the commonalities between operating in pharma and biotech. He talks about being a CEO and how his approach to running a company has evolved over the years. He discusses the uncertainty in the market and how that’s informing how the company is approaching development activities. He dives into the fundamental challenges and opportunities within cell therapy and the work Triumvira is doing to treat cancer.

Advancements in Cell Therapy for Solid Tumors

In the first of 3 videos, Paul Lammers, MD, MSc, chief executive officer of Triumvira, discusses the company’s unique T antigen coupler (TAC) T-cell technology. Daniel Olson, MD, Assistant Professor of Medicine, the University of Chicago Medicine, presented an abstract about the ongoing phase 1/2 study evaluating the safety and efficacy of TAC01 in HER2-expressing relapsed or refractory tumors (NCT04727151) at the Society for Immunotherapy of Cancer 38th Annual Meeting November 1-5, 2023

Here, Lammers describes the TAC mechanisms and what sets it apart from chimeric antigen receptor (CAR) T-cell therapy.
Related: About the Phase 1/2 Trial of TAC-01 in HER2-Expressing Solid Tumors

Biotech M&A Rebound Bodes Well for Venture Investors

Regulatory scrutiny of acquisitions could slow momentum

Biotechnology mergers and acquisitions are rebounding, a promising development for venture capitalists at a time when few startups are going public.

Top drugmakers could soon forfeit billions in revenue as medications lose patent protection. Meanwhile, valuations of smaller biotech companies have retreated from pandemic-era highs, leading to more acquisitions.

“Large pharma still has a lot of cash, and they have a lot of drugs that are going to go generic over the next five to 10 years,” said Mike Perrone, a biotech specialist with financial-services firm Robert W. Baird.

Claudin-18.2 attracts the cancer crowd

Astellas’s claudin-18.2-targeted antibody zolbetuximab provides a benefit in hard-to-treat metastatic gastric cancer, and leads a multi-modality herd of contenders.

Gastric cancer is a beast. Despite being the fourth most fatal cancer worldwide — killing nearly 770,000 people per year — drug developers have made little headway against it in decades. For most patients with metastatic disease, the first-line treatment is chemotherapy that offers an average overall survival of about 1 year. With Astellas’s recent filing of its claudin-18.2-targeted antibody zolbetuximab for regulatory approval in the USA, the EU and Japan, a new therapeutic option for a large subset of these patients is within reach.

Triumvira shares upcoming plans for accelerated approval with cell therapies

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

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.