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.
AUSTIN, Texas and HAMILTON, ON and SOUTH SAN FRANCISCO, Calif., July 20, 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 the strengthening of its leadership team with the appointments of Mr. Robert Williamson as President, Chief Operating Officer and member of the Board of Directors, Mr. Jeffrey Erickson as VP of Business Development, and Mr. Chris Murray as VP of Human Resources.
“The appointment of Robert as our President and Director, Chris as our VP of Human Resources, and the addition of Jeffrey to the team will be instrumental in our efforts to expand our team of experts and advance our T cell Antigen Coupler (TAC) technology and lead assets, including our novel autologous cell therapy TAC100-HER2, to late-stage clinical development,” said Paul Lammers, M.D., M.Sc., Chief Executive Officer of Triumvira. “We couldn’t be more excited to bring them on board.”
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.
AUSTIN, Texas and HAMILTON, ON and SOUTH SAN FRANCISCO, Calif., June 28, 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 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 European Society for Medical Oncology (ESMO) World Congress on Gastrointestinal Cancer taking place in Barcelona, Spain, June 28 – July 1, 2023. The upcoming presentation will feature the latest clinical findings obtained from the ongoing Phase I/II trial of TAC01-HER2 (NCT04727151) among patients with relapsed or refractory solid tumors.
“We are honored to share our latest advancements in precision cell therapy at ESMO World Congress on Gastrointestinal Cancer. Our innovative and well-differentiated TAC01-HER2 cell therapy holds great promise in the treatment of HER2-positive solid tumors,” said Deyaa Adib, M.D., Chief Medical Officer of Triumvira Immunologics. “This phase 1 data presentation represents a significant step forward in our mission to transform cancer care through the natural potential of T cells. We look forward to contributing to the scientific dialogue and working towards a future where targeted T-cell therapeutics redefine the landscape of cell therapies in solid tumors, specifically in late-stage gastric and esophageal cancers which have been an area of significant unmet need for a long time.”
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.
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.
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.
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.”
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.