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.

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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.

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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.

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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.

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

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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.

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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.

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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.

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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.

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Cell therapies are revolutionizing the way cancers are treated, but existing cell therapies have their limits. They have been more successful at treating hematologic tumors than solid tumors, and they can sometimes cause serious side effects, such as the destruction of antibodies or what’s known as cytokine storms in which the immune system gets over-revved and attacks healthy cells. Triumvira Immunologics is developing autologous and allogeneic T-Cell therapies that it believes can address the limitations of existing cell therapies and be used to treat both liquid and solid tumors.

We spoke to Paul Lammers, CEO of Triumvira, about the company’s platform technology, why it’s robust and versatile, and why its lead indication is for cancer where effective treatments already exist.

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For episode 25, we sit down with Dr. Paul Lammers, CEO of Triumvira Immunologics. Stay tuned to learn why having multiple programs in clinical trials can provide a safety net should one program fail and how it adds additional value for investors. First In Human is a biotech-focused podcast that interviews industry leaders and investors to learn about their journey to in-human clinical trials.

Presented by Vial, a tech-enabled CRO, hosted by Simon Burns, CEO & Co-Founder & guest host Co-Founder, Andrew Brackin.

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In this Health Professional Radio interview – Learn how Triumvira Immunologics is developing novel T-Cell therapies to treat cancer patients. Discover how their autologous and allogeneic targeted therapeutics co-opt the natural biology of T cells.

Find out more from CEO Dr. Paul Lammers.

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