The BioPharm Brief: Insulin Supply Security, a Bispecific Head-to-Head, and Long-Acting HIV Antibodies

Welcome to The BioPharm Brief, your daily snapshot of developments shaping the biopharmaceutical industry. Today, we cover a major investment in European insulin manufacturing, a new registrational trial for a PD-1/VEGF bispecific, and early data on a long-acting antibody approach to HIV.

First, Sanofi has broken ground on a new insulin manufacturing facility at its BioCampus in Frankfurt, Germany. The highly automated plant will produce insulin API, with full production planned for 2032 once it is licensed. The project is backed by €400 million (about $449 million) in German state aid approved by the European Commission. In return, Sanofi must produce at least 1.1 tonnes of insulin a year at the site through 2042, keep a 1-tonne API stockpile and prioritize European markets during shortages.

Next, Akeso’s partner Summit Therapeutics has teamed with the ECOG-ACRIN Cancer Research Group on a registration-enabling phase 2/3 trial of ivonescimab in advanced biliary tract cancer. The study, EA2251, will compare the PD-1/VEGF bispecific plus chemotherapy against pembrolizumab or durvalumab plus chemotherapy as first-line treatment, putting it head to head with current immunotherapy standards. US site activations are expected this quarter. Detailed results from the China-based HARMONi-GI1 trial, which met its overall survival end point, are set for presentation at ESMO on October 25.

And TaiMed Biologics reported that its second-generation anti-CD4 antibody, TMB-365, reduced HIV viral load without resistance in a 25-person phase 1 study. Because it binds a receptor on the patient’s own T cells rather than the virus, TMB-365 works differently from virus-targeting antibodies. Receptor occupancy data support testing dosing every 8 to 12 weeks. TaiMed is pairing TMB-365 with the broadly neutralizing antibody TMB-380 as a potential antibody-only maintenance regimen, with interim phase 2b results expected by the end of 2026.

That’s today’s BioPharm Brief. For analysis and expert insights, please visit BioPharmInternational.com.

Key takeaways

• Insulin supply resilience: Public funding is now tied directly to production and stockpiling obligations for Sanofi’s new Frankfurt insulin plant.
• Bispecific vs. standard of care: EA2251 will test ivonescimab against immunotherapy-based regimens, not chemotherapy alone, in first-line biliary tract cancer.
• Longer dosing intervals: TMB-365’s host-directed mechanism and receptor occupancy data support its development as a backbone for long-acting HIV regimens.