The BioPharm Brief: Approval, Investment, and Antibodies

Welcome to The BioPharm Brief, your daily snapshot of developments shaping the biopharmaceutical industry.

We’ll start with a significant regulatory milestone in oncology.

China’s National Medical Products Administration has approved ivonescimab in combination with chemotherapy for first-line treatment of advanced squamous non-small cell lung cancer, based on results from the phase 3 HARMONi-6 trial. The bispecific antibody targets both PD-1 and VEGF, combining immune checkpoint inhibition and anti-angiogenic activity in a single molecule. The 532-patient study showed a 34% reduction in the risk of death compared with tislelizumab plus chemotherapy and, most notably, demonstrated superiority over an established PD-1-based regimen in a phase 3 head-to-head trial.

Next, Silence Therapeutics is raising $175 million through a public offering to support its siRNA pipeline and broader development activities. The company’s pipeline includes divesiran, its siRNA therapy targeting TMPRSS6, which recently generated positive phase 2 data in polycythemia vera. The financing gives Silence additional capital to advance that program and its broader RNAi platform.

And finally, Infinimmune has raised $75 million in a Series A financing to advance a pipeline of human-derived antibodies, including programs targeting atopic dermatitis. The company is developing antibodies derived from human immune responses, with the goal of identifying therapeutics against disease targets that may be difficult to address through conventional antibody discovery approaches.

And that’s where we’ll leave it for today.

Thanks for listening to The BioPharm Brief. For analysis and expert insights, please visit BioPharmInternational.com.

Key takeaways:

• Ivonescimab plus chemotherapy received NMPA approval for first-line squamous NSCLC after demonstrating an overall survival benefit in phase 3.
• Silence Therapeutics is raising $175 million to advance its siRNA pipeline.
• Infinimmune secured $75 million to advance human-derived antibody programs, including candidates for atopic dermatitis.