Alaya.bio is a biotechnology company developing an in vivo CAR-T platform designed to overcome the cost and manufacturing bottlenecks of traditional ex vivo therapies. Its approach uses a polymeric nanoparticle system that delivers genetic instructions directly to a patient’s T cells, reprogramming them in situ to recognize and destroy cancer cells, thereby eliminating the need to extract, modify, and reinfuse cells.

The platform combines a novel polymeric composition with a dedicated administration system, aiming to enable safe, efficient, and scalable manufacturing. The technology is protected by a patent-backed delivery method that differentiates it from other in vivo approaches. The first application targets immuno-oncology, developed in collaboration with Columbia University and Dr. Michel Sadelain, a recipient of the Breakthrough Prize 2024. Beyond oncology, the platform targets other diseases where immune modulation is pivotal.

Alaya.bio is led by co-founders Cécile Bauche and Renaud Vaillant, both recognized as pioneers in cellular and gene therapy, alongside Michel Sadelain. The board includes experienced industry figures such as Johannes Fruehauf, Stefan Wildt, and Loïc Vincent, providing scientific credibility and strategic guidance.

In the current landscape, CAR-T therapies face high production costs and logistical challenges, with estimates around half a million dollars per patient for ex vivo approaches. Alaya.bio’s strategy seeks to reduce cost and complexity and broaden accessibility by enabling CAR-T therapy to be administered in vivo. The company emphasizes clinical translation and regulatory pathways as central to its development.

The first-in-human trial is planned within 12 months to assess nanoparticle safety and advance toward IND-enabling milestones and readiness for a conventional Phase 1/2 program under global regulatory frameworks.