Roche has entered a strategic collaboration with Manifold Bio, investing $55 million upfront to advance new approaches for delivering drugs across the blood-brain barrier (BBB)—a long-standing challenge in neurological drug development. The partnership aims to leverage Manifold’s mDesign in vivo discovery engine and tissue-targeting shuttle portfolio to create next-generation BBB shuttles for the treatment of neurological and neurodegenerative diseases.
Under the agreement, Manifold Bio will lead the research and discovery phase, identifying and developing BBB shuttles capable of transporting Roche’s therapeutic molecules to the brain. Roche will then take over preclinical and subsequent development activities, ensuring a streamlined path from discovery to clinical application.
Beyond the initial $55 million payment, Manifold could receive up to $2 billion in milestone payments tied to development and commercialization success, as well as tiered royalties on potential future sales. The nonexclusive deal also allows Manifold to co-fund one program in return for enhanced royalties, offering the biotech an opportunity for deeper participation in the collaboration.
Originating from the Harvard laboratory of geneticist George Church, Ph.D., Manifold Bio has built its foundation on cutting-edge synthetic biology and data-driven experimentation. Its mDesign platform can systematically evaluate thousands of potential BBB shuttles directly in vivo, identifying those capable of transporting drugs through multiple receptor-mediated “portals” in the brain. Once optimized, these shuttles can be fused to antibodies or conjugated to therapeutic molecules such as siRNAs or antisense oligonucleotides, enabling precise delivery of biologics and genetic medicines to the central nervous system.
Manifold’s platform integrates AI-guided molecular design with high-throughput in vivo testing, accelerating the discovery of drug candidates that can safely and efficiently cross the BBB—a barrier that has historically limited the development of treatments for brain-related disorders. The company’s approach aims to improve translational predictability and overcome one of neuroscience’s most persistent scientific hurdles.
Roche has been working in the BBB shuttle space since 2008, with significant progress including trontinemab, a bispecific 2+1 amyloid-beta antibody that entered phase 3 development earlier this year. The partnership with Manifold Bio reinforces Roche’s long-term commitment to expanding its CNS (central nervous system) pipeline and developing technologies that enhance the delivery of therapies to the brain.
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