Roche and Manifold Bio Forge $2B Partnership to Advance Blood-Brain Barrier Drug Delivery

Roche, a global pharmaceutical giant, has entered into a significant partnership with Manifold Bio, a biotech startup, to develop innovative blood-brain barrier (BBB) shuttle technology. The collaboration, which could be worth up to $2 billion, aims to revolutionize the delivery of therapeutics to the brain for treating neurological and neurodegenerative diseases.

Deal Structure and Financial Terms

Roche will pay Manifold Bio an upfront fee of $55 million to access the biotech's tissue-targeting shuttle portfolio and its in vivo discovery engine, mDesign. The agreement includes potential development and sales milestones totaling $2 billion, as well as tiered royalties on any resulting marketed therapies. Notably, the deal is non-exclusive, allowing Manifold Bio the option to co-fund the development of one program in exchange for enhanced royalties.

Technology and Development Focus

The partnership will leverage Manifold Bio's mDesign platform, which systematically evaluates thousands of potential BBB shuttles in vivo. These shuttles are designed to transport medicines across the blood-brain barrier through multiple receptor-mediated pathways. Manifold Bio's approach involves fusing these shuttles with antibodies or conjugating them with therapeutic molecules such as siRNAs or antisense oligonucleotides.

Roche, which has been working on BBB shuttle technology since 2008, sees this collaboration as an opportunity to expand its capabilities in brain-targeted drug delivery. The company's existing efforts have already yielded trontinemab, a brain shuttle bispecific antibody targeting amyloid-beta, which entered phase 3 clinical trials this year.

Roles and Responsibilities

Under the terms of the agreement, Manifold Bio will lead the initial research and development activities to identify and develop new BBB shuttles compatible with Roche's therapeutic pipeline. Once suitable candidates are identified, Roche will take over preclinical development and subsequent stages.

Gleb Kuznetsov, Ph.D., CEO of Manifold Bio, emphasized the company's mission to "unlock the full potential of AI-guided drug design" and highlighted the critical nature of overcoming the blood-brain barrier in drug development. Boris Zaïtra, head of corporate business development at Roche, expressed enthusiasm for the partnership, citing the potential to develop highly specific BBB shuttles applicable across multiple therapeutic modalities.