Roche and Manifold Bio Forge $2.055B Partnership to Develop Next-Generation Brain-Targeted Therapeutics

November 3,Boston, Manifold Bio, a platform therapeutics company pioneering AI-guided drug discovery and direct in vivo measurement, announced a strategic research collaboration and licensing agreement with Roche. The partnership will apply Manifold's proprietary tissue-targeting delivery portfolio and mDesign AI-driven in vivo discovery engine to create...Build Multiple Next-GenerationBBB Shuttles (Blood-Brain Barrier Delivery)，Used to treat nervous system and neurodegenerative diseases. (Founded by Professor George Church! Completed $40 million in financing, with Tencent following up.）

Manifold Bio CEO Dr. Gleb Kuznetsov said:"Manifold's mission is to unlock the full potential of AI-guided drug design by significantly increasing experimental throughput in living systems, overcoming translational barriers that hinder the development of critical new drugs. For decades, engineering molecules to safely cross the blood-brain barrier has been a major challenge, and this is where Manifold’s direct in vivo approach offers a decisive advantage. We look forward to collaborating with Roche, already a leader in technologies enabling drugs to cross the blood-brain barrier, to apply our methods and novel shuttle technologies to expand the breadth of brain drug delivery."

Unlike traditional methods that rely heavily on in vitro testing, Manifold's mDesign platform can be used to directly measure thousands to millions of biological variants in vivo, providing physiologically relevant data at an unprecedented scale. This allows for the rapid translation of biologics to patients, spanning antibodies, oligonucleotides, and other forms. The company is leveraging its platform to pursue a wide range of opportunities in tissue-targeted drugs, including delivering drugs to the brain using antibody-based BBB delivery — the focus of the collaboration.

Pierce Ogden, Ph.D., Chief Technology Officer of Manifold Bio, stated:"The idea behind our founding of Manifold was that leveraging large-scale in vivo data generation to power AI models would create a generative drug design engine that learns directly from living systems. Today, we have built the world’s first AI system for designing tissue-targeted biologics. With this data, we are already constructing the world’s first virtual model of a living organism. Our collaboration with Roche confirms our vision that the future of biomedicine lies in generative design driven by data directly informed by the biology of life."

The first generation of BBB delivery enhanced the efficacy of certain therapeutic payloads. Manifold's proprietary platform systematically measures thousands of potential blood-brain barrier deliveries, these brain-penetrating deliveriesDirectly deliver drugs to the brain in vivo through multiple "portals" (receptors). The resulting BBBBrain DeliveryFused with antibodies or conjugated with siRNA, ASO, or other therapeutic molecules to facilitate crossing the BBB, expanding the breadth, efficacy, and safety of the candidate products that can be developed.

Boris Zaïtra, Head of Business Development at Roche, said:"Roche has been working in the BBB brain delivery field for over 15 years and has demonstrated BBBBlood-brain deliveryA significant impact on improving antibody pharmacology. We are delighted to collaborate with Manifold to identify the next generation of highly specific BBB.Blood-brain delivery, applicable to various treatment methods to address some of the most critical neurological and neurodegenerative diseases."

According to the agreement, Manifold will lead research and discovery activities to identify and develop novel BBBs specifically tailored for selecting Roche's therapeutic payloads.Blood-brain deliveryThen, Roche will lead preclinical, clinical, and commercialization efforts. Roche will pay Manifold Bio $55 million upfront. Additionally, Manifold is eligible for significant research, discovery, and preclinical milestones, as well as clinical and sales milestones totaling over $2 billion, along with tiered royalties. Manifold also retains the right to co-fund the development of one project in exchange for higher royalties, as well as to leverage its BBBBrain DeliveryRights to therapeutic payloads applied outside of Roche-licensed targets.

Manifold Bio Executive Chairman Steven Holtzman stated:"Manifold is delighted to have the opportunity to collaborate with Roche's talented team of research and translational neuroscientists. This alliance provides Manifold with a foundational partnership that includes key structural elements, enabling the company to evolve into an independent biopharmaceutical entity, thereby creating significant value for patients, caregivers, employees, and shareholders."