Manifold Bio, a cutting-edge therapeutics company specializing in AI-guided drug discovery, has announced a strategic research collaboration and licensing agreement with Roche. This partnership will leverage Manifold's innovative tissue-targeting shuttle portfolio along with its mDesign AI-driven in vivo discovery engine to develop multiple next-generation blood-brain barrier (BBB) shuttles aimed at treating neurological and neurodegenerative diseases.

“Manifold’s mission is to unlock the full potential of AI-guided drug design with drastically increased experimental throughput in living systems to overcome the translational barrier holding back the creation of critical new medicines,” said Gleb Kuznetsov, Ph.D., Co-Founder and Chief Executive Officer of Manifold Bio. He emphasized the significance of engineering molecules that can safely cross the blood-brain barrier, stating, “Engineering molecules to safely cross the blood-brain barrier has been a grand challenge for decades, and it’s exactly the kind of problem where Manifold’s direct-to-vivo approach provides a decisive edge.”

The collaboration is set to yield $55 million upfront for Manifold, with the potential for over $2 billion in total research, preclinical, clinical development, and commercial milestones, as well as tiered royalties. Manifold retains the right to apply its BBB shuttles to non-licensed targets in its own and future partnered programs.

Pierce Ogden, Ph.D., Co-Founder and Chief Technology Officer of Manifold Bio, explained the foundation of their work: “We founded Manifold on the idea that leveraging large-scale in vivo data generation to power AI models would result in a generative drug design engine that learns directly from living systems.” He highlighted the company's progress, stating, “Today we’ve built the world’s first AI system for the design of tissue-targeted biologics.”

With a focus on BBB shuttles, Manifold’s platform systematically evaluates thousands of candidates that can facilitate the delivery of therapies to the brain through various receptors. These shuttles can then be combined with antibodies or other therapeutic agents to enhance their efficacy and safety.

“Roche has worked in the field of BBB shuttles for over 15 years and has demonstrated the significant impact BBB shuttles can have on improving antibody pharmacology,” noted Boris Zaïtra, Head of Corporate Business Development at Roche. “We are excited about our partnership with Manifold to identify the next generation of highly specific BBB shuttles, applicable across multiple therapeutic modalities, to tackle some of the most important neurological and neurodegenerative diseases.”

Under the terms of the agreement, Manifold will spearhead the research and discovery activities to develop novel BBB shuttles tailored for select Roche therapeutic payloads, while Roche will manage preclinical, clinical, and commercialization efforts. In addition to the upfront payment, Manifold stands to gain substantial research and clinical milestone payments as well as tiered royalties.

“Manifold is delighted to have the opportunity to collaborate with Roche’s team of talented research and translational neuroscientists,” said Steven Holtzman, Executive Chair of Manifold Bio. He added, “This alliance provides Manifold with a foundational partnership that contains key structural elements that will enable the Company to grow as an independent biopharmaceutical company, thereby enabling us to create significant value for patients, caregivers, employees, and shareholders.”