Manifold Bio is a platform therapeutics company that pioneers AI-guided drug discovery coupled with direct-to-vivo measurement. On the 3rd of November, the company announced a strategic research collaboration and licence agreement with Roche.The partnership will make the most of Manifold’s AI guided direct-to-vivo platform for Roche to create multiple novel brain-targeted therapeutic products.

Key Takeaways

  • Manifold Bio and Roche have entered a strategic collaboration worth up to $2 billion to develop brain-targeted therapeutics.
  • The partnership leverages Manifold’s AI-guided direct-to-vivo platform to overcome the long-standing challenge of crossing the blood-brain barrier (BBB).
  • Manifold will lead discovery efforts, while Roche will handle preclinical, clinical, and commercialisation stages, starting with a $55 million upfront payment.

Purpose and Scope of the Partnership

The overarching aim is to apply Manifold’s proprietary tissue-targeting shuttle portfolio and its mDesign AI-driven in vivo discovery engine. The goal is to create multiple next-generation BBB shuttles for treating complex neurological and neurodegenerative diseases. Both of these areas have high unmet needs.

Why This Approach is Different

Traditional approaches tend to heavily depend on in vitro assays. In contrast, Manifold’s mDesign platform measures thousands to millions of biologic variants directly in vivo. This provides relevant data at an impressive scale and can facilitate the rapid translation of biologics to patients.

Gleb Kuznetsov, Co-Founder and Chief Executive Officer of Manifold Bio, stated: “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.”

He continued, “We look forward to working with Roche, already a world-leader in technology to enable medicines to cross the BBB, to bring our approach and novel shuttle technologies to expand the breadth of brain-shuttled medicines.”

Financial and Development Terms

Under the agreement, Manifold will lead research and discovery activities to identify and develop novel BBB shuttles tailored to select Roche therapeutic payloads. Roche will then lead preclinical, clinical, and commercialisation efforts. Roche will pay Manifold an upfront fee of $55 million (USD).

Furthermore, Manifold is eligible to receive significant research, discovery, and preclinical milestones, alongside clinical and sales milestones, totalling over $2 billion. Manifold also retains the right to co-fund the development of one programme in exchange for enhanced royalties and can apply its BBB shuttles to therapeutic payloads outside of Roche’s licensed targets.