Exogenus Therapeutics, a Portuguese biotech company, and Lonza, a global development and manufacturing company, have entered a partnership to develop Exo-101, Exogenus’ exosome-based lead candidate.

Under the agreement, Lonza will leverage its expertise in exosome development and analytical services from its Siena (IT) site to define a GMP-compliant process for Exo-101 production. Production will be based on the foundational work from Exogenus Therapeutics. This feasibility effort aims to define the path toward Exo-101 manufacturing for clinical supply.

Exo-101, derived from immunologically privileged cells from umbilical cord blood, has been shown to have regenerative, anti‑inflammatory, and immunomodulatory properties in multiple preclinical models and is expected to reach patients in 2027. Its multifactorial mode of action, mediated by small RNAs, proteins, and anti-inflammatory lipids, provides the foundation for the drug’s therapeutic potential and positive safety profile. Exo-101 targets patients lacking effective treatment options, primarily in the areas of tissue regeneration and inflammatory diseases.

Joana Correia, Co-Founder and CEO, Exogenus Therapeutics, commented, “This collaboration with Lonza will be essential to achieve a robust, GMP-compliant process for Exo-101 manufacturing, as we progress towards clinical studies.”