Lonza to Support Exogenus in GMP Manufacturing of Exo-101

• Exogenus Therapeutics and Lonza have entered a collaboration to develop Exo-101, an exosome-based therapy targeting tissue regeneration and inflammatory diseases.

• Lonza will use its Siena, Italy site to establish a GMP-compliant manufacturing process for Exo-101, supporting clinical supply.

Exogenus Therapeutics, a Portuguese biotech company, has partnered with Lonza to advance the development of Exo-101, its exosome-based lead candidate. The agreement focuses on establishing a Good Manufacturing Practice (GMP)-compliant process for clinical supply, leveraging Lonza’s expertise in exosome development and analytical services.

Exo-101, derived from immunologically privileged cells from umbilical cord blood, has demonstrated regenerative, anti-inflammatory, and immunomodulatory properties in preclinical models. The therapy is designed for patients with limited treatment options in tissue regeneration and inflammatory diseases and is expected to reach the market in 2027.

As part of the collaboration, Lonza’s team at its Siena, Italy site will define a robust GMP manufacturing process based on Exogenus Therapeutics’ foundational work. The feasibility effort aims to support the transition of Exo-101 into clinical trials.

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

Davide Zocco, Head of Exosomes Development at Lonza, noted that the company continues to be at the forefront of exosome development, driving innovation in providing manufacturing and development services. He emphasized that this collaboration demonstrates Lonza’s expertise in supporting exosome and extracellular vesicle-based products and looks forward to working with Exogenus Therapeutics to move Exo-101 closer to clinical application.