Exogenus selects Lonza to develop GMP process for lead exosome-based candidate

Exogenus Therapeutics has partnered with Lonza to develop a GMP-compliant manufacturing process for Exo-101, the company’s lead exosome-based candidate.

Exo-101, derived from umbilical cord blood, has demonstrated regenerative, anti-inflammatory, and immunomodulatory properties in preclinical studies. The therapy is being developed for patients with limited treatment options in tissue regeneration and inflammatory diseases, with an expected market entry in 2027.

Under the agreement, Lonza will utilize its Siena, Italy site to establish a scalable GMP-compliant process for Exo-101 production. The effort will build on Exogenus’ foundational work and leverage Lonza’s expertise in exosome development and analytical services. The collaboration aims to define the steps necessary to manufacture Exo-101 for clinical supply.

Exosomes are an emerging area in biopharmaceutical development, offering potential in regenerative medicine and targeted therapies. By combining Exogenus’ advancements in exosome-based therapeutics with Lonza’s manufacturing capabilities, the partnership seeks to accelerate the transition of Exo-101 from research to clinical application.

Several exosome-based therapeutic candidates are in development across various fields, including oncology, neurology, and dermatology. Companies like Aegle Therapeutics are exploring exosome therapies for rare skin disorders, while researchers are leveraging exosomes for drug delivery in neurodegenerative diseases like Alzheimer’s.