Exogenus Therapeutics Partners with Lonza on Manufacture of Exosome-Based Candidate

Communication between the manufacturing plant and retail stores. | Image Credit: © Cagkan - © Cagkan - stock.adobe.com

Exogenus Therapeutics, a biotech company based in Portugal, announced on March 11, 2025 that it has contracted the contract development and manufacturing organization, Lonza, to develop a good manufacturing practice (GMP)-compliant process for Exogenus’ exosome-based lead candidate, Exo-101. Lonza will use its expertise in exosome development and analytical services at its Sienna, Italy site to define a process to produce Exo-101 for clinical supply.

Exo-101 is derived from immunologically privileged cells from umbilical cord blood. According to Exogenus, Exo-101 has been shown to have regenerative, anti‑inflammatory, and immunomodulatory properties in multiple preclinical models. It has a multifactorial mode-of-action, mediated by a mix of small RNAs, proteins, and anti-inflammatory lipids and provides treatment options primarily for tissue regeneration and inflammatory diseases. The company expects the candidate to reach patients in 2027 (1).

“We are committed to developing innovative, safe and effective therapies in areas of high unmet medical needs, and to establishing new uses for biological waste materials,” Joana Correia, Co-Founder and CEO, Exogenus Therapeutics, said in the press release (1). “This collaboration with Lonza will be essential to achieve a robust, GMP-compliant process for Exo-101 manufacturing, as we progress towards clinical studies. We are excited to partner with a like-minded team with shared goals for the future of exosome-based technologies.”

“At Lonza, we continue to pioneer this emerging and promising field of exosomes, leading innovation to provide development and manufacturing services for our partners. This collaboration highlights our market-leading expertise in supporting exosomes and other extracellular vesicle-based products,” Davide Zocco, Head of Exosomes Development, Lonza, said in the release. “We look forward to collaborating with Exogenus Therapeutics to advance its lead candidate towards the clinic.”

In January 2025, Lonza also announced a partnership with the Swedish company, Iconovo, to develop spray-dried formulations of an intranasal biologic that would be administered through Iconovo’s intranasal device, ICOone Nasal (2,3).

“Our team at Lonza’s respiratory center of excellence in Bend [Oregon] is pleased to work with Iconovo on its innovative applications, combining Lonza’s particle engineering expertise with Iconovo’s state-of-the-art devices. Delivering non-invasive and accessible therapies to patients in need is a focus area for both companies,” Kim Shepard, director of Advanced Drug Delivery, Lonza, said at the time of the press release (3).

“This collaboration, leveraging Iconovo’s innovative intranasal delivery technology alongside our expertise in spray-dried formulations, underscores our commitment to advancing patient care by developing innovative products. We believe that combining our strengths can lead to the development of patient-friendly products and a long-lasting, successful collaboration,” said Jan Vertommen, vice-president, head of Commercial Development, Small Molecules, Lonza, in the release (3).

“Lonza is a world leader in bioavailability enhancement and renowned for its spray-drying capabilities of biologics. Combined with Iconovo’s unique nasal inhaler, we expect the result to be an unprecedented patient-friendly product, and we hope that this cooperation will lead to a fruitful, long-term collaboration that goes beyond this specific project,” said Johan Wäborg, CEO, Iconovo, in the press release (3).

Pharmaceutical Technology® spoke with Christian Morello, vice president and head of the Bioconjugates Business Unit at Lonza, in a two-part interview about Lonza’s work in developing modern antibody drug conjugates. Watch the part one of the interview here and part two here.

References

1. Exogenus Therapeutics. Exogenus Therapeutics Chooses Lonza to Develop a GMP-Compliant Process to Manufacture Exo-101, its Lead Exosome-Based Candidate. Press Release. March 11, 2025.
2. Mirasol, F. Lonza and Iconovo Team Up on Intranasal Biologic Candidate. PharmTech.com. Jan. 15, 2025. https://www.pharmtech.com/view/lonza-iconovo-team-up-intranasal-biologic-candidate
3. Lonza. Iconovo and Lonza to Collaborate on the Formulation Development of an Intranasal Biologic. Press Release. Jan. 13, 2025.