Cells for Cells (“C4C”), a clinical-stage biotech pioneering allogeneic stem cell and stem-cells-derived therapeutics for high-impact chronic diseases, announced a 6-month follow-up of the groundbreaking Clinical Data from the First-ever patient dosed with an exosome-produced therapy for osteoarthritis. The results were made public at an extracellular vesicles signature series during the ISCT annual meeting in San Francisco and the ISEV meeting in Lyon, France.
Dr. Maroun Khoury, Chief Scientific Officer of C4C, presented the results of the first trial evaluating the safety and efficacy of exosome biotherapeutics in joint disease. This study reported an unprecedented WOMAC score reduction six months after a single administration of XO-101, C4C’s flagship exosome therapy derived from mesenchymal stem cells (MSC). The exceptional milestone suggests that XO-101 may provide a significant positive effect on the treatment of osteoarthritis, which affects the quality of life of more than 32 million people in the US. The encouraging outcome of the first-in-human study supports the interest in the ongoing ExoOA-1 Phase I Study (clinicaltrials.gov identifier: NCT05060107), which will recruit ten patients.
The preclinical data gathered after 12 studies demonstrate XO-101’s cartilage regeneration capacity and increased bone mineral density in cases of clinical OA in vivo. Both therapeutic effects are now being corroborated in first patients. “Milestones like these are great boosters for pushing our clinical program forward. The lack of any observed adverse effect in this first-in-human trial reinforces the safety profile of C4C’s MSC-derived exosomes and their potential as disease-modifying agents,” said Dr. Khoury.
The XO-101 product was first in the race to the clinic and could be among the first exosome therapies approved by the FDA. Following this success, Cells for Cells decided to spin out its exosome asset into a new US-based company focusing on well-aging and longevity.
“The first-patient milestone positioned C4C ́s exosome therapy at the forefront of the field, and, in order to capitalize upon that achievement, we decided that forming a new venture was the best route for clinical and financial success. The NewCo will seek to raise US$ 18 million to finance the XO-101’s Phase IB and II studies in the US and the R&D and Phase I for XO-101+, its drug-loaded allogeneic exosome-based therapy,” remarked Maximiliano Kunze, Associate Director of Business Development at C4C.
Source – Globe Newswire