Kimera® Labs Receives FDA Phase I/IIa IND Approval For Its MSC Exosomes Human Study
MIRAMAR, Fla., May 16, 2023 /PRNewswire/ — Kimera® Labs Inc., the first and leading worldwide MSC exosome research lab and producer, is pleased to announce the FDA IND (Investigational New Drug) approval of its exosomes in a Phase I/IIa clinical trial. The trial will assess the safety and efficacy of a single intravenous dose of an isolated, proprietary placental cell line derived, mesenchymal stem extracellular vesicles for the treatment of COVID-19 symptoms in adults with mild to moderate illness.
“We are excited to be one of the first companies to treat this much-needed medical condition afflicting so many people worldwide,” stated Duncan Ross, Ph.D., Founder, and CEO of Kimera Labs. “This IND will provide additional opportunities for us to target and to expand many other prevalent inflammatory-based and regenerative clinical conditions requiring our unmatched technology and capabilities.”
Kimera Labs will recruit COVID-19 patients for the IV administration of its exosome products commencing in June. This Phase I/IIa study will thoroughly investigate the safety and clinical efficacy of its advanced exosome products and technology. The Company anticipates completing its Phase I/IIa trial in a matter of months, and then to seek approval to commence the final Phase 3 study. Kimera’s exosomes are produced at its 28,000 square foot state-of-the-art FDA GMP-inspected manufacturing facilities in Miramar, Florida. Kimera Labs has established a clinical and research team to prioritize future IND clinical FDA submissions to leverage the regenerative and anti-inflammatory properties of its exosomes.
For those who may be interested, the FDA has revoked the Johnson & Johnson (Janssen) Adenovirus-based emergency use authorization (EUA) on May 7, 2023.
The FDA is also supporting later versions of mRNA vaccines but revoked the EUA for the original Pfizer and Moderna ones.