Contract Pharma Staff01.12.21
Capricor Therapeutics, a biotechnology company focused on the development of the first-in-class cell and exosome-based therapeutics, and Lonza, entered an agreement for the development of CAP-1002, its leading clinical asset using allogeneic cardiosphere-derived cells (CDC) technology for the treatment of Duchenne Muscular Dystrophy (DMD) and complications arising from COVID-19.
CAP-1002 completed the Phase 2 clinical trial and has been granted orphan drug designation by the FDA for the treatment of DMD. CAP-1002 also received FDA acceptance of its IND application for a Phase 2 trial of CAP-1002 in patients with COVID-19 in August 2020.
The agreement aims to expand Capricor’s manufacturing capacity for potential late-stage clinical trials and commercialization. Operations will begin with a tech-transfer to Lonza’s Houston, TX center of excellence, where Lonza will perform process development activities for late-clinical and commercial-scale GMP manufacturing of CAP-1002.
“As we continue to expand our manufacturing efforts for CAP-1002, our lead cell therapy product candidate, this collaboration with Lonza provides us with a partner which has world-class expertise in technology transfer and an established track record of commercializing biologics,” said Linda Marbán, Chief Executive Officer of Capricor. “We are excited because this is an important step in our ability to potentially bring CAP-1002 closer to commercialization and allows us to bring this important therapy to patients with Duchenne muscular dystrophy as quickly as possible, if approved.”
“Capricor’s lead candidate CAP-1002 is demonstrating efficacy in late-stage clinical studies to significantly benefit patients,” said Alberto Santagostino, SVP, Head of Cell and Gene Technologies, Lonza. “We will leverage our process development expertise and industrial manufacturing capabilities to enable Capricor to scale this therapy and make it available to patients globally, once approved for commercialization.”
CAP-1002 completed the Phase 2 clinical trial and has been granted orphan drug designation by the FDA for the treatment of DMD. CAP-1002 also received FDA acceptance of its IND application for a Phase 2 trial of CAP-1002 in patients with COVID-19 in August 2020.
The agreement aims to expand Capricor’s manufacturing capacity for potential late-stage clinical trials and commercialization. Operations will begin with a tech-transfer to Lonza’s Houston, TX center of excellence, where Lonza will perform process development activities for late-clinical and commercial-scale GMP manufacturing of CAP-1002.
“As we continue to expand our manufacturing efforts for CAP-1002, our lead cell therapy product candidate, this collaboration with Lonza provides us with a partner which has world-class expertise in technology transfer and an established track record of commercializing biologics,” said Linda Marbán, Chief Executive Officer of Capricor. “We are excited because this is an important step in our ability to potentially bring CAP-1002 closer to commercialization and allows us to bring this important therapy to patients with Duchenne muscular dystrophy as quickly as possible, if approved.”
“Capricor’s lead candidate CAP-1002 is demonstrating efficacy in late-stage clinical studies to significantly benefit patients,” said Alberto Santagostino, SVP, Head of Cell and Gene Technologies, Lonza. “We will leverage our process development expertise and industrial manufacturing capabilities to enable Capricor to scale this therapy and make it available to patients globally, once approved for commercialization.”
