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Under the terms of the agreement, operations will be initiated at Lonza’s Houston, TX Center of Excellence where Lonza will handle process development activities for late-clinical and commercial-scale GMP manufacturing of the cell therapy.
Lonza and Capricor Therapeutics, a US-based clinical-stage biotechnology company, announced on Jan. 12, 2020 that they are entering into an agreement for the development of CAP-1002, Capricor's clinical cell therapy that uses allogeneic cardiosphere-derived cells technology for the treatment of Duchenne Muscular Dystrophy. The therapy is also in a clinical trial to treat complications arising from COVID-19.
Under the terms of the agreement, operations will be initiated at Lonza’s Houston, TX Center of Excellence where Lonza will handle process development activities for late-clinical and commercial-scale GMP manufacturing of the cell therapy, Lonza said in a company press release. Additionally, the collaboration will work to expand Capricor’s manufacturing capacity for possible late-stage clinical trials and commercialization.
“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, CEO, Capricor Therapeutics, in the press release. “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,” added Alberto Santagostino, senior vice president, head of Cell and Gene Technologies, Lonza, in the press release. “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.”
Capricor also received FDA acceptance of an investigational new drug application for a phase II clinical trial of CAP-1002 in patients with COVID-19, in August 2020.