Johnson & Johnson’s Janssen Biotech entered into an exclusive license option agreement to develop Capricor Therapeutics’ cell therapy program for cardiovascular applications—including its lead product, CAP-1002, a heart-disease treatment now heading into Phase II clinical trials—in a deal that could net Capricor as much as $337.5 million.

Janssen agreed to pay Capricor $12.5 million up front, and up to $325 million if Janssen exercises option rights, plus royalties on commercial sales of CAP-1002. Under the agreement, Janssen has the right to enter into an exclusive license agreement for CAP-1002 at any time until 60 days after Capricor delivers six-month follow-up results from Phase II of its ALLSTAR clinical trial for the cell therapy.

CAP-1002 is an allogeneic cardiosphere-derived cell therapy under study in patients who have suffered a large myocardial infarction.

“This collaboration with Janssen, one of the world’s largest and most respected healthcare companies with a strong presence in cardiovascular and metabolism, is a tremendous milestone for Capricor Therapeutics and an important validation of our lead product, CAP-1002, and the underlying science,” Capricor CEO Linda Marban, Ph.D., said in a statement.

Capricor has won about $19.8 million in funding from California’s stem-cell agency, the California Institute for Regenerative Medicine (CIRM), toward the Phase II trial, through CIRM’s Disease Team Therapy Development-Research program. The trial will be designed to assess both safety and efficacy of a heart-derived stem cell product in patients who have experienced a heart attack either recently or in the past.

Capricor told CIRM its Phase I data suggest that treatment with the heart-derived cell product under development can turn scar tissue back into healthy heart muscle. The clinical program for CAP-1002 also builds upon earlier research for which Eduardo Marbán, M.D., Ph.D., director of the Cedars-Sinai Heart Institute, won an earlier $5.56 million Disease Team Research I grant from CIRM.

“The planned mid-stage trial will hopefully confirm that finding in a larger patient group and provide additional data to support the safety profile of the product,” the company stated in an abstract of the research published on CIRM’s website.

A successful Phase II trial would be followed by a Phase III study, then a marketing application to the FDA, Capricor added: “The end result could be an affordable stem cell therapy effective as part of a treatment regimen after a heart attack.”

Capricor became publicly traded in July following its merger with Nile Therapeutics, under which Capricor became a wholly owned subsidiary of Nile.

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