Capricor Therapeutics Inc.'s Stealthx exosome-based multivalent vaccine for the prevention of SARS-CoV-2 has been selected to be part of the U.S. Department of Health and Human Services' Project Nextgen initiative aimed at developing COVID-19 vaccines offering broader and more durable protection.
Multivalent vaccines that could improve SARS-CoV-2 immunity while also preventing infections by other viruses, such as influenza and respiratory syncytial viruses, constitute an urgent public health need. Currently approved vaccines against SARS-CoV-2 are based solely on the spike protein, which provides limited immunity against variations in spike.
With a potentially pivotal trial of its Duchenne muscular dystrophy (DMD) candidate CAP-1002 starting up, Capricor Therapeutics Inc. has tapped Nippon Shinyaku Co. Ltd. subsidiary NS Pharma Inc. to sell and distribute the cell therapy, pending U.S. FDA approval. The deal brings Capricor $30 million up front to fund the phase III trial, while also lining it up for as much as $705 million in milestone payments from its Japanese partner, which launched its own DMD therapy, Viltepso (viltolarsen), in the U.S. in 2020. Capricor shares (NASADQ:CAPR) rose 21.6% to $3.44 Jan. 25.
Capricor Therapeutics Inc. CEO Linda Marban said the company’s CAP-1002 for Duchenne muscular dystrophy (DMD) should serve as “adjunctive to any of the therapies out there” – a handful are approved – and bring bonus favorable effects on cardiac function that one analyst called “a one-two punch” against the disease.
Six of six critically ill COVID-19 patients survived after being treated as compassionate care cases with Capricor Therapeutics Inc.’s lead candidate, an off-the-shelf cardiac cell therapy. The success prompted the FDA to review the data and approve the company’s expanded access protocol for treating as many as 20 more COVID-19 patients.
