A Covid-19 Success, 300 Percent Stock Price Increase and the California Stem Cell Agency

A company that the California stem cell agency has backed with nearly $18 million scored big this morning on news that one of its products had generated a 100 percent survival rate with a small group of critically ill Covid-19 patients.

The company is Capricor, Inc., a publicly traded company based in Beverly Hills, Ca. Its stock soared more than 320 percent at one point this morning from its previous close of $2.41 based on the news about its CAP-1002 therapy. Shares stood at $9.09 at the time of this writing.  

The company said in a news release that it had generated "100 percent survival in critical Covid-19 patients who were treated with Capricor’s lead asset, off-the-shelf ('allogeneic') cardiac cell therapy CAP-1002, at Cedars-Sinai Medical Center as part of six compassionate care cases." 

The company said the federal government has approved 20 additional patients for treatment. Capricor also said it is developing "a randomized, placebo-controlled trial planned to treat patients with moderate and severe disease which is intended to be funded by non-equity capital."

Capricor and its underlying research have long been embedded with the state stem cell agency, which is formally known as the California Institute for Regenerative Medicine (CIRM). In addition to $17.8 million given directly to the company, another $7 million went to Cedars-Sinai for much of the early development work that led to the creation of Capricor. 

Speaking to the agency's governing board in 2016 concerning CAP-1002, CIRM director Jeff Sheehy, chair of its Science Committee, said, 

"This is pretty much a pure CIRM product. They came into our first disease team to develop the product. We've supported two of the three clinical trials. So if this turns out to be a major success, this will be a real feather for CIRM. We've been with them all the way. So I'm optimistic." 

In 2018, a clinical trial involving CAP-1002 was begun at UC Davis as part of CIRM's separate Alpha Clinics program, an ambitious statewide effort to lead the way nationally on stem cell research.

In a news release this morning, Linda Marban, CEO of Capricor, said, 

"As the global medical community continues to come together in its battle against COVID-19, the results of our initial compassionate care cases are extremely promising and what we had anticipated. We look forward to continuing to treat additional patients under our recently approved expanded access program Investigational New Drug application.

“CAP-1002 is an easy-to-deliver intravenous therapy that has been administered successfully to over 150 patients to date. Given its novel mechanism of action, it could be a potential game-changer in helping countless Covid-19 patients.”

The Capricor product initially targeted Duchenne muscular dystrophy (DMD), "a muscle wasting condition that steadily destroys the muscles in the arms and legs, heart and respiratory system" of boys and "never lets up," CIRM says.

The CAP-1002 treatment has demonstrated immunomodulatory properties that come into play with Covid-19. Capricor said, 

"Multiple published peer-reviewed studies of CDCs have demonstrated favorable modulation of various inflammatory cytokines and regulation of the immune response. The current understanding of Covid-19’s later stages are thought to be due to overstimulation of the immune system, which triggers a cytokine storm in which the body is overwhelmed with pro-inflammatory molecules. This immune response may become excessive and pathologic, inducing pneumonia, organ failure and death. Therefore, it can be the body's overreaction to Covid-19, rather than the virus itself, that delivers the fatal blow."

Capricor is also working on a Covid-19 vaccine involving a different technology.