How is the stem cell and regenerative medicine biotech sector doing these days and does recent news about specific biotechs such as Capricor suggest issues for the sector more broadly?
Capricor had bad news earlier this year related to its stem cells for heart disease program and things just took a turn for the worse this week as pharma giant J&J severed ties with the small California company (here and here).
Capricor, which has received more than $17 million in CIRM grant funding, could have potentially received hundreds of millions from J&J if the deal had remained intact and if it had met key future milestones.
CEO Linda Marbán, pictured at right, reportedly emphasized the theoretical upside to this development:
“Capricor’s CEO Linda Marbán, Ph.D. accentuated the positive of claiming full rights to CAP-1002, including not only the DMD data but also work with Janssen on developing a commercial-scale manufacturing process for the cell therapy, to which it now has a “fully paid-up nonexclusive license.”
She also said it settled “uncertainty concerning the scope of the license for CAP-1002″ and frees the company to seek partners elsewhere.”
However, this is frankly terrible news for the company. It’s not a plus for CIRM either, which declined to comment when I asked them about it. While the planned new Capricor trial for Duchenne Muscular Dystrophy (DMD) is interesting, it’s a long haul ahead on that front for the company. I reported earlier this year on CIRM’s enthusiasm for Capricor’s DMD trial.
This all leaves me wondering whether in general the use of stem cells for some kind of heart disease will eventually be proven as a new form of cardiac medicine. I hope so. The two articles I cited above about this Capricor and J&J development go much further in their interpretation as they make the argument that the stem cell biotech sector overall is in bad shape and in addition assert that big pharma is losing interest. While that seems overly grim to me, at this moment in time things aren’t exactly very upbeat either in general with a few exceptions.
What stem cell biotech companies in the cardiac area seem most promising to you? What about stem cell biotechs more generally?
Disclosure: I have no financial interests in stem cell biotechs at present.
This may be very grim for many operating in this space – big pharma has been infected with the “lemming syndrome” for years – it is not uncommon for one company to give up on a specific therapeutic methodology and have it trickle through the rest – that being said, stem cell mono-therapy for cardiac indications for has so far been a bust – I think we still at a kindergarten phase in our understanding – Dr. Marban ‘s IMHO pr is a bit nutty too – “Yay! – we’re free from a $350 billion healthcare company to do other deals with our failed candidate!”
Hello, Admin:
Better stem cell science will accelerate progress in stem cell medicine. As long as stem cell therapy companies persist in designing and conducting clinical trials in which the dose and quality of treating stem cells is unknown, stem cell medicine will remain a caricature of its real potential. The well-known unknowns of stem cell medicine must become knowns for greater progress. “Count your adult tissue stem cells.”
Conflict of interest statement: Yes, Asymmetrex offers a contract service for providing the quality and dose of therapeutic tissue stem cells in treatment preparations.
James at Asymmetrex
asymmetrex.com
jsherley@asymmetrex.com
Cytori Therapeutics will be reporting Phase 3 data from their STAR trial within a few weeks. This could mark a pivotal change for the company as well as the regenerative medicine space.
sounds interesting, hope we will get more information about the results here