Fresh off $598M deal with Novo Nordisk, a Japanese stem cell company is on its way to the clinic with a different approach to treating heart failure
A common approach to treating heart failure with induced pluripotent stem cells involves grafting sheets of cells onto the surface of the heart to improve vascularization and blood flow. It’s the easiest method of transplantation — but you run the risk of not making an electrical connection with the heart and the cells not synchronizing with the patient’s heart muscle.
So what if you could inject spherical clusters of heart cells directly into the heart muscle wall? For Heartseed, that’s now the $37 million question.
The Tokyo-based biotech unveiled a modest Series C round on Friday morning, bringing its total raise to about $75 million. The news comes just a week and a half after Novo Nordisk struck an up to $598 million deal for exclusive rights to develop, manufacture and commercialize the company’s lead candidate HS-001 worldwide, except in Japan where Heartseed is keeping the development rights.
Heartseed is run by Keiichi Fukuda, a professor in Keio University’s department of regenerative medicine and advanced cardiac therapeutics and a longtime researcher. It’s named after a species of houseplant which resembles the spherical microtissue of heart cells the team creates in the lab.
HS-001 consists of donor iPSC-derived cardiomyocyte spheroids. Pluripotent essentially means the cell can be differentiated into any cell you want. And in Heartseed’s case, it’s cardiomyocytes — the cells responsible for generating contractile force in the heart.
The biotech injects the cardiomyocyte spheroids directly into the myocardium, where they grow and electrically couple with other heart cells.
Back in March, the company got the OK from Japan’s Pharmaceuticals and Medical Devices Agency to begin a Phase I/II trial, dubbed LAPiS, in severe heart failure associated with ischemic heart disease. The trial is expected to begin in the second half of this year.
The Novo deal includes $55 million in upfront and near-term milestone payments, and if the drug gets approved, Heartseed is eligible for “single-digit to low double-digit” royalties on annual sales outside Japan. Novo Nordisk has the rights to co-commercialize the drug in Japan, where it would split the profits and cost 50/50 with Heartseed.
“We believe that the partnership with Novo Nordisk is very valuable as we seek to disseminate our Japan-origin innovation globally as early as possible,” Fukuda said in a statement at the time.
The news comes about a year and a half after Heartseed pulled in a $26 million Series B round. A slate of new and old investors participated in the Series C, including UTokyo Innovation Platform Co., Medical Incubator Japan, Keio Innovation Initiative, Sumitomo Mitsui Trust Investment, SBI Group, Nissay Capital, SMBC Capital, Medipal Holdings, and Itochu Chemical Frontier.