Novo Nordisk and Heartseed Dose First Patient in Phase I/II Trial of iPSC-Derived Cell Therapy HS-001 for Advanced Heart Failure

On February 10, Novo Nordisk and Heartseed jointly announced that they had successfully administered the cell therapy HS-4 (HS-001) to the first patient in the LAPiS study. The patient underwent a 4-week evaluation by an independent safety assessment committee prior to treatment.

HS-4 is a cell therapy developed by Heartseed for the treatment of heart failure. It consists of highly purified cardiomyocyte clusters (cardiomyocyte spheroids) derived from induced pluripotent stem cells (iPSCs). The expected mechanism of action is to integrate the transplanted cardiomyocytes with the patient's own cardiomyocytes, thereby improving cardiac output through muscle regeneration and secretion of angiogenic factors to form new blood vessels around the transplantation site. Preclinical studies have shown that iPSC-derived cardiomyocytes can improve cardiac function.

In June 2021, Novo Nordisk partnered with Heartseed to acquire the development, manufacturing, and commercialization rights of the product outside Japan for $598 million. The two companies will share the product's R&D costs and profits.

The LAPiS study is a 52-week Phase I/II dose-escalation study expected to enroll 10 patients, aiming to evaluate the efficacy and safety of HS-4 in treating patients with advanced heart failure caused by ischemic heart disease. The study is divided into two cohorts, one receiving 50 million cardiomyocytes and the other receiving 150 million cardiomyocytes. HS-001 will be transplanted into the diseased tissue of the heart during open-heart surgery and coronary artery bypass grafting. The primary endpoint is patient safety data at week 26, with secondary efficacy endpoints including left ventricular ejection fraction and myocardial wall motion.

Heart Failure: A Chronic Progressive DiseaseHeart failure is a chronic progressive disease that causes the heart muscle to be unable to pump enough blood to meet the body's demand for blood and oxygen. This condition leads to frequent hospitalizations for patients, and more than half of the patients will die within five years. Statistics show that there are over 650,000 cases of heart failure globally, with the most common triggers being heart diseases (such as ischemic heart disease, cardiomyopathy, or hypertension). Currently, there is no cure for this condition, and only medications that can slow down but not halt the progression of the disease are available.

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