Help Therapeutics Announces IND Approval of First Universal iPSC-derived Cardiomyocyte Therapy for End-stage Heart Failure in China

BEIJING,Jan. 30,2023 -- Help Therapeutics Co.,Ltd. (hereinafter Help Therapeutics) has revealed that the China Center for Drug Evaluation (CDE) has approved the investigational new drug (IND) application of HiCM-188,a human (allogeneic) iPS cell-derived cardiomyocyte therapy in patients with worsening ischemic heart failure.

China CDE has approved Help Therapeutics to study the safety and efficacy of HiCM-188 implantation at various doses for clinical trials. HiCM-188,one of the leading pipeline programs of Help Therapeutics,is highly purified allogeneic cardiomyocytes (cardiac muscle cells),which are reprogrammed from human iPS cells,by using proprietary serum-free,genetic vector-free and integration-free conditions. The mechanism of action is that the transplanted cardiomyocytes electrically couple with the patient's myocardium to generate contractile force (remuscularization).

Heart failure (HF) is a major public health problem,with a patient population of at least 15 million in China and approximately 65 million worldwide. Because of its age-dependent increase in incidence and prevalence,heart failure is one of the leading causes of death and hospitalization among the elderly. "In addition to ongoing clinical trials in Japan and Germany,the IND approval of Help Therapeutics' iPSC-derived product HiCM-188 is an important milestone for the treatment of heart failure by using iPSC technology",said Professor Emerson C. Perin at The Texas Heart Institute. "These cells hold tremendous promise for development in the field of iPSC-driven cardiac regeneration technology."

"iPSC-cardiomyocytes might represent a useful adjunct to our current armamentarium of therapies for managing severe heart failure which,so far,has been largely restricted to experimental research and the regulatory approval of HiCM-188 is a critical step for moving this field closer to patient care",stated Professor Philippe Menasché from University of Paris Descartes.

"We are glad to be granted the first approval of an iPSC-based therapy for treating heart failure in China",said Dr. Eugene J. Wang,founder of Help Therapeutics. "Initiation of the HiCM-188 clinical trials based on our proprietary fully automated HELP Cell-foundry platform technology is a momentous milestone that represents years of research from global scientific pioneers as well as the tremendous focus and commitments of the Help team. We are thrilled to advance our Revolutionary Innovation treatment technology to helping HF patient populations with severely unmet medical needs."

About Help Therapeutics

Founded in 2016,Help Therapeutics is a globally clinical-stage biopharmaceutical company dedicated to the establishment of State National iPS Cell Bank as well as the development of first -in-class iPSC-derived cell therapeutics for patients with degenerative diseases. Help Therapeutics is committed to driving and empowering off-the-shelf cell therapy products in the fields of cardiac failure,other degenerative diseases,and oncology. At Help Therapeutics,we believe that the best way to deliver safe,effective and revolutionary cell therapy products is to provide superior development and manufacturing technologies,value and support at every stage of the journey to bring the next generation advanced therapies to patients in deed. To learn more,visit en.helptherapeutics.com.

Contact:

Susan Su,Head of External Cooperation,Help Therapeutics

susyh@helpsci.com.cn

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