IPSC-Derived Cardiomyocyte Product to Treat Chronic Heart Failure Patients - Partnering Opportunity

Help Stem Cell Innovations (“HelpTx” or the “Company”; helptx.com.cn) is a Nanjing, China-based stem cell biotechnology company dedicated to developing finished allogeneic regenerative medicine products from induced pluripotent stem cells (iPSCs) to treat otherwise intractable diseases. Its lead product is designated HiCM-188, a first-in-class, iPSC-derived cardiomyocyte product produced by a patented process to treat patients with Chronic Heart Failure (CHF) in conjunction with or without coronary artery bypass (CABG) surgery, a market estimated to be $50 billion worldwide.

HelpTx has announced that it has appointed The Sage Group to support it global out-licensing program.

Drawing on the largest iPSC cell bank in China, CBiPS, the Chinese Bank of induced Pluripotent Stem Cells which is the only national iPSCs bank officially certified by the Chinese government and exclusively constructed and operated by HelpTx and led by an expert medical, scientific, and management team, HelpTx developed a proprietary production/QC process for HiCM-188 to produce a pure, high quality, standardized, and reproducible composition of cardiomyocytes. This process can be transferred to partners and its customers.

HiCM-188 has been studied in an investigator-initiated trial titled with “Treating Heart Failure With hPSC-CMs (HEAL-CHF)” ( ClinicalTrials.gov Identifier: NCT03763136) in China, and is now being extended into a Phase 1b/2a in China and US. Based on the fFirst-in-human study, conducted in conjunction with CABG, HiCM 188 clearly showed superior improvement in heart function compared to studies of other products as measured by ejection fraction, the 6-minute walk test, the New York Heart Association (NYHA) Classification, and the Minnesota Living with Heart Failure Questionnaire (MLHFQ). The results of this study are supported by very strong pre-clinical data in rats and non-human primates showing that the improvement from HiCM-188 is incremental to the improvement seen by CABG alone. This incremental effect of HiCM-188 over CABG is a main focus of the extended Phase 1b/2 study now underway

HelpTx seeks a partner for HiCM-188 and is working with The Sage Group to identify global and regional partners.