Commercial Development of CGTs in Korea: Company Showcase

Bryan Choi, PhD
ISCT Asia Regional Vice-President
Inha University
Korea

Sudipto Bari, PhD
Co-Chair, ISCT Asia Regional ESP Subcommittee
National Cancer Centre
Singapore

Hyun-sook Park
CEO
CEFO Co. Ltd. 
Korea

Allogenic osteoblast-based cell therapy (CF-M801) for the treatment of the avascular necrosis of the femoral head

Osteonecrosis of the femoral head (ONFH) is a disease in which bone necrosis is caused by poor blood circulation in the femur. To treat ONFH, we developed CF-M801, pre-osteoblasts differentiated from umbilical cord mesenchymal stem cells (MSC) by optimizing the stiffness of hydrogels in three dimensions. CF-M801, distinguished from their undifferentiated MSC and from their differentiated osteocytes, has the dual function of osteogenesis and angiogenesis, necessary for bone regeneration. We further conducted the animal efficacy study of CF-M801 using the bone defect models of goat and mouse and the safety study of toxicity, biodistribution, and tumorigenicity. In phase 1 clinical trial, we confirmed the toxicity (DLT) and investigational efficacy in three doses. There was no adverse effects and no immune reaction for the last 3 months following after cell transplantation.

Dr. Park is a founder of Cell Engineering for Origin (CEFO bio). She commercialized allogenic bone cell therapy (CF-M801) for avascular necrosis of the femoral head using 3-D differentiation technology into osteoblasts from human umbilical cord-derived MSC. CF-M801 has finished cell transplantation in Phase 1. Exploratory efficacy is under study and there was no adverse effects and immune reaction. 

She obtained her BA in Biology and her MS in Genetics from Korea University, and her Ph.D in Cytopathology, from Imperial College School of Medicine in the UK (supervisor, Prof Nicholas A Wright). She was a visiting researcher at Cancer Research UK from 1990 to 1997. She proved the clonal spread of intestinal epithelium via crypt fission. Since returning to Korea, she had been investigating ex-vivo gene therapy for type 1 Diabetes Mellitus at the Korea Research Institute of Biotechnology and Biosciences (1997-1999), skin cell therapy for burn patients at Korea Cancer Center Hospital (1999-2005), production of human pluripotent stem cells with quality at MizMedi Hospital (2005-2007), commercialized autologous (Keraheal) and allogenic (alloheal) skin cell therapy and basic MSC-based cancer cell therapy of human glioblastoma (2007-2011).

She has been involved in many steering committees of basic research, and commercialization of regenerative medicine products of the multi-ministry committee, CDA, MFDS, Ministry of Science, ICT, and Future Planning and is a member of the board of directors of KSSCR, KSGCT and Genetics Society of Korea.

Bonghee Lee
CEO and Founder
Allogeneic iPSC-CAR-NK
nSAGE Inc. 
Korea

HARMONi-based allogeneic CAR-NK therapeutics for blood and solid cancers

nSAGE has developed HARMONi-platform for iPSC-CAR-NK therapeutics. HARMONi(Homogeneous Automated Reproducible Manufacturing of Next iPSC) with CAR modifications using CRISPR/Cas technology in amino acid level, nSAGE is targeting blood and solid cancers with our own highest specificity and efficacy.

Dr. Lee is a professor of Gachon University, Medical School and founder and CEO of nSAGE Inc.(next Stem cells by Advanced Gene Engineering) in Korea. nSAGE is the biomedical company pursuing global industrialization of allogeneic single-iPSC driven CAR-T/NK cancer therapeutics using CRISPR/Cas technology in Korea and US.

Seung Ho (Justin) Yoo
CEO
Adjunct Professor
Youth Bio Global
Korea

The Effectiveness of Xeno-Free Endothelial Progenitor Cells derived from cord bloods in Critical Limb Ischemia

Critical limb ischemia (CLI) is the most-severe clinical manifestation of peripheral arterial disease (PAD). The primary goal of therapy in CLI is to achieve blood flow to the distal limb vessels with angioplasty or bypass surgery. Our cultured Xeno-Free Endothelial Progenitor Cells (X-EPC) treat ischemic diseases by inducing angiogenesis promotion in critical limb ischemic (CLI) diseases. X-EPC can be cultured faster than conventional EPC (Late EPC) and increases cell survival rate. It also restores hind limb blood flow in critical limb ischemic animal model by vascular regeneration.

JUSTIN (SEUNG HO)YOO is CEO and FOUNDER at YOUTH BIO GLOBAL focusing on the universal healthcare service with the cutting-edge regenerative medicine to the patients who are suffering from the rare and incurable diseases. He is an adjunct professor at biomedical engineering department at Dongguk University and also lecturing at the school of medicine, Yonsei university and several universities, etc. While he was working for several types of vascular diseases at St. Jude Medical and ABBOTT, he had got Master degree with Health Policy Management (Health economics) and Ph.D.at the school of medicine, SEOUL National university. Establishing YOUTH BIO GLOBAL in 2017, he has been concentrating on the ischemic vascular diseases such as diabetic mellitus foot, critical limb ischemia, diabetic retinopathy and acute myocardiac infarction indications, etc using xeno-free EPC(Endothelial Progenitor Cells)derived from human umbilical cord blood. Closely working with the government bodies like MFDS and MOHW in Korea, he has been leading several working groups for the clinical evaluation and research as an advisor and also an evaluator for WERM, etc. He had got several awards from MFDS, MOHW, KHIDI, AHWP, NHIC & KMDIA, etc