Mononuclear Therapeutics (MonoTx™) Limited is a Biotechnology and Translational Medicine company that focuses on therapies based on cellular and non-cellular components found in umbilical cord blood and tissue. The Company’s primary focus is on neurological disorders, including chronic spinal cord injury (SCI), chronic stroke and age-related macular degeneration (AMD). Three million people have chronic SCI, 80 million people have chronic stroke, and 200 million people have AMD around the world. AMD is an eye disease that progresses over time and the leading cause of severe, permanent vision loss in people over age 60. The Company has close relationships with several premier research institutions in the USA and Hong Kong (HK) that conduct basic research, product development, and pre-clinical (animal) studies of these conditions. Discoveries in these institutions are transferred, validated and commercialized in MonoTx’s HK since 2016.
MonoTx HK began operations in 2016, and in late 2017, MonoTx started cord blood collection, processing, and banking to build mononuclear cell inventories for research and future therapeutic applications. In the last two years, MonoTx established the first public cord blood mononuclear cell bank in Hong Kong that is internationally accredited by Association for the Advancement of Blood & Biotherapies (AABB) and registered with the U.S. Food and Drug Administration (US FDA) Human Cell & Tissue Establishment Registry. In 2020, World Marrow Donor Association (WMDA), the world’s largest human hematopoietic cell registry, approved MonoTx application to list its cord blood cells for transplant physicians and patients to search and prescribe its HLA-matched cord blood cells for treatment. Recognition by these international organizations affirms the quality of MonoTx’s cells and indicate that MonoTx has met international clinical standards.
Dr. Wise Young founded and is the Chairman of the Board and Laboratory Director of MonoTx. At Rutgers University, he is the Richard H. Shindell Chair, Distinguished Professor of Cell Biology & Neuroscience, and Founding Director of the W.M. Keck Center for Collaborative Neuroscience. Dr. Young participated in and led many clinical trials since 1984, including Phase I & II clinical trials in the China Spinal Cord Injury Network, treating patients with chronic complete spinal cord injury (SCI) in Hong Kong and China. These trials showed that 75% of chronic complete SCI participants (15 out of 20) recovered long distance walking, bowel, and bladder function at one year after transplantation of umbilical cord blood mononuclear cells (MNCs).
Dr. Young also led the team that discovered and established high-dose methylprednisolone as the first effective therapy for acute spinal cord injuries. He developed the first standardized rat spinal cord injury model used worldwide for testing therapies, formed the first multicenter animal spinal cord injury study (MASCIS) funded by the National Institutes of Health (NIH) to test promising therapies, and established widely accepted animal and clinical outcome measures for spinal cord injury research. Dr. Young founded and served as editor-in-chief of the Journal of Neurotrauma, the leading journal of the field. In 1995, Dr Young co-founded Acorda Therapeutics, Inc. a Nasdaq listed company.
Ken Giacin is a co-founder of Mononuclear Therapeutics. After 25 years of senior management positions with Johnson & Johnson, Ken was recruited into the cell therapy and banking field where he spent over 16 years of global management and development in cord blood banking and cellular therapy. He served in leadership roles at StemCyte since 2003 as Chairman, CEO, and Vice Chairman, bringing world-class leadership to the company through new investment and technological affiliations. Before joining StemCyte, Ken had an outstanding and diverse career with Johnson & Johnson that spanned almost 26 years.
Mr. Giacin has also served on several Boards and Advisory Panels including Vice President of the Cord Blood Association, Board member of Cerebral Palsy of New Jersey, Advisory Board of the Human Engineering Research Laboratory of the University of Pittsburgh, Industrial Advisory Committee to Rutgers University, Advisory Committee of the National Institute for Child Health and Development (NIH), and Advisory Board of the Pan Pacific Symposium for Stem Cell Research.
John Horvath is a Partner at EisnerAmper, LLP. He was the President and a founding member of Horvath & Giacin, P.C. He has been a CPA for over 30 years, with experience in private and public accounting.
In the world of private accounting, he served as a division controller for a Fortune 100 company. In public accounting, he specializes in mergers and acquisitions of businesses in various industries.
Mr. Horvath is a founding member and incorporator of The Bank of Princeton (TBOP), a Princeton, New Jersey-based bank founded in 2007. TBOP is now a billion-dollar bank that went public on the NASDAQ exchange in 2017. Additionally, Mr. Horvath participates in various phases of capital raises for startup companies.
Dr. Chi Kong Li is Professor and Chief of the Division of Hematology/Oncology/Bone Marrow Transplant (BMT), Department of Pediatrics, the Chinese University of Hong Kong. Dr. Li completed general pediatric training in Hong Kong in 1981 and then specialized in pediatric Hematology/oncology/BMT, with further training at John Radcliffe Hospital, Oxford, and Great Ormond Street Hospital, London 1986, and Fred Hutchison Cancer Research Centre, Seattle in 1992.
Dr. Li’s main clinical interest is in childhood leukemia, hematopoietic stem cell transplantation, and thalassemia. He is the study chair for acute lymphoblastic leukemia trials in Hong Kong and the local coordinator for several international multicenter studies. He introduced new treatment methods for Hong Kong children, including double-unit umbilical cord blood transplantation and Metaiodobenzylguanidine (MIBG) treatment for neuroblastoma.
Dr. Li is also actively involves in the development of pediatric oncology in mainland China. He was Vice Chairman of China Children Cancer Group and is Vice-Chairman of the Steering Committee for two consecutive multicenter leukemia studies in China.
Currently, he is the immediate-past President of the Asia Continent of the International Society of Pediatric Oncology. In recent years he has been actively involved in developing cellular therapy in Hong Kong.
Mr. Lu has over 25 years of leadership roles in commercial operations in pharmaceuticals, stem cell banking, and therapeutics. He is skilled in business building, marketing and sales strategy, and implementation for traditional and regenerative therapies. He is ex-Janssen (Part of Johnson & Johnson) sales and marketing professional, where he started his career after earning his MBA in 1993. Mr. Lu started his business career in pharmacy chain stores in Taiwan in early 2000. He started with 3 stores and expanded to the chain to 15 stores within three years. It has since become a successful pharmacy chain store with over 100 stores, Taiwan-wide. Mr. Lu joined StemCyte Taiwan in 2004 as President where he led the Company to profitability and grew the business to be ranked 3rd in the market place in 3 years. From 2013 to 2020, he ran both U.S. and Taiwan operations of StemCyte.
Mr. Lu has also served on several Boards and Advisory Panels, including Board Director of the Cord Blood Association, member of the Advisory Committee to NMDP (National Marrow Donor Program) and the Advisory Committee to Taiwan’s Stem Cells Association.
Dr. Wendy Cheng has 20 years of experience in clinical trial and project management. Dr. Cheng holds a Ph.D. degree in Chemistry from the Hong Kong University of Science and Technology. Dr. Cheng is also a certified Associate of Clinical Research Professionals (CCRA) and a Project Management Professional (PMP).
Before Mononuclear Therapeutics Limited, Dr. Cheng served as Vice President of the China Spinal Cord Injury Network responsible for managing human clinical trials for spinal cord injury, including the first safety and efficacy studies of cord blood mononuclear cell transplant for chronic complete spinal cord injury in Hong Kong and China.
MonoTx™ facility at the Hong Kong Science Park is designed and equipped for umbilical cord blood mononuclear cell (MNC) processing, testing, storage, and distribution for clinical and research applications.
The facility has a Grade C cleanroom and Grade A biological safety cabinets to process cord blood. The cleanroom is NEBB certified and complies with ISO14644 air quality requirements.
The facility is equipped to test cord blood products. Each processed cord blood unit is assessed for cell types and cell numbers, cell viability, ability to produce colony forming units, and to determine microbial contamination.