- R&D Pipeline
- Season 1 (2011-2020)
(KDDF-201212-01) Development and preclinical study of MD3 antibody therapeutics for induction therapy of allo-islet transplantation
Immunology, Protein
To develop an induction treatment for the suppression of adverse reactions resulting from allo-islet transplantation.
Pre-clinical efficacy tests for candidate antibodies, MD3 have been completed and IND approval is scheduled for completion in the near future.
The target patient group consists of Type 1 diabetes patients who require islet transplantation, and includes patients with adverse reactions to islet or pancreatic transplantation, as well as patients who require islet transplantation after a kidney transplant. Severe Type 2 diabetes patients who require insulin injections may also be suitable.
Unmet Medical Needs
The drop ratio for allo-islet transplants within one year or less has significantly improved to between 3 and 5 percent, as a result of the development of efficient immune modulation technology. However, long-term transplantation success over a period of one year remains disappointingly low. The ratio of insulin independent patients five years after islet transplantation drops to approximately 15 percent. A key cause of this phenomenon is toxicity arising from the prolonged injection of immunosuppressive preservers. There is a critical need for research and development to address this problem.
MCB was established, the whole processes related CMC was completely developed. GMP manufacturing for IND is going to conducted in Q3~Q4, 2015. Also, Non-human primate toxicity study will be ended up by Q1, 2016.
Patents: 2 registered
PCT Applications: 3
Scope/extent analysis currently being conducted in different countries
à Material: A candidate antibody highly specific for human ICAM-1 and an additional antibody that recognizes both primate and human ICAM-1.
à Indication: Adverse reaction of cell or organ transplantation, graft-versus-host reaction, autoimmune diseases.
○ Succeeded in transplanting the world’s longest pig islet into a diabetic monkey.
○ Induced antigen-specific T-cell immune tolerance in non-human primates.
○ Confirmed that the immune reaction toward infection in animals injected with MD-3 antibody was within the normal range and that CMV was not re-activated.
○ Throughout repeated primate tests, excellent efficacy and safety confirmed.
○ Treatment can be used for islet transplantation, and also as an indicant for solid-organ transplants, repression of the formation of anti-drug antibodies (ADA) and autoimmune diseases.
Allo-islet transplantation
Feb. 14, 2013~Feb. 13, 2015
Dinona
Lead Optimization