3SBio, a leading China-based biotechnology company focussed on researching, developing, manufacturing and marketing bio-pharmaceutical products, has entered into an exclusive licence with DiNonA Inc. for the development, manufacturing and marketing of Leukotuximab, an anti JL-1 antibody for acute leukaemia (AL), including acute myelocytic leukaemia (AML) and acute lymphoblastic leukaemia (ALL), in the territory of Greater China (including Mainland China, Taiwan, Hong Kong and Macau) and the Middle East (excluding Cyprus, Egypt, Israel and Turkey).
In addition to an upfront payment, milestone payments will be made after completion of technology transfer, approval of Investigational New Drug (IND) application by the China Food and Drug Administration (CFDA), completions of phase I to phase III clinical trials and marketing approval in China. 3SBio will also pay DiNonA a sales-based royalty. Additional terms of the licence are not being disclosed.
The incidence rate for AML is 1.6 per 100,000 annually; the incidence rate for ALL is 0.4 per 100,000 annually. In China, there are about two to three million existing AL patients. Among them, between 30,000 and 40,000 patients are newly diagnosed each year. Patients are currently treated with traditional chemotherapy and bone marrow transplant, both of which have major side effects.
Researchers from DiNonA have developed Leukotuximab, an anti-leukemic agent for JL-1+ acute leukaemia. This antibody is targeting JL-1 Ag, an epitope of human CD43 extracellular domain. JL-1 is expressed on tumour cells of T, B, and myeloid lineages in more than 80per cent of acute leukaemia patients, but not on mature peripheral blood cells or other normal tissues. Since the expression of JL-1 is highly associated with hematopoietic malignancies and is selectively expressed on the surface of human leukaemic cells, anti-JL-1 mAb can be an excellent targeted reagent for treatment of the leukaemia.
Leukotuximab showed significant improvement in survival in leukaemia animal models. Also, no evidence of toxicity was observed in study animals. An open label and dose-escalating Phase I clinical trial in Korea started at June 2014 and is expected to finish in late 2015.
"We are pleased to collaborate with DiNonA and look forward to moving Leukotuximab into clinical trials in China," Dr. Jing Lou, chief executive officer, of 3SBio commented, "3SBio continues to seek opportunities to support novel biologics, especially mAb candidates for blood cancer and other unmet medical needs, particularly in 3SBio's core therapeutic areas of oncology, nephrology and hematology."
"Leukotuximab is a drug candidate with great potential to treat acute leukemia," Dr. Hyung-Geun Song, chief executive officer, of DiNonA commented, "3SBio is an established industry leader in the innovative biological field in China, which makes them an ideal partner for long-term collaboration. We are looking forward to working with 3SBio to maximise this opportunity and benefit tens of thousands of Chinese patients suffering for acute leukaemia and other severe diseases."
DiNonA Inc. is a leading biotechnology company in Korea. DiNonA is focused on medication development for therapeutic antibodies, laser medical devices, and diagnosis/research agents. Leukotuximab, the leading candidate in its pipeline, has entered into Phase I trial in Korea. There are several other mAb candidates also under pre-clinical development.
Leukotuximab is an anti-leukaemic monoclonal antibody for JL-1+ Acute Leukaemia. The anti JL-1 antibody is targeting JL-1 Ag, an epitope of human CD43 extracellular domain. JL-1 is expressed on tumour cells of T, B, and myeloid lineages in >80per cent of acute leukaemia patients, but not on mature peripheral blood cells or other normal tissues. Since the expression of JL-1 is highly associated with hematopoietic malignancies and is selectively expressed on the surface of human leukaemic cells, anti-JL-1 mAb can be an excellent targeted reagent for treatment of the leukaemia.