3SBio signed an exclusive license with Korean firm DiNonA for the development, manufacturing, and marketing of Leukotuximab, an anti JL-1 antibody for acute leukemia, acute myelocytic leukemia, and acute lymphoblastic leukemia. The territories of the deal include Mainland China, Taiwan, Hong Kong, Macau, and the Middle East (excluding Cyprus, Egypt, Israel, and Turkey).
In addition to an undisclosed upfront payment, milestone payments will be made after completion of technology transfer, approval of IND application by the China Food and Drug Administration, completions of Phase I to Phase III clinical trials, and marketing approval in China. 3SBio will also pay DiNonA a sales-based royalty.
Leukotuximab was developed by DiNonA researchers. The antibody targets JL-1 Ag, an epitope of human CD43 extracellular domain. According to the company, JL-1 is expressed on tumor cells of T, B, and myeloid lineages in more than 80% of acute leukemia 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 leukemic cells, DiNonA said anti-JL-1 mAb can be an excellent targeted reagent for treatment of the leukemia.
Leukotuximab also showed significant improvement in survival in leukemia animal models, according to DiNonA. The company said no evidence of toxicity was observed in study animals. An open label and dose-escalating Phase I clinical trial in Korea started in June 2014 and is expected to finish in late 2015. -