China-based biotech 3SBio declared that it has signed into an exclusive license with DiNona for the development, production, and commercialization of Leukotiximab in China and the Middle East.
Leukotuximab is an anti-leukemic monoclonal antibody developed by DiNona against JL-1+ Acute Leukemia. The antibody targets the JL-1 Ag epitope expressed on tumor cells of leukemia patients, which is associated with hematopoietic malignancies.
Under the terms of the agreement, 3SBio will make an upfront payment to DiNona. Additional milestone payments will follow upon the achievement of certain conditions which include transfer of technology and completion of Phase I to III clinical trials in China. Upon approval of the drug’s Investigational New Drug (IND) filing with the China Food and Drug Administration (CFDA) and marketing authorization, 3SBio will also make milestone payments. In addition, DiNona will receive a sales-based royalty from the company. No further financial terms of the agreement were disclosed by either company.
Dr. Jing Lou, CEO of 3SBio said that the company anticipates advancing the drug into clinical trials in China in view of its collaboration with DiNona. “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.” Indeed, the company recently announced a similar license agreement with Selecta Biosciences for Pegsiticase, an investigational treatment for the treatment of gout.
The companies will market Leukotixumab in Greater China territory, which includes the Mainland, Hong Kong, Taiwan, and Macau. Middles East territories, which are also part of the licensing agreement, include Israel, Cyrus, Egypt, and Turkey.
Dr. Hyung-Geun Song, CEO of DiNonA, said, “Leukotuximab is a drug candidate with great potential to treat acute leukemia… We are looking forward to working with 3SBio to maximize this opportunity and benefit tens of thousands of Chinese patients suffering for acute leukemia and other severe diseases.”
The companies said an open-label and dose-escalating Phase I study for Leukotuximab began this June and is anticipated to be completed by next year.