On January 26, 2022 Adlai Nortye Ltd. ("Adlai Nortye"), a clinical-stage biopharmaceutical company focused on the development of innovative cancer therapies, reported that it has entered into a Global License Agreement with Xiamen Biotime Biotechnology Co., Ltd. ("Biotime") for several compounds (Press release, Adlai Nortye Biopharma, JAN 26, 2022, View Source [SID1234607423]). This includes the rights and interests of Adlai Nortye in the development, manufacturing and commercialization of AN4005 and AN3025 in Greater China, and AN1005, AN6015 and AN9015 worldwide. According to the terms of the agreement, the total amount of this cooperation will reach hundreds of millions of yuan, including the upfront payments, progress-dependent milestone payments and tiered royalties on sales.
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According to Jianping Yu, the chairman secretary of Biotime, "Based on independent innovation, Biotime has started involving in innovative drug business, increased R&D investment, actively integrated into the global innovation network and focused on creating an innovation engine for high-quality development. The cooperation with Adlai Nortye, a leading brand of innovative drugs, will be a win-win attempt."
Dr. Nanhai He, the head of drug discovery of Adlai Nortye, said, "We are very happy to reach this agreement with Biotime, who has strong technical capabilities and scientific and technological strength, and puts a high value on product R&D and technological innovation. This cooperation will pave the way for the development and commercialization of several products, including AN4005 and AN3025, on a global scale, and benefit patients all over the world. We firmly believe that the partnership with Biotime will greatly accelerate the R&D and commercialization of these drugs."
About AN4005
AN4005 is an orally available, small-molecule PD-L1 inhibitor that demonstrates anti-tumor activity by the blockade of PD-1/PD-L1 interaction. In preclinical studies, AN4005 has demonstrated significant pharmacological activity, target affinity and acceptable safety profiles, which support the clinical development as a potential therapy for advanced malignancies. In pharmacology studies, AN4005 was shown to overcome the inhibition derived from PD-1/L1 interaction in hPBMC-based functional assays. Small molecule PD-L1 inhibitors are expected to provide several benefits over mAbs, such as, allowing for oral administration, lower production costs, improved tumor penetration, and lack of immunogenicity.
About AN3025
AN3025 is a novel humanized IgG1 (variant) anti-hTNFR2 antibody that is currently under preclinical study. This antibody binds to the extracellular domain of human TNFR2 with sub-nanomolar affinity and occludes its ligand TNFa from accessing TNFR2. Since TNFR2 is highly expressed on a subset of immunosuppressive cells, including regulatory T cells (Tregs) and MDSCs, within the tumor microenvironment, AN3025 is expected to amplify the antitumor immune response to aid in immunotherapy.