Onconova Therapeutics Inc. (NASDAQ:ONTX) has in partnership with HanX Biopharmaceuticals, announced the commencement of Phase 1 clinical study of ON 123300 in China.
Onconova co-developing and co-commercializing ON 123300 in China
The company entered a development, commercialization, and registration agreement in December 2017 with HanX Biopharmaceuticals for ON 123300 on China. Part of the agreement included potential milestone payments in futures and royalties on sales as well as licensing fees for ON 123300 in China. Onconova still retains rights for ON 123300 outside china across the rest of the globe.
ON 123300 are a proprietary small molecule and dual ARK5 and CDK4/6 inhibitor, which is an important enzyme in controlling cellular energy homeostasis. Usually, ON 123300 inhibits ARK5 resulting in oncogene-altered energy metabolism collapse, which leads to programmed cell death. ON 123300 is different from approved CDK4/6 inhibitors in that it has shown single-agent toxicity for different cancer cells in preclinical trials that include colon cancer, breast cancer, multiple myeloma, and mantel cell lymphoma.
ON 123300 to improve the efficacy of approved CDK4/6 inhibitors
Steven M Fruchtman, the Chief executive Officer and president of Oncova, stated that since ON 123300 is a novel first in class anti-cancer agent, it has already demonstrated an exceptional dual-action mechanism that is likely to improve the clinical efficacy of the approved CDK4/6 inhibitors. Fruchtman also added that it could also impact the development of metastatic disease and also potentially mitigate the commonly observed adverse events based on the non-human studies that have already been conducted. He added that Oncova is looking forward to filing its US IND by the end of 2020 for ON 123300 and commence Phase 1 study in refractory solid tumors by Q1 2021.
Besides ON 123300 novel ARK5 and CDK4/6 inhibitor that is currently under preclinical development, the company has been advancing other anti-cancer agents meant to disrupt cellular pathways vital for cancer cell growth. Its oral rigosertib, a RAS pathway inhibitor, is currently in Phase 1/2 study combined with nivolumab in the treatment of KRAS and lung adenocarcinoma.