Xynomic Pharmaceuticals, Inc., a clinical stage US-China oncology drug development company, has been granted an exclusive, worldwide license to develop, manufacture and commercialize BI 860585, a phase 2 ready mTORC1/2 inhibitor, from Boehringer Ingelheim International GmbH. 

BI 860585 is a potent and selective ATP-competitive mTOR serine/threonine kinase inhibitor.  It has been tested in a phase 1 trial with 90 patients with advanced solid tumors as single agent, in combination with exemestane or paclitaxel. In this trial BI 860585 was well tolerated and disease control rates (partial response plus stable disease) were 20%, 28% and 58%, respectively.

Xynomic plans to initiate 2 clinical trials in the next 6-9 months, among which, one is a potentially pivotal phase 2 trial combining BI 860585 with a standard-of-care treatment against breast cancer and the other is a phase 1b trial combining BI 860585 with Xynomic's XP-102 (formerly known as BI 882370) against colorectal cancer.

Total payments of Xynomic associated with the licensing agreement, including an upfront payment, regulatory milestone payments and potential royalties, will be up to $800 million.