On December 20, 2018 Xynomic Pharmaceuticals, Inc. ("Xynomic"), a clinical stage US-China oncology drug development company, reported that it 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 ("Boehringer Ingelheim") (Press release, Xynomic Pharmaceuticals, DEC 20, 2018, View Source [SID1234532253]).

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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.

According to a press release by World Health Organization (WHO)’s International Agency for Research on Cancer dated September 12, 2018, breast cancer is the most commonly diagnosed cancer and the leading cause of cancer death in women. In addition, colorectal cancer is the second most commonly diagnosed cancer and the third leading cause of cancer death in women and the third most commonly diagnosed cancer in men. According to IMS and iHealthcareanalyst, drugs treating these two malignancies are expected to generate annual revenue of approximately $25.4 billion by 2023.

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.