WuXi Biologics, part of WuXi AppTec, a contract service provider, and its Chinese partner, Harbin Gloria Pharmaceuticals, have granted an exclusive license for their anti-PD-1 antibody, GLS-010, to Arcus Biosciences, a Hayward, California clinical-stage biotechnology company focused on cancer immunotherapies.

Harbin Gloria Pharmaceuticals contracted WuXi Biologics to discover and develop GLS-010 using the transgenic rat platform, OmniRat, of the San Diego-based biopharmaceutical company, Ligand Pharmaceuticals. GLS-010 is currently being evaluated in cancer patients in Phase I clinical studies in China. Arcus has licensed the exclusive development and commercialization rights of GLS-010 in North America, Europe, Japan, and other territories. Arcus plans on developing GLS-010 as a combination product with the other product candidates in its portfolio.

Under the agreement, Arcus will pay $18.5 million in upfront payments as well as development and regulatory milestones that could total up to $422.5 million for the development and approval of 11 products that include GLS-010 as a component. WuXi Biologics and its partner, Habin Gloria Pharmaceuticals, through an existing agreement will also receive commercial milestones of up to $375 million, which could result in aggregate payments from Arcus of $816 million. Arcus will pay tiered royalties that range from the high single-digits to low double-digits on net sales of GLS-010. In addition, WuXi Biologics and Arcus intend to enter into an exclusive three-year agreement for the development of Arcus’ biologics portfolio. WuXi Biologics also will be the exclusive manufacturer for GLS-010 in the licensed territories for a specified period of time.

In separate news, in August 2017, the US Food and Drug Administration completed the pre-license inspection of WuXi Biologics’ current good manufacturing practice manufacturing facilities (cGMP) with no critical findings for the production of TMB-355 (ibalizumab), an antibody for treating multiple drug-resistant human immunodeficiency virus-1. The 13-day inspection covered both drug-substance and drug-product facilities in the city of Wuxi, China.