Boehringer Ingelheim and Sarah Cannon Research Institute announced an expansion of their strategic partnership to bring innovative treatments to cancer patients by developing novel immuno-oncology therapies. The new effort combines Boehringer Ingelheim’s oncology research and Sarah Cannon’s expertise in clinical trial design and recruitment to evaluate BI 891065, a novel and potent SMAC mimetic, alone and as a potential combination partner with PD-1-directed cancer therapy.

SMAC mimetics are a new class of targeted, small molecules that trigger tumor cell death and immune system activation that may enhance the activity of immunotherapies in the treatment of cancer. Through this collaboration, Boehringer Ingelheim’s BI 891065 will be studied in a Phase I clinical trial [NCT03166631] alone and in combination with BI 754091 (anti-PD-1) in patients with advanced metastatic solid tumors. The first patient has been enrolled in the Phase I study, which aims to include approximately 100 patients. Previously, the partners had announced a joint clinical development program to study Boehringer Ingelheim’s BI 754091 (anti-PD-1) and BI 754111 (anti-LAG 3) monoclonal antibodies for the combination treatment of multiple cancers with high unmet medical needs. More immune-oncology combination studies are planned moving forward.

“Ground-breaking advances in immuno-oncology are expected to transform cancer treatment paradigms. We are significantly expanding our efforts in this area including a broad research program focusing on the development of rational combinations of novel immuno-oncology approaches,” said Mehdi Shahidi, M.D., Global Medical Head Oncology, Boehringer Ingelheim. “As part of these ongoing efforts to transform the lives of cancer patients, we are extremely proud to be one of the first companies to bring this innovative combination therapy of an immune checkpoint inhibitor and a small molecule targeted treatment to the clinical stage of development,” added Shahidi.

Preclinical data, presented at the American Association for Cancer Research (AACR) Annual Meeting and the Keystone Symposia Conference on Molecular and Cellular Biology earlier this year, suggest that BI 891065 is a promising combination partner for checkpoint inhibitors and, when used together, may provide a new approach to cancer therapy.

“We look forward to continuing our research to find more effective therapies for patients across tumor types through novel immune therapies and combinations of therapies,” said Howard A. “Skip” Burris, M.D., President, Clinical Operations and Chief Medical Officer, Sarah Cannon. “This expanded collaboration furthers our mission to provide access to the latest treatments in the community for our patients.”

Through Sarah Cannon Development Innovations, a full-service, oncology-focused CRO, Sarah Cannon is providing comprehensive clinical development services and operational delivery of Boehringer Ingelheim’s early stage development programs. Expansion of the collaboration with Sarah Cannon, will enable rapid patient enrollment and expand access to Boehringer Ingelheim’s investigational oncology treatments through Sarah Cannon’s extensive network across the U.S. and U.K.