RIDGEFIELD, Conn. & NASHVILLE, Tenn.—Boehringer Ingelheim and Sarah Cannon Research Institute announced in late October an expansion of their 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, alone and in combination with PD-1-directed cancer therapy.
According to Dr. Mehdi Shahidi, global medical head of oncology at Boehringer Ingelheim, “In September 2016, Boehringer Ingelheim and Sarah Cannon Research Institute announced their first strategic collaboration for a clinical development program studying 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, including non-small cell lung cancer (NSCLC). BI 754091 and BI 754111 are immune checkpoint inhibitors. Both programs are advancing nicely and we hope to present first results of our PD1 inhibitor study in a forthcoming conference in early 2018.”
“This collaboration [expansion] evaluates BI 891065, a novel and potent SMAC mimetic, alone and as a potential combination partner with PD-1-directed cancer therapy. [This] builds on our existing relationship with Sarah Cannon Research Institute,” Shahidi tells DDNews. “It combines our oncology research and Sarah Cannon’s expertise in clinical trial design and recruitment.”
SMAC mimetics are a new class of targeted small molecules that trigger tumor cell death and immune system activation, which 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 1 clinical trial (NCT03166631), both 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 1 study, which aims to include approximately 100 patients. Previously, the partners have collaborated in 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.
“Groundbreaking 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,” says 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 have demonstrated that [BI 891065], our SMAC mimetic, leads to the induction of immunogenic cell death and initiates and promotes an immunity cycle by enhancing dendritic cell and T cell mediated immune responses that result in tumor cell killing and tumor regression,” Shahidi notes. “These effects are potentiated by anti-PD-1 treatment, resulting in long-term tumor control.”
Through Sarah Cannon Development Innovations, a full-service, oncology-focused contract research organization, 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 United States and United Kingdom.
“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 Dr. Howard A. “Skip” Burris, president of Clinical Operations and chief medical officer at Sarah Cannon. “This expanded collaboration furthers our mission to provide access to the latest treatments for our patients.”
“We value our relationship with Sarah Cannon Research Institute and look forward to continuing our work with them,” says Shahidi. “Based on our synergies, we hope to bring more programs into this collaboration. We genuinely believe that partnerships with academia, industry and clinical research institutions like Sarah Cannon Research Institute are vital to innovation, as it can leverage talent and resources to speed research. So we are seeking more of these partnerships and more will be announced in the near future.”
“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. This program also underscores our strategy that combining cancer cell and immune cell targeted treatment may offer the best potential in treating cancer patients,” Shahidi concludes.