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] (link is external) 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, MD, 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 contract research organization (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 UK.
About Sarah Cannon Research InstituteSarah Cannon Research Institute is the research arm of HCA Healthcare’s global cancer institute, Sarah Cannon. Focused on advancing therapies for patients, it is one of the world’s leading clinical research organizations conducting community-based clinical trials throughout the United States and United Kingdom. Sarah Cannon’s network of strategic sites includes more than 275 physicians who engage in research. The organization has led more than 300 first-in-man clinical trials since its inception in 1993, and has been a clinical trial leader in the majority of approved cancer therapies over the last 10 years.
Additionally, Sarah Cannon offers management, regulatory, and other research support services for drug development and industry sponsors as well as strategic investigator sites through its contract research organization (CRO), Sarah Cannon Development Innovations.
About Boehringer Ingelheim in OncologyBoehringer Ingelheim’s oncology research is driven by a passion to advance clinical practice and a determination to improve the lives of patients who are battling cancer. Through our own scientific innovation and partnerships, we are focused on discovering and providing novel best-in-class, breakthrough cancer medications that fit the needs of patients, caregivers and healthcare professionals. We have a clear strategy to become a leader in the field of lung cancer. Boehringer Ingelheim has successfully launched two products globally for non-small-cell lung cancer (NSCLC) that have been widely adopted and established as valuable additions to current clinical practice. Continuous insights and learnings from research and development are key parts of innovation and our way forward to advance clinical practice in lung cancer and other cancer types.
About Boehringer IngelheimInnovative medicines for people and animals have for more than 130 years been what the research-driven pharmaceutical company Boehringer Ingelheim stands for. Boehringer Ingelheim is one of the pharmaceutical industry’s top 20 companies and to this day remains family-owned. Day by day, some 50,000 employees create value through innovation for the three business areas human pharmaceuticals, animal health and biopharmaceutical contract manufacturing. In 2016, Boehringer Ingelheim achieved net sales of around 15.9 billion euros. With more than three billion euros, R&D expenditure corresponds to 19.6 per cent of net sales.
Social responsibility comes naturally to Boehringer Ingelheim. That is why the company is involved in social projects such as the "Making More Health" initiative. Boehringer Ingelheim also actively promotes workforce diversity and benefits from its employees' different experiences and skills. Furthermore, the focus is on environmental protection and sustainability in everything the company does.