Bristol-Myers Squibb Company announced that the company has entered into a five-year research collaboration with the Johns Hopkins University. The collaboration is designed to identify mechanisms of response and resistance in patients whose cancer is being treated with checkpoint inhibitor-based immunotherapies, including Opdivo (nivolumab) monotherapy, or Opdivo in combination with Yervoy (ipilimumab) or other investigational immunotherapies.

Under the collaboration, Bristol-Myers Squibb and Johns Hopkins’ scientists will launch an interdisciplinary research program that will study patient tumor samples in four primary research areas: characterization of tumor antigens and tumor antigen-specific T-cells, multifaceted profiling of the tumor microenvironment, assessment of microbiome components that modulate systemic anti-tumor immunity, and elucidation of novel tumor and immuno-metabolism factors that modify responsiveness to immunotherapy.

“This important collaboration with Johns Hopkins University, a leader in the field of translational Immuno-Oncology research, builds upon our strong working relationship and will enhance our scientific understanding of the role of various immunotherapies both alone and in combination, and at different points in the treatment continuum,” said Francis Cuss, MB, BChir, FRCP, chief scientific officer, Bristol-Myers Squibb. “We believe that findings from this research may help to inform the future of immunotherapy drug development as it relates to patient selection, clinical trial design and the identification of new biomarkers.”

“We’re at an inflection point of understanding the root causes of response and resistance to immunotherapy, and this collaboration will help propel the research needed to identify ways to expand immunotherapy effectiveness to more patients,” says Drew Pardoll, M.D., Ph.D., Director of the Bloomberg~Kimmel Institute for Cancer Immunotherapy.

Bristol-Myers Squibb and Johns Hopkins will also explore several early-stage clinical trials primarily focused on, but not limited to, the study of neoadjuvant immunotherapeutic interventions.

This agreement builds on the productive track record of collaboration between Bristol-Myers Squibb and the Johns Hopkins Kimmel Cancer Center- both leaders in the transformative field of Immuno-Oncology. Johns Hopkins is a founding member of the International Immuno-Oncology Network (II-ON), a global collaboration between Bristol-Myers Squibb and 13 academia centers that aims to further the scientific understanding of immuno-oncology. The two organizations also entered into an agreement in November 2015 as part of Bristol-Myers Squibb’s Immuno-Oncology Rare Population Malignancy (I-O RPM) program in the US.

Opdivo is a programmed death-1 (PD-1) immune checkpoint inhibitor that is designed to uniquely harness the body’s own immune system to help restore anti-tumor immune response. By harnessing the body’s own immune system to fight cancer, Opdivo has become an important treatment option across multiple cancers.

Opdivo’s leading global development program is based on Bristol-Myers Squibb’s scientific expertise in the field of Immuno-Oncology and includes a broad range of clinical trials across all phases, including phase 3, in a variety of tumor types. To date, the Opdivo clinical development program has enrolled more than 25,000 patients. The Opdivo trials have contributed to gaining a deeper understanding of the potential role of biomarkers in patient care, particularly regarding how patients may benefit from Opdivo across the continuum of PD-L1 expression.

In July 2014, Opdivo was the first PD-1 immune checkpoint inhibitor to receive regulatory approval anywhere in the world. Opdivo is currently approved in more than 57 countries, including the United States, the European Union and Japan. In October 2015, the company’s Opdivo and Yervoy combination regimen was the first Immuno-Oncology combination to receive regulatory approval for the treatment of metastatic melanoma and is currently approved in more than 47 countries, including the United States and the European Union.

Opdivo as a single agent is indicated for the treatment of patients with BRAF V600 wild-type unresectable or metastatic melanoma. This indication is approved under accelerated approval based on progression-free survival. Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trials.

Opdivo (nivolumab), in combination with Yervoy (ipilimumab), is indicated for the treatment of patients with unresectable or metastatic melanoma. This indication is approved under accelerated approval based on progression-free survival. Continued approval for this indication may be contingent upon verification and description of clinical benefit in the confirmatory trials.

Opdivo is indicated for the treatment of patients with metastatic non-small cell lung cancer (NSCLC) with progression on or after platinum-based chemotherapy. Patients with EGFR or ALK genomic tumor aberrations should have disease progression on FDA-approved therapy for these aberrations prior to receiving Opdivo. Opdivo is indicated for the treatment of patients with advanced renal cell carcinoma (RCC) who have received prior anti-angiogenic therapy.

Opdivo (nivolumab) is indicated for the treatment of patients with classical Hodgkin lymphoma (cHL) that has relapsed or progressed after autologous hematopoietic stem cell transplantation (HSCT) and post- transplantation brentuximab vedotin. This indication is approved under accelerated approval based on overall response rate. Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trials.