WindMIL Therapeutics has entered into a new clinical research collaboration with Bristol-Myers Squibb Company to evaluate the safety and efficacy of WindMIL Therapeutics’ marrow-infiltrating lymphocytes (MILs™) in combination with Bristol-Myers Squibb’s nivolumab (Opdivo®), a PD-1 immune checkpoint inhibitor, in patients with locally advanced unresectable or metastatic non-small cell lung cancer (NSCLC) who are refractory to, or have relapsed on, an anti-PD-1-containing regimen.

This open-label, multi-center Phase 2a clinical trial will assess the safety and efficacy of MILs alone and in combination with nivolumab. MILs - NSCLC™ is an adoptive cell therapy product produced via WindMIL’s proprietary process to activate and expand T cells derived from the bone marrow of NSCLC patients. The first three to six patients in this Phase 2a study will be treated with MILs - NSCLC only.  Following this, approximately 20 patients will be treated with MILs - NSCLC plus nivolumab. The study’s primary endpoint is objective response rate (ORR).

"WindMIL is pleased to announce this collaboration with BMS and are excited to be evaluating MILs - NSCLC with nivolumab in patients with non-small cell lung cancer," said Don Hayden, chairman and chief executive officer of WindMIL. "MILs have already shown a favorable safety profile and encouraging efficacy in patients with hematologic malignancies. Working together, we’re committed to finding ways to address the unmet needs of patients living with cancer."

Under the terms of the agreement, WindMIL will be the sponsor of the trial and Bristol-Myers Squibb will supply nivolumab for use in the study.

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