BALTIMORE and PHILADELPHIA, Dec. 19, 2019 (GLOBE NEWSWIRE) -- WindMIL Therapeutics today announced it has entered into a new clinical research collaboration with Bristol-Myers Squibb Company (NYSE:BMY) 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.
About Marrow-Infiltrating Lymphocytes (MILs™)
Marrow-infiltrating lymphocytes (MILs™) are developed through a proprietary process to activate and expand memory T cells found in the bone marrow into MILs. Because memory T cells in bone marrow occur as a result of the immune system’s recognition of tumor antigens, MILs are specifically suited for adoptive cellular immunotherapy and directly eradicate or facilitate eradication of each patient’s unique cancer. WindMIL is currently studying use of MILs to treat patients with multiple myeloma, non-small cell lung cancer, squamous cell carcinoma of the head and neck, and glioblastoma, and plans to expand into other solid tumors. To date, more than 100 patients have received treatment with MILs and ongoing studies continue to build upon the favorable safety profile and promising efficacy seen in early development.
About WindMIL Therapeutics
WindMIL Therapeutics is a clinical-stage company developing a novel class of autologous cell therapies based on marrow infiltrating lymphocytes (MILs™) for cancer immunotherapy. As the leader in cellular therapeutics emanating from bone marrow, WindMIL translates novel insights in bone marrow immunology into life-saving cancer immunotherapeutics for patients. The company’s proprietary process to activate and expand these cells offers unique immunotherapeutic advantages, including inherent tumor-specificity, high cytotoxic potential and long persistence. For more information, please visit: https://windmiltx.com.
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