BALTIMORE and PHILADELPHIA, Dec. 12, 2019 (GLOBE NEWSWIRE) -- WindMIL Therapeutics, a clinical-stage company developing marrow-infiltrating lymphocytes (MILs™) for cancer immunotherapy, today announced that the first patient has been dosed in a Phase 2a clinical trial to determine the safety and efficacy of MILs alone and in combination with an anti-PD-1 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. The first dosing took place at the Sarah Cannon Research Institute (Sarah Cannon) in Nashville, one of the centers participating in the study.

“We’re excited to bring this novel cell therapy approach to patients here at Sarah Cannon,” said Melissa Johnson, MD, associate director of lung cancer research at Sarah Cannon. “Investigating new treatment options for our patients continues to build hope for safer, more effective pathways to address this disease.”

This open-label, multi-center study will assess the safety and efficacy of MILs alone and in combination with an anti-PD-1. 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. Thereafter, the study protocol calls for approximately 20 patients to be treated with MILs - NSCLC plus an anti-PD-1 product. The study’s primary endpoint is objective response rate (ORR) and WindMIL plans to expand the study if sufficient activity is achieved.

“There is a clear unmet need when it comes to effective treatments for NSCLC and immunotherapy once frontline therapy has failed,” said Martin J. Edelman, MD, the study’s principal investigator and chair of the Department of Hematology/Oncology at Fox Chase Cancer Center, a participating study site, in Philadelphia. “Lung cancer is the second most common cancer and NSCLC accounts for up to 85 percent of all lung cancer diagnoses. Despite the enormous progress over the past few years, the basic truth is that the overwhelming majority of patients diagnosed with advanced lung cancer will die from their disease.”

This study builds on the broad clinical data set WindMIL has been assembling for its proprietary MILs platform. A Phase 2 study in high-risk multiple myeloma is approaching clinical readout and the company has several early-stage studies underway that explore the use of MILs in both solid tumor and hematologic indications.

“We believe that MILs have broad therapeutic potential in the solid tumor setting and we are excited to initiate this Phase 2 study in NSCLC for patients for whom anti-PD-1 regimens haven’t been effective,” said Don Hayden, chairman and chief executive officer of WindMIL. “This research will significantly advance our understanding of this novel class of autologous cell therapies for cancer immunotherapy.”

Additional information on the trial can be found on www.clinicaltrials.gov using the identifier NCT04069936.

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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