WindMIL Therapeutics Opens Combination Therapy Portion of its Phase 2a Clinical Trial of Marrow-Infiltrating Lymphocytes (MILs™) for Treatment of Patients with Non-Small Cell Lung Cancer

Philadelphia, Pennsylvania, UNITED STATES

PHILADELPHIA and BALTIMORE, April 21, 2020 (GLOBE NEWSWIRE) -- WindMIL Therapeutics, a clinical-stage company developing marrow-infiltrating lymphocytes (MILs™) for cancer immunotherapy, today announced it has begun enrollment in the combination therapy portion of its open-label, multi-center Phase 2a clinical trial to assess the safety and efficacy of MILs 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. In this part of the study, MILs will be administered in combination with nivolumab, a PD-1 immune checkpoint inhibitor.

The trial, part of a clinical research collaboration with Bristol-Myers Squibb Company (NYSE:BMY) which is providing the nivolumab (Opdivo®), began late last year with the first set of patients treated with MILs™ - NSCLC only. 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 trial’s safety committee cleared the opening of the combination therapy portion of the study based on favorable safety data in the monotherapy part of the study. Only mild MILs related toxicities were observed, with no Grade 3/4 or dose limiting toxicities.

WindMIL plans to treat approximately 20 patients with MILs - NSCLC plus nivolumab in this next part of the study. The study’s primary endpoint is objective response rate, with duration of response, progression free survival and overall survival serving as secondary endpoints. The company has seven U.S. clinical sites activated for patient recruitment.

“We are excited to open the combination therapy portion of our trial for NSCLC patients who have relapsed on or are refractory to anti-PD-1 therapy,” said Don Hayden, chairman and chief executive officer of WindMIL. “Having the trial’s safety committee clear MILS for use in combination with nivolumab is an important milestone for our NSCLC program, and it further underscores the favorable safety profile observed with MILs in the treatment of more than 100 patients to date. We continue to see high physician and patient interest in our NSCLC study and WindMIL is doing all it can to support patients and physicians as they adapt to the challenging treatment environment COVID-19 has created. We remain committed to finding ways to leveraging our MILs technology platform to better address the unmet needs of patients living with cancer.”

Additional information on the trial can be found on 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. Distinguishing features of bone marrow T cells include their memory phenotype, inherent tumor antigen-specificity, higher CD8:CD4 ratio and ability to persist long term when compared to peripheral blood lymphocytes. 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. MILs are being investigated in clinical studies as ‘non gene-modified’ therapeutics and are under development as an alternative and potentially superior cell source to peripheral blood T cells for CAR-T therapy (CAR-MILs™). WindMIL believes that the unique aspects of the respective profiles of MILs and CAR-MILs position them in distinct areas of the oncology treatment landscape. WindMIL is currently studying the use of MILs to treat patients with non-small cell lung cancer, squamous cell carcinoma of the head and neck, breast cancer, 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 bone marrow-derived T cell therapies, 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:

WindMIL Therapeutics Media Contact:
Gina Cestari
6 Degrees
(917) 797-7904