WindMIL Therapeutics Presents New Marrow-Infiltrating Lymphocytes (MILs®) Data Demonstrating Broad Therapeutic Promise for Solid Tumor Cancers

On November 9, 2020 WindMIL Therapeutics, a clinical-stage company developing marrow-infiltrating lymphocyte (MILs) products for cancer immunotherapy, reported new data demonstrating the therapeutic promise for MILs as a potential cancer immunotherapy for a wide range of solid tumor indications at the Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper) 35th Anniversary Annual Meeting (Press release, WindMIL Therapeutics, NOV 9, 2020, View Source [SID1234570301]).

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In the study, bone marrow and blood samples were collected from patients with non-small cell lung cancer (NSCLC), prostate cancer, squamous cell carcinoma of the head and neck (SCCHN), glioblastoma (GBM) and breast cancer. Utilizing a 10-day proprietary process, MILs and peripheral blood lymphocytes (PBLs) were activated and expanded from all samples. T cell lineage-specific markers (CD3, CD4 and CD8) were characterized by flow cytometry pre-and post-expansion. Tumor antigen-specific T cells were detected in all of the expanded MILs (n=25) but none of the expanded PBLs. On average, 16.0% of CD4+ T cells and 26.8% of CD8+ T cells in MILs produced intracellular interferon-gamma (IFN-γ) following stimulation with matched tumor lysate-derived antigens. Additionally, expansion of MILs significantly increased the purity of T cells from 8.8–59.8% (mean 29.8%) in pre-expansion bone marrow to 92-99.6% (mean 96.3%) in post-expansion MILs.

"MILs were successfully grown for all solid tumor types evaluated, including NSCLC, prostate, SCCHN, GBM and breast cancer and expanded MILs from the bone marrow of all patients contained cytokine-producing shared tumor antigen-specific T cells. In contrast, the corresponding expanded PBLs from blood failed to show any detectable tumor-specific immune recognition," said Kimberly Noonan, PhD, Executive Vice President, Chief Scientific Officer and Co-Founder of WindMIL Therapeutics. "These data further underline our belief that MILs hold therapeutic promise across a wide range of solid tumor indications."

The bone marrow is a unique niche in the immune system to which antigen-experienced memory T cells traffic and are then maintained. WindMIL has developed a proprietary process to activate, transform and expand these memory T cells 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.

Don Hayden, chairman and chief executive officer of WindMIL, said, "This research builds on our momentum in developing MILs as a novel class of autologous cell therapies for cancer immunotherapy. We believe this study speaks to the compelling potential of MILs to become an important treatment option for patients with solid tumor cancers, a patient population broadly in need of more effective therapies."

A copy of the abstract can be viewed online through the SITC (Free SITC Whitepaper) website.

About Marrow-Infiltrating Lymphocytes (MILs)
Marrow-infiltrating lymphocytes (MILs) are manufactured through a proprietary process to activate, transform and expand T cells found in each patient’s bone marrow. Distinguishing features of bone marrow T cells include their memory phenotype, inherent 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, glioblastoma, renal cell carcinoma, urothelial carcinoma, 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.