WindMIL Therapeutics Announces Dosing of First Patient in Phase 2 Clinical Study

WindMIL Therapeutics recently announced that the first patient has been dosed in the combination therapy portion of its Phase 2 clinical trial to assess the safety and efficacy of MILs – NSCLC 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 combination therapy dosing took place at Sarah Cannon Research Institute.

“We are excited to further explore how MILs – NSCLC can be used in combination with nivolumab to potentially strengthen immune responses in hard-to-treat cases of NSCLC,” said Melissa Johnson, MD, Associate Director of Lung Cancer Research and Drug Development with Sarah Cannon Research Institute at Tennessee Oncology. “Over the last few years, cellular therapies have emerged as a novel cancer treatment approach and we are eager to learn how it may help a patient population that continues to need better treatment options.”

The open-label, multi-center study will assess MILs – NSCLC in combination with nivolumab (Opdivo), an anti-PD-1 product. MILs – NSCLC is an adoptive cell therapy produced via WindMIL’s proprietary process to activate, transform and expand T cells derived from the bone marrow of patients with NSCLC. Nivolumab is being provided by Bristol Myers Squibb Company (NYSE:BMY) as part of a clinical research collaboration.

“Lung cancer makes up almost 25% of all cancer deaths and nearly 85 percent of lung cancer diagnoses are NSCLC,” said Martin J. Edelman, MD, the study’s principal investigator and chair of the Department of Hematology/Oncology at Fox Chase Cancer Center. “We need more effective treatments for those patients for whom frontline therapy has failed.”

WindMIL plans to treat approximately 20 patients with MILs – NSCLC plus nivolumab. The study’s primary endpoint is objective response rate, with duration of response, progression-free survival and overall survival serving as secondary endpoints. Second and third line patients who have failed an anti- PD-1 containing regimen have limited treatment options, with approved therapies having limited activity. Clinical paradigms have shown increased functionality, and decreased exhaustion, of T cells when exposed to anti-PD1​.

“WindMIL believes that NSCLC patients who have progressed or are even refractory to anti-PD1 therapy could benefit from an infusion of non-exhausted, memory-enhanced, antigen-specific MILs – NSCLC,” said Kim Noonan, PhD, Executive Vice President, Chief Scientific Officer and Co-Founder of WindMIL. “Our thesis is that the intrinsic anti-tumor activity of MILs – NSCLC in combination with an anti-PD1 could delay the induction of tumor-associated anergy and augment the overall effectiveness of immunotherapy for patients with NSCLC.”

“Addressing the unmet needs of patients living with cancer requires improved treatments,” said Don Hayden, Chairman and Chief Executive Officer of WindMIL. “We are energized by the opportunity to bring our novel, individualized therapy to patients with NSCLC.”

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

Marrow-infiltrating lymphocytes (MILs) are developed 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 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.

WindMIL Therapeutics is a clinical-stage company developing a novel class of autologous cell therapies based on marrow-infiltrating lymphocyte (MILs) products 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, transform 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.