WindMIL has an exciting clinical-stage pipeline that highlights the broad possibilities of our MILs™ platform.
MILs™ (non gene-modified)
WindMIL’s most advanced clinical assets are a set of programs using non gene-modified MILs. Based on their broad tumor antigen specificity, high cytotoxicity, and very favorable safety profile, WindMIL believes there is significant potential for MILs in early lines of treatment.
Non-Small Cell Lung Cancer
Lung cancer is the second most common cancer in both men and women, accounting for 14% of all new cancers. Our Phase 2 clinical trial is exploring MILs as a cell therapy to treat patients with non-small cell lung cancer (NSCLC), a highly prevalent and deadly solid tumor cancer.
The open-label, single-arm, multi-center study was initiated in late 2019 and examines the safety and efficacy of MILs plus nivolumab (a PD-1 inhibitor) in patients with advanced unresectable and metastatic NSCLC who have progressed on an anti-PD-1 containing regimen. The primary endpoint of the trial is overall response and the trial will also evaluate safety, durability of response, progression-free survival, and overall survival.
WindMIL entered into a clinical research collaboration with Bristol Myers Squibb in late 2019 for this study. 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. In April 2020, enrollment in the combination therapy portion of the study was opened.
A Phase 2, randomized, multi-center trial exploring the potential of MILs as a natural source of cell therapy to treat patients with high-risk multiple myeloma with stem cell transplant was completed in 2019. This study, sponsored by Johns Hopkins University, showed a favorable safety profile, including no increased risk of adverse events beyond what is typically expected in multiple myeloma patients treated with high-dose melphalan conditioning and stem cell transplant. However, due to data quality issues, a meaningful efficacy analysis is not possible at this time.
The non-gene modified pipeline also includes an exciting early clinical program with MILs for patients who relapse after allogeneic transplant and numerous preclinical efforts, including a set of Phase 0 investigator-sponsored studies of MILs for patients with additional solid tumor indications in partnership with leading academic medical centers.
CAR-MILs™ (gene-modified MILs)
WindMIL is also making rapid progress in the area of genetically-modified cell therapies using our MILs platform. CAR-MILs™ place CAR (chimeric antigen receptor) constructs into MILs derived from patients with solid tumor cancers. With their enhanced CAR-based cytotoxicity (rapid tumor cell killing), continued native TCR activity against residual tumor cells (antigen escape variants), and improved persistence, WindMIL believes there is significant potential for CAR-MILs in high-burden tumors and in later lines of treatment.
WindMIL/University of Pennsylvania CAR-MIL Collaboration
In early 2020, WindMIL entered into a collaboration with Penn’s Center for Cellular Immunotherapies (CCI). Led by Dr. Carl June, CCI is a world-class initial partner for WindMIL’s CAR-MIL program.
The collaboration is exploring novel CAR-MILs in hematologic and solid tumor model settings and leverages both Penn and WindMIL expertise. Each party is committing resources and proprietary science to develop and preclinically test potential cell therapy treatments.