WindMIL has an exciting clinical-stage pipeline that highlights the broad possibilities of our MILs™ platform. Leading the way are two Phase 2 programs in hematologic and solid tumors.
Multiple myeloma is a proliferation of malignant plasma cells and the most common cancer of the bone marrow. Despite recent advances in treatment of multiple myeloma, patients with a high-risk form of the disease (up to 30% of newly diagnosed patients) continue to have a very poor prognosis, with a median overall survival of under three years. Our MILs cell therapy could address the enduring, significant unmet need for high-risk multiple myeloma patients.
In a Phase 1 trial of MILs in difficult-to-treat multiple myeloma patients, MILs were able to demonstrate promising safety and efficacy. There was no cytokine release syndrome (a dangerous adverse event present in many other T-cell therapies) and no other major unexpected toxicities.
Currently there is an ongoing 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. This trial is fully enrolled and awaiting results of the primary endpoint, two-year progression-free survival. Early safety data is encouraging, 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.
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 second Phase 2 clinical trial will explore MILs as a cell therapy to treat patients with non-small cell lung cancer (NSCLC), a highly prevalent and deadly solid tumor cancer. This study, poised to start in mid-2019, will examine the safety and efficacy of MILs plus 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, while the trial will also evaluate safety, durability of response, progression free survival, and overall survival.
The pipeline also includes an exciting early clinical program with unmodified MILs for patients who relapse after allogeneic transplant and numerous preclinical efforts, including studying the viability of unmodified MILs for additional solid tumor indications in partnership with leading academic medical centers.
Further, WindMIL is making rapid progress in the area of genetically-modified cell therapies using our MILs platform. One example is CAR-MILs™, which would place CAR (chimeric antigen receptor) constructs into MILs derived from patients with solid tumor cancers.