NexImmune, a clinical stage immunotherapy company developing novel T cell therapies, received Investigational New Drug (IND) clearance for the company’s first cellular therapy product. NEXI-001 is being developed for the treatment of acute myeloid leukemia (AML) or myelodysplastic syndrome (MDS) patients with relapsed disease after an allogeneic hematopoietic cellular transplant (allo-HCT).
Scott Carmer, NexImmune President and CEO, commented “we are excited to initiate clinical trials with NEXI-001, and to provide these patients with a promising new treatment option. NEXI-001 is a product that is meaningfully differentiated from other cellular therapies in that it contains multiple populations of antigen specific endogenous T cells with enhanced anti-tumor properties. Because of this, we are confident NEXI-001 could address key limitations observed with other cellular immunotherapies; specifically, tumor escape through single target down-regulation and tumor relapse due to diminished T cell persistence.”
The Phase 1/2 trial of NEXI-001 will begin enrolling patients at clinical sites across the United States, including Memorial Sloan Kettering, MD Anderson, The City of Hope, The Dana Farber Cancer Institute, and AdventHealth. The trial is a multi-center, dose-escalating, open-label, single-arm study evaluating the safety, tolerability and initial efficacy of adoptively-transferred donor-derived T-cells as a treatment for AML or MDS patients with relapsed disease after allo-HCT. The trial will evaluate two increasing dose levels, with three patients enrolled in each dose escalation cohort. After the initial safety evaluation phase, up to 20 patients will be enrolled in the dose expansion phase. All patients will be followed for at least one year.
Lee Greenberger, MD, Chief Scientific Officer at The Leukemia and Lymphoma Society, commented further, “patients who relapse after allo-HCT are left with a dismal prognosis and limited treatment options, and are in need of new treatments that offer significant benefit. LLS is proud to partner with NexImmune on the development of products like NEXI-001 through our Therapy Acceleration Program® (TAP). We believe this unique technology has the potential to meaningfully benefit patients who are in urgent need of novel approaches to treating this disease.”