Neximmune, Inc. Announces Dosing of First Patient in NexImmune Phase 1/2 Clinical Trial of NEXI-002 in Multiple Myeloma
October 06, 2020 at 08:30 am EDT
Share
NexImmune, Inc. announced that it has dosed the first patient in its Phase 1/2 clinical trial for NEXI-002. NEXI-002 is a patient-derived cellular product that contains populations of naturally-occurring CD8+ T cells directed against several multiple myeloma (MM)-specific antigen targets. It is the second clinical product NexImmune has generated with its AIM nanoparticle technology. Investigators will enroll between 22 to 28 patients in the prospective, multi-center, open-label, single-arm Phase 1/2 study. The trial’s primary objective is to assess the safety and tolerability of a single infusion of NEXI-002 T cells in patients with MM who have failed at least three prior lines of therapy. Secondary objectives include signals of anti-tumor activity, progression-free survival (PFS) and overall survival (OS). Additional analysis will assess the in vivo persistence, proliferation, functionality and T cell receptor (TCR) repertoire of NEXI-002 T cells as measured in blood and bone marrow samples. Clinical sites participating in this trial include Dana Farber Cancer Institute, Karmanos Cancer Institute, MD Anderson Cancer Center, City of Hope Comprehensive Cancer Center and Memorial Sloan Kettering Cancer Center. Despite recent advances in the treatment of multiple myeloma, there remains no cure for the disease. Virally-transduced CAR-T products that target the BCMA protein represent a new and promising form of genetically-engineered T cell therapy for multiple myeloma patients who have failed >3 lines of prior therapy, but unfortunately, a majority of patients who initially respond to these therapies relapse within one year of treatment. Because the T cells in NEXI-002 products can attack several multiple myeloma tumor-specific targets simultaneously and are comprised of T cell subtypes that can survive for years in patients, they have potential to address the limitations of current single-target genetically-engineered T cell therapies.
NexImmune, Inc. is a clinical-stage biotechnology company. The Company is engaged in developing an approach to immunotherapy designed to employ the bodyâs own T cells to generate an immune response that mimics natural biology. Its product candidates include NEXI-001 in acute myeloid leukemia (AML); NEXI-002 in multiple myeloma (MM), and NEXI-003, a solid tumor product candidate for Human papillomavirus (HPV) related cancers. The Company provides Artificial Immune Modulation (AIM), which is a nanoparticle technology platform. Its AIM technology enables it to construct nanoparticles that function as synthetic dendritic cells capable of directing a specific T cell-mediated immune response. The AIM nanoparticles employ signaling proteins to deliver instructions to T cells directing a desired immune response. The Company is also developing new AIM nanoparticle constructs and modalities for clinical evaluation in oncology and autoimmune disorders.