NexImmune Completes Dosing of First Cohort in Phase 1/2 Clinical Trial of NEXI-001 in Relapsed Acute Myelogenous Leukemia
September 23, 2020 at 01:30 pm
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NexImmune announced that it has completed dosing of the first safety cohort (n=3) in its Phase 1/2 clinical trial for NEXI-001, representing a significant milestone for the Company. NEXI-001 is a cellular product that contains populations of naturally-occurring CD8+ T cells directed against multiple AML-specific antigen targets, and it is the first clinical product generated by the Company’s AIM nanoparticle technology. The prospective, multi-center, open-label, single-arm, dose-escalating Phase 1/2 study will enroll between 22 to 28 patients. The primary objective is to assess the safety and tolerability of a single infusion of NEXI-001 T cells in patients with AML who have either minimum residual disease (MRD) or relapsed disease after a human leukocyte antigen (HLA)-matched allogeneic stem cell transplant (SCT). 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-001 T cells as measured in blood and bone marrow samples. Disease relapse after allogeneic SCT remains the major cause of treatment failure in patients with AML, is associated with very poor prognosis, and represents a major therapeutic challenge for physicians. Most commonly, patients with relapsed disease are given a donor lymphocyte infustion (DLI), but only 15%-20% respond to this approach while up to 60% experience life-threatening toxicities associated with GvHD. NEXI-001 products contain high proportions of T cells that are specific to leukemia cells and very low proportions of T cells (<5%) that have alloreactive potential (i.e., those associated with GvHD). NexImmune’s two lead T cell therapy programs, NEXI-001 and NEXI-002, are in Phase 1/2 clinical trials for the treatment of relapsed AML after allogeneic stem cell transplantation and multiple myeloma refractory to >3 prior lines of therapy, respectively. The Company expects initial data in the fourth quarter of 2020 for both indications. The Company’s pipeline also has additional preclinical programs, including cell therapy and injectable product candidates, for the treatment of oncology, autoimmune diseases, and infectious diseases.
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.