Drug intelligence / Profile preview

NEXI-001

Development stage
Phase 2
Lead developer
NexImmune
Modality
TCR-Engineered T Cells → Engineered T Cells → Adoptive Cell Transfer → Cell Therapies
Administration
Intravenous
01

Overview

NEXI-001 is an investigational, non-genetically engineered, donor-derived cell therapy product composed primarily of allogeneic CD8+ T cells. These T cells are designed to target multiple leukemia-associated antigens—specifically Wilms tumor protein 1 (WT1), Preferentially expressed antigen in melanoma (PRAME), and Cyclin A1—that are commonly expressed on acute myeloid leukemia (AML) blasts and leukemic stem cells. The therapy leverages NexImmune’s Artificial Immune Modulation (AIM) nanoparticle technology to generate antigen-specific T cell populations with early memory subtypes for enhanced anti-tumor potency and persistence. NEXI-001 is administered intravenously and is being developed for the treatment of relapsed or refractory AML as well as myelodysplastic syndromes (MDS). It has also been explored in HPV-associated cancers including head and neck squamous cell carcinoma[1][2][4][7].

Other names
allogeneic CD8+ leukemia-associated antigens specific T cells
02

Targets

PRAME (Preferentially expressed antigen in melanoma)CCNA1-p/MHC-I (Cyclin A1-derived peptide/MHC class I complex)pMHC-I (Peptide–MHC class I complex)

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