Our Pipeline: NEXI-001 for Post-Transplant AML
NEXI-001 is a donor-derived, multi-antigen-specific T cell therapy built on NexImmune's AIM ACT platform. The program targets relapsed or refractory acute myeloid leukemia (AML) after allogeneic hematopoietic stem cell transplantation (allo-HSCT), a setting where treatment options remain limited.
Patients who relapse after allo-HSCT often have fragile immune systems and few approved therapies. NEXI-001 was designed to expand healthy, antigen-specific T cells that can recognize leukemia cells while preserving the memory and persistence needed for durable responses. The product is manufactured using AIM nanoparticles that function like synthetic dendritic cells, activating donor T cells against multiple leukemia-associated antigens without genetic modification.
Learn more about the underlying science on our AIM NT platform page or review the full company overview on the homepage.
How NEXI-001 Is Manufactured
AIM ACT manufacturing begins with an AIM nanoparticle cocktail containing tumor-specific antigens paired with NexImmune's enrichment and expansion system. Within approximately 14 days, this process yields populations of CD8+ antigen-specific T cells selected for potency and persistence. Because the cells are not genetically engineered, they retain natural target recognition and killing mechanisms, which NexImmune believes may reduce off-target toxicity compared with some engineered cell therapies.
For a visual overview of the ACT workflow, see our AIM ACT technology page.
Clinical Development Highlights
NEXI-001 advanced through a Phase 1/2 dose-escalation study in relapsed/refractory post-allo-HSCT AML. At the 2023 ASCO Annual Meeting, NexImmune reported initial data showing evidence of dose response and tolerability, including a clinical response maintained for seven months in an updated patient follow-up. Presentations also described T cell persistence and memory phenotype at the tumor site, supporting the AIM platform's ability to expand functional, multi-antigen-specific T cells.
Enrollment for AIM ACT programs, including NEXI-001, was later paused as the company prioritized its injectable AIM INJ modality and explored partnership options. Current program status and the broader pipeline are summarized on the pipeline overview page.
Common Questions About NEXI-001
Which patients was this program designed for?
NEXI-001 focused on adults with relapsed or refractory AML following allo-HSCT, a population with high unmet need and limited standard options after transplant failure.
What makes NEXI-001 different from other T cell therapies?
The product uses AIM-expanded donor T cells directed against multiple antigens rather than a single engineered target. Manufacturing relies on natural immune signaling rather than ex vivo genetic alteration of the T cell receptor.
Where can I find related publications?
Peer-reviewed work and conference abstracts involving the AIM platform are listed on our Abstracts and Publications page. Company announcements appear in the newsroom.