NexImmune Presents Initial Positive Data from the NEXI-001 Phase 1 Trial for Relapsed/Refractory Post Allo-HSCT AML at the American Society of Clinical Oncology 2023 Annual Meeting

- Trial includes high risk AML patients that have relapsed post allo-HSCT and are refractory to salvage therapy

- NEXI-001 is well tolerated with a favorable safety profile, including no grade > 3 treatment related events as of May 2023

- Robust immune response with clinical activity at the highest dose level with one patient achieving no evidence of disease 7 months post-infusion with NEXI-001

- Antigen-specific T cells persist in blood and bone marrow and maintain important phenotypes that are associated with anti-tumor effect and immunologic memory

GAITHERSBURG, Md., June 05, 2023 (GLOBE NEWSWIRE) -- NexImmune, Inc. (Nasdaq: NEXI), a biotechnology company developing a novel approach to immunotherapy designed to orchestrate a targeted immune response by directing the function of antigen-specific T cells for liquid and solid malignancies, today announced results from its Phase 1/2 clinical trial of NEXI-001 in patients with relapsed/refractory acute myeloid leukemia (AML) post-allogeneic hemopoietic stem cell transplant (allo-HSCT). In this clinical trial to date, NEXI-001 is well tolerated with a favorable safety profile while eliciting an immune response to target antigens and a clinical effect in some patients. The data describing two patients from the dose escalation study of NEXI-001 are being presented in a poster session at the American Society of Clinical Oncology (ASCO) 2023 Annual Meeting in Chicago on Monday, June 5 at 8 AM in Hall A.

“We are pleased that NEXI-001, our donor derived multi-antigen-specific T cell product candidate, is demonstrating evidence of dose response and tolerability in the initial Phase 1 dose escalation portion of this clinical trial,” said Kristi Jones, NexImmune’s Chief Executive Officer.   “We have seen a clinical response maintained for seven months, which is an additional update from the data reported in our poster. These data have established the ability of our AIM nanoparticles to expand healthy, multi-antigen-specific T cells with anti-tumor activity. The data also show these T cells persist and maintain their memory phenotype at the site of tumor. We expect to provide an additional update on Cohort 3 later this year with more details from the patients in this study, and plan to apply learnings from this trial to inform future trials for NexImmune products in cancer.