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 - Seite 2

“We believe that NexImmune’s multi-antigen-specific product candidates, alone or in combination with other immunotherapies, offer the potential to benefit patients with challenging cancers such as AML, for which treatment options with meaningful benefit and tolerability has remained elusive. The safety profile of our product candidate to date also presents the potential to investigate trials in patients with lower burden disease where significant unmet need remains,” added Ms. Jones.

Study Design

The goals of the NEXI-001 Phase 1 clinical trial are to evaluate the safety, tolerability, immune response, and clinical activity of the antigen-specific CD8+ NEXI-001 T cells, as well as to inform the range of patient characteristics and to determine the recommended Phase 2 dose. The dose escalation phase of the study included patients who have relapsed acute myeloid leukemia (AML) post allo-HSCT and are refractory to salvage therapy. All patients in the study, except one, relapsed after, or were refractory to, subsequent salvage therapies (one to three prior therapies). A majority of patients had three-to-four adverse risk characteristics linked to poor prognosis in addition to poor prognostic patients with extramedullary disease.

Three dose-ascending cohorts of patients were enrolled in the study, with potential doses ranging from a single dose of 50 million NEXI-001 T cells to multiple doses of up to a total of 1.2 billion NEXI-001 T cells. To date, the maximum dose evaluated has been 600 million NEXI-001 T cells.

The study includes a lymphodepletion chemotherapy (Flu / Cy 30/300) following a baseline bone marrow biopsy. To date, 11 patients have completed the dose-limiting toxicity (DLT) period and one patient is currently ongoing in the first month of protocol treatment.

“I am very encouraged by the responses and the tolerability profile observed in these difficult-to-treat refractory patients,” said Dr. Monzr M. Al Malki, MD, Associate Professor of Hematology, Director of BMT and Transplant, City of Hope and an investigator for NEXI-001. “These patients are frequently fragile and lack effective and tolerable options. Responses for these patients, if any, are typically short-lived and there is an urgent need for better options. As highlighted in the ASCO poster, achieving and maintaining a durable clinical response in extramedullary disease is clinically meaningful and supports the potential of NEXI-001 to provide significant benefit to these patients.”