drugset / Press release

NeoImmuneTech Highlights Potential to Overcome CAR-T Limitations at ASH 2025 NT-I7 Combination Enhances Both CAR-T Expansion and Persistence

2025-12-17 · NeoImmuneTech · original neoimmunetech.com ↗

Early clinical data indicate that NT-I7 may increase CAR-T expansion; the CD19 CAR-T, NT-I7 combination trial was presented in an oral session Triple combination of dexamethasone, NT-I7, and CAR-T maintains complete remission for over 100 days in preclinical models, demonstrating enhanced durability NT-I7 + CART highlighted as a potential Next-Generation CAR-T Treatment Strategy December 17, 2025 — ROCKVILLE, MD : NeoImmuneTech, Inc. (“NIT” or “NeoImmuneTech”), a T-cell-focused immunotherapy company, today announced results from the 67th American Society of Hematology (ASH) Annual Meeting, held December 6-9 in Florida, USA, where external investigators presented clinical and preclinical findings on its T-cell amplifier NT-I7(Efineptakin alfa)-CAR-T combination strategies in both an oral presentation and poster session. CAR-T therapies achieve high initial response rates in certain hematologic malignancies; however, a significant number of patients relapse within the first year following treatment. Meanwhile, greater CAR-T expansion and persistence is associated with improved response rates and more durable responses, leading to improved survival. NeoImmuneTech has been pursuing combination approaches with NT-I7, an IL-7–based investigational therapy designed to enhance T-cell expansion and persistence, to help address these inherent limitations. The Phase 1 study NIT-112, evaluating a single NT-I7 dose administered on Day 21 after CD19 CAR-T therapy, was presented orally by Dr. Zachary Crees, a medical oncologist and blood cancer specialist, at Washington University School of Medicine in St. Louis. In the study, 17 patients with LBCL received a single dose of NT-I7 following CD19 CAR-T infusion. NT-I7 demonstrated a favorable safety and tolerability profile across all dose cohorts. Preliminary analyses suggested that earlier post-CAR-T administration of NT-I7 may further optimize CAR-T expansion. Supporting this observation, the high-dose NT-I7 cohort (≥480 μg/kg, n=8) demonstrated a 100% ORR with sustained response in 88% at 6 months. In addition, the survival analysis also demonstrated encouraging signals with Kaplan–Meier–based Overall Survival (OS) results showing 100% survival at 6 months, 62.9% at 12 months, and 53.9% at 24 months, indicating durable long-term survival outcomes. Further analysis of the high-dose cohort is expected to provide more detailed insights into the clinical significance of these findings. Based on these findings, Dr. Crees noted that the follow-up Phase 1 study, NIT-126, is expected to begin enrolling patients in Q1 of 2026 to evaluate two NT-I7 doses administered on Days 10 and 31 after CAR-T infusion. He added that this approach has the potential to be a robust CAR-T combination strategy aimed at further enhancing the therapeutic performance of CAR-T therapy. The preclinical poster was presented by Dr. Xiuli Wang and her team at City of Hope. The data demonstrated that further amplifying IL-7 signaling through the combination of NT-I7 and dexamethasone can markedly improve CAR-T cell persistence and function. Dexamethasone upregulates IL-7 receptor (IL-7R) expression on CAR-T cells, while NT-I7 provides a long-acting IL-7 signal that supports prolonged CAR-T survival and activity. In mouse models, dual combinations of CAR-T + NT-I7 or CAR-T + dexamethasone showed relapse around Day 35. In contrast, the triple combination of CAR-T + NT-I7 + dexamethasone maintained complete remission for over 100 days, with higher CAR-T cell persistence observed in both blood and bone marrow. Dr. Donghoon Choi, Head of R&D at NeoImmuneTech, stated, “These ASH presentations represent an important milestone in demonstrating the potential of NT-I7 as a strategic combination partner CAR-T therapies. NT-I7’s mechanism of action also positions it well for next-generation modalities such as in-vivo CAR-T, and the growing body of clinical and preclinical evidence is expected to serve as a critical foundation for expanding future global partnerships.” Meanwhile, in addition to the ongoing NIT-126 study, an investigator-initiated trial is evaluating NT-I7 administered on Days 14 and 35 in multiple myeloma patients previously treated with the BCMA CAR-T therapy CARVYKTI ® . *** ENDS ***

The release as fetched from its publisher. neoimmunetech.com ↗