NeoImmuneTech Announces Continued Progress in CD19 CAR-T Combination Trial…Safety Confirmed in First Dose Cohort Following Two Doses of NT-I7

No dose-limiting toxicities observed in the first dose cohort (600 µg/kg) following two doses of NT-I7, completing DSMB review Study advances to Dose Level 2 (720 µg/kg) following DSMB review, with continued evaluation of the safety and tolerability of the repeat-dosing strategy September 21, 2026 — ROCKVILLE, MD : NeoImmuneTech, Inc. (“NIT” or “NeoImmuneTech”), a T-cell-focused immunotherapy company, announced that the Data and Safety Monitoring Board (DSMB) review has been completed for the first dose cohort (Dose Level 1, DL1; 600 µg/kg) in NIT-126 (NCT07052305), a Phase 1 clinical trial evaluating NT-I7 in combination with CD19 CAR-T therapy in patients with large B-cell lymphoma (LBCL). No dose-limiting toxicities (DLTs) were observed in the DL1 cohort. All patients in DL1 completed the DLT observation period without a DLT, and the study will therefore proceed to the next dose cohort, Dose Level 2 (DL2; 720 µg/kg), in accordance with the study protocol. Importantly, these results represent the first safety data for the repeat-dosing strategy, in which NT-I7 (efineptakin alfa) was administered beginning on Day 10 following CAR-T administration—earlier than the Day 21 single-dose schedule used in the prior NIT-112 study—and again on Day 31. No DLTs were observed in the DL1 cohort despite two administrations during the early activation period following CAR-T therapy, providing supporting evidence for the safety of the earlier combination and repeat-dosing strategy. NIT-126 is an investigator-initiated trial (IIT) evaluating the safety and tolerability of repeat dosing of NT-I7 following CAR-T therapy in patients with LBCL who have received FDA-approved CD19 CAR-T therapies. Zachary D. Crees, MD, of Washington University School of Medicine in St. Louis, serves as the principal investigator, with John F. DiPersio, MD, participating as a collaborating investigator. The study follows a 3+3 dose-escalation design across two dose levels, 600 µg/kg and 720 µg/kg. The trial is supported by Siteman Cancer Center, based at Barnes-Jewish Hospital and WashU Medicine, where Drs. Crees and DiPersio treat patients and where the trial is taking place. Upon final confirmation of the safety and tolerability of the repeat-dosing regimen during the ongoing dose-escalation stage, the Company plans to submit a separate protocol to the FDA for a future Phase 2 efficacy study. NT-I7, an interleukin-7 (IL-7)-based T-cell amplifier, has previously demonstrated safety and tolerability when administered as a single dose following CAR-T therapy in the NIT-112 CD19 CAR-T combination study. Building on these data, NIT-126 applies an earlier and repeat-dosing strategy to evaluate whether it can enhance immune recovery and the durability of anti-tumor immune responses following CAR-T therapy. “Completing the DSMB review without observed DLTs following two doses of NT-I7 in the DL1 cohort, and advancing to the next dose level, represents meaningful progress in validating our CAR-T combination strategy,” said Tae Kyoung Kim, Chief Executive Officer of NeoImmuneTech. “We will continue to systematically generate safety and tolerability data throughout dose escalation and further evaluate the potential of NT-I7 in combination with CAR-T therapy.” *** ENDS ***

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