NeoImmuneTech Announces Final Topline Results of Phase 1b Study Combining NT-I7 with CAR-T Therapy

100% Best Overall Response Rate in High-Dose NT-I7 Cohort with Sustained response beyond 6-Month No Incidence of Severe Adverse Events (CRS or ICANS) Reported May 19, 2025 — ROCKVILLE, MD : NeoImmuneTech, Inc. (NIT or “NeoImmuneTech”), a T cell-focused immunotherapy company, today announced the final topline results from its Phase 1b clinical trial (NIT-112) evaluating NT-I7 (efineptakin alfa) in combination with CD19 targetingCAR-T therapies in relapsed/refractory Large B-cell Lymphoma (r/r LBCL). A total of 17 patients were enrolled in the study. The most notable outcome was observed in the high-dose NT-I7 cohort (480–720 μg/kg, n=8), with a 100% overall response rate (ORR). Among these, 75% (6 patients) achieved a complete response (CR), and 25% (2 patients) achieved a partial response (PR). These results mark an improvement over the previously presented interim data at the 2024 ESMO Congress (ORR 82%, CR 64%). Notably, 88% of patients (7 out of 8) maintained their response beyond 6 months, demonstrating the potential of NT-I7 to sustain CAR-T efficacy over time. In one case, a patient initially showed a partial response and later converted from PR to CR, further supporting the potential for durable long-term benefit with this combination. Based on these findings, the company has determined the recommended Phase 2 dose (RP2D) of NT-I7 to be 720 μg/kg. The safety profile also exceeded expectations. Cytokine release syndrome (CRS) and immune cell-associated neurotoxicity syndrome (ICANS) are serious immune-related adverse events commonly associated with CAR-T therapies, often requiring intensive care. However, in this trial, no incidence of CRS or ICANS were reported among any of the 17 patients after NT-I7, underscoring NT-I7’s ability to enhance therapeutic efficacy without increasing toxicity. The trial enrolled patients with r/r LBCL a who had previously been treated with approved CAR-T therapies, including Kymriah (Novartis), Yescarta (Gilead), and Breyanzi (BMS). NT-I7 was administered as a single dose on Day 21 following CAR-T infusion. Dr. John DiPersio, principal investigator of the trial and hematologic oncologist at Washington University in St. Louis, commented, “NT-I7’s impressive response rate reflects its convincing mechanism of action and its potential to improve the outcome for many individuals receiving CAR-T therapy.” NeoImmuneTech CEO Luke Oh stated, “This study confirms that the combination of NT-I7 and CAR-T therapy can help sustain anti-tumor activity over time in clinical settings. From multiple angles, the results demonstrate superior outcomes compared to CAR-T alone, marking a meaningful milestone for our pipeline.” He added, “We are currently in active discussions with global pharmaceutical partners and expect to expand these conversations during the upcoming BIO International Convention this June, where we have several partnering meetings scheduled.” NeoImmuneTech plans to host a briefing session for analysts to discuss these results in detail. The presentation materials will be made available on the company’s website. *** ENDS ***

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