Tokyo — December 10, 2025 — NEC Bio Therapeutics presented results from a Phase I basket trial of NECVAX-NEO1, an orally administered personalized cancer vaccine, in combination with PD-1/PD-L1 checkpoint inhibitors. Findings were presented in a poster at the ESMO Immuno‑Oncology Congress in London, December 10–12, 2025.
NECVAX-NEO1 is a bacteria-based oral DNA therapeutic vaccine developed using AI to predict immunogenic, patient-specific neoepitopes. The vaccine is designed to induce T-cell responses that target tumor cells based on individual neoantigens.
In the Phase I safety run-in, six patients with melanoma, renal cell carcinoma, or head and neck cancer who had received checkpoint inhibitor therapy for at least three months were treated with NECVAX-NEO1. No treatment-related toxicities were observed, permitting dose escalation. At 24 weeks of treatment, 83% of patients achieved stable disease; a 12-week follow-up period was completed. ELISPOT analysis detected immunogenic neoepitopes used in the vaccine in all patients.
Dr. Heinz Lubenau, CEO of NEC Bio Therapeutics, said the Phase I data demonstrate promising immune responses and consistent translational biomarker and clinical readouts, and noted that two additional clinical studies are advancing in three European countries across early- and later-stage cancer settings.
Motoo Nishihara, Corporate Executive Vice President and CTO of NEC Corporation, said the trial demonstrates safety alongside signs of immunogenicity and early efficacy, and highlighted NEC’s AI predictive software that supports immunological and clinical readouts.
Poster title: NECVAX-NEO1, a bacteria-based personalized neoepitope vaccine combined with PD-1/PD-L1 checkpoint inhibition in a phase I, open-label, multicenter study: safety, immunogenicity and early efficacy signals. NCT05354323
Authors: D. Vaitiekus, E. Juozaityte, L. Puzauskienė, S. Tulyte-Kirzova, L. Gatijatullin, M. Platten, I. Poschke, I. Hülsmeyer, A. Kuhn, A. Aranguren, H. Lubenau, R. Stratford, T. Clancy, H. Fontenelle, B. Simovski, Y. Yamashita, C. Chaput, A. Meiser, V. Urbonas
Poster Number: 258P. Date: 10 December 2025.
Poster: https://www.nec-bio.com/en_DD/img/20251210_ESMO2025_NECVAX-NEO1_poster.pdf. Trial registration: NCT05354323.
NECVAX-NEO1 is also being evaluated at additional clinical sites in Germany, Spain and Lithuania.
About NEC Bio Therapeutics
NEC Bio Therapeutics, based in Mannheim, Germany, manages clinical strategy, development and execution of oncology clinical trials. It is a subsidiary of NEC Bio, the biotech arm of NEC Corporation, focused on personalized therapies and innovative biotechnological solutions. For more information, visit www.nec-bio.com.
About NEC Corporation
NEC Corporation provides IT and network technologies aimed at promoting safety, security, fairness and efficiency to support sustainable social value. For more information, visit https://www.nec.com.
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