NECVAX NEO1 / NEC Corp - LARVOL DELTA

Phase I/II study of neoadjuvant personalized vaccination with NECVAX-NEO1 in combination with pembrolizumab and chemotherapy in early-stage TNBC evaluating safety, immunogenicity, and clinical activity NCT06631092 (ESMO 2026) - P1/2 | No abstract available

Clinical • Combination therapy • P1/2 data • Oncology • Triple Negative Breast Cancer

Personalised Neoantigen-targeting Cancer Vaccine NECVAX-NEO1 in Neoadjuvant Triple-negative Breast Cancer (clinicaltrials.gov) - P1/2 | N=28 | Recruiting | Sponsor: NEC Bio B.V | N=12 ➔ 28 | Trial primary completion date: Dec 2026 ➔ Dec 2027

Enrollment change • Trial primary completion date • Breast Cancer • Neutropenia • Oncology • Solid Tumor • Triple Negative Breast Cancer

Personalised Neoantigen-targeting Cancer Vaccine NECVAX-NEO1 in Neoadjuvant Triple-negative Breast Cancer (clinicaltrials.gov) - P1/2 | N=12 | Recruiting | Sponsor: NEC Bio B.V | Trial completion date: Dec 2028 ➔ Dec 2029 | Trial primary completion date: Dec 2025 ➔ Dec 2026

Trial completion date • Trial primary completion date • Breast Cancer • Neutropenia • Oncology • Solid Tumor • Triple Negative Breast Cancer

Personalised Neoantigen-targeting Cancer Vaccine NECVAX-NEO1 in Anti-PD-1/PD-L1 Therapy in Patients With Solid Tumors (clinicaltrials.gov) - P1/2 | N=20 | Active, not recruiting | Sponsor: NEC Bio B.V | Recruiting ➔ Active, not recruiting

Enrollment closed • Neutropenia • Oncology • Solid Tumor

NECVAX-NEO1, a bacteria-based personalized neoepitope vaccine combined with PD-1/PD-L1 checkpoint inhibition in a phase I, open-label, multicenter: safety, immunogenicity and early efficacy signals. NCT05354323 (ESMO-IO 2025) - P1 | "The predictive performance of the NNPP software showed agreement with both immunological and clinical readouts.Conclusions The study demonstrates that the personalized neoepitope-based vaccine NECVAX-NEO1 in combination with PD-1/PD-L1 blockade is safe, immunogenic, and yields promising disease stabilization in a phase I metastatic setting. Biomarker responses align with clinical outcomes and predictive modeling, supporting further investigation in larger trials."

Checkpoint inhibition • Clinical • IO biomarker • Oncology • Solid Tumor

NEC Presents Phase I Results for Personalized AI-Powered Oral Cancer Vaccine NECVAX-NEO1 at ESMO Immuno-Oncology Congress 2025 (Newswire Today) - "In the phase I study, 6 patients with melanoma, renal cell cancer, or head and neck cancer, who have been on CPI treatment for at least three months, were treated with NECVAX-NEO1. The safety run-in phase showed no treatment-related toxicities, allowing a dose increase. Clinically, 83% of the patients achieved stable disease at the end of 24 weeks of treatment, which was followed by a 12 week follow-up period. In all patients immunogenic neoepitopes used in the vaccine, were detected, as demonstrated by ELISPOT analysis."

P1 data • Head and Neck Cancer • Melanoma • Renal Cell Carcinoma

NEC Announces Interim Results from Phase 1 Clinical Trial of NECVAX-NEO1, an AI-Driven Personalized Oral Cancer Vaccine, at ESMO Immuno-Oncology Congress 2024 (NEC Corporation) - P1 | N=15 | NCT05354323 | "NEC Bio Therapeutics today presents 24-week promising interim results from an ongoing Phase 1 basket clinical trial of an orally administered cancer vaccine, NECVAX-NEO1, used in combination with checkpoint inhibitors (CPI) for treating patients with solid tumors. The findings are being presented in a poster at the ESMO Immuno-Oncology Congress in Geneva, Switzerland from December 11 to 13, 2024.... The safety run-in phase showed no treatment-related toxicities, allowing a dose increase. An ELISPOT response was induced by 68% of neoepitopes, with 40% of patients showing significant neoantigen-specific signals. After a 24-week treatment period, 80% of patients had a stable disease status, indicating a high disease control rate."

P1 data • Head and Neck Cancer • Melanoma • Renal Cell Carcinoma

NEC, NEC Bio Therapeutics and AGC Biologics Form Partnership to Manufacture Personalized Cancer Vaccines for Clinical Trials - The two companies will work together to realize personalized treatment for cancer patients [Google translation] (Nikkei) - "NEC Bio Therapeutics...and AGC Biologics...have partnered to manufacture clinical trial vaccines for NECVAX-NEO1, a bacteria-based oral vaccine being developed by the NEC Group. The purpose of this partnership is to utilize the strengths of both companies in biotechnology to strengthen the production system for clinical trial vaccines aimed at realizing personalized cancer treatment."

Licensing / partnership • Oncology

NECVAX-NEO1 in Addition to Checkpoint Inhibitor in Patients With Solid Tumors (clinicaltrials.gov) - P1 | N=6 | Not yet recruiting | Sponsor: NEC OncoImmunity AS

Checkpoint inhibition • Monotherapy • New P1 trial • Head and Neck Cancer • Lung Cancer • Melanoma • Non Small Cell Lung Cancer • Oncology • Renal Cell Carcinoma • Solid Tumor • Squamous Cell Carcinoma of Head and Neck