NEC Bio Therapeutics, a company at the forefront of clinical strategy and trial management in oncology, has showcased impressive interim outcomes from a 24-week phase 1 trial of NECVAX-NEO1. This orally administered cancer vaccine, designed to work in tandem with checkpoint inhibitors (CPI), is being tested in patients with solid tumors. The results were highlighted in a poster session at the ESMO Immuno-Oncology Congress in Geneva, Switzerland, from December 11 to 13, 2024.
NECVAX-NEO1 stands out as a customized bacteria-based oral DNA vaccine, harnessing AI to predict the most potent patient-specific neoepitopes. Its primary aim is to stimulate the immune system, prompting T-cell responses that target and eliminate tumor cells by recognizing unique neoantigens.
In this phase 1 investigation, five subjects with melanoma, renal cell carcinoma, or head and neck cancer who received CPI for at least 12 weeks underwent treatment with NECVAX-NEO1. The initial safety phase revealed no toxicities linked to the treatment, enabling a dosage escalation. Notably, 68% of neoepitopes prompted an ELISPOT response, with 40% of patients demonstrating significant neoantigen-specific markers. Following a 24-week regimen, 80% of participants maintained stable disease status, indicating robust disease control.
On the study outcomes, Dr. Heinz Lubenau, CEO of NEC Bio Therapeutics, expressed, “We are encouraged by these initial proof-of-concept data, showcasing potential immunogenicity and related biomarker shifts in patients. This progress is promising against the backdrop of ongoing clinical trials for early and late-stage cancer patients across multiple venues. We eagerly anticipate more data to bolster NECVAX-NEO1’s role as a therapeutic avenue for challenging cancer cases.”
Motoo Nishihara, NEC Corporation’s Corporate Executive Vice President and CTO, added, “We are thrilled to unveil NECVAX-NEO1’s trial progress, which highlights safety and immune response signals. As NEC’s pioneering cancer vaccine in clinical development, it aligns with our goal of delivering innovative healthcare solutions globally through our advanced technologies.”
NECVAX-NEO1 is further assessed at additional trial sites across Lithuania, Germany, and Spain, which continue to enroll patients.
NEC Bio Therapeutics, situated in Mannheim, Germany, specializes in developing clinical strategies and conducting trials in oncology. It operates under NEC Bio, the biotechnology division of NEC Corporation.