NEC Bio Therapeutics has announced promising interim results from its ongoing Phase 1 basket clinical trial of NECVAX-NEO1, an orally administered cancer vaccine. The trial, which combines NECVAX-NEO1 with checkpoint inhibitors (CPI), is evaluating the treatment of patients with solid tumors. The data, presented at the ESMO Immuno-Oncology Congress, reveals encouraging signs of immunogenicity and disease control.
NECVAX-NEO1: A Personalized Approach
NECVAX-NEO1 is a personalized bacteria-based oral DNA therapeutic vaccine developed using AI to predict the most immunogenic patient-specific neoepitopes. The vaccine is designed to activate the patient’s immune system, prompting a T-cell response that can precisely target and eliminate tumor cells based on the individual’s unique neoantigens.
Phase 1 Trial Results
The Phase 1 study included five patients with melanoma, renal cell cancer, or head and neck cancer who had been on CPI treatment for at least three months. The safety run-in phase showed no treatment-related toxicities, allowing for dose escalation. Notably, an ELISPOT response was induced by 68% of neoepitopes, with 40% of patients demonstrating significant neoantigen-specific signals. After a 24-week treatment period, 80% of patients achieved stable disease status, indicating a high disease control rate.
Expert Commentary
"We are very excited about our first proof-of-concept data showing signs of promising immunogenicity and associated biomarker changes in patients," said Dr. Heinz Lubenau, CEO of NEC Bio Therapeutics. "This is very encouraging, especially in light of new clinical trials currently ongoing at various locations in early and late-stage cancer patients. We are looking forward to generating more data for NECVAX-NEO1 as an additional treatment option for patients with difficult to treat cancer in the future."
Motoo Nishihara, Corporate Executive Vice President and CTO of NEC Corporation, added, "We are certainly excited to present the progress of the NECVAX-NEO1 trial demonstrating safety and signs of immunogenicity... This development ties in with the larger NEC mission of providing healthcare solutions globally using the state of art technologies developed in-house."
Ongoing and Future Studies
NECVAX-NEO1 is currently under evaluation at additional clinical trial sites in Lithuania, Germany, and Spain, with active patient recruitment ongoing. These studies aim to further explore the potential of this personalized cancer vaccine in treating a variety of solid tumors.
