Tokyo, Japan — December 12, 2024, at 10:00 AM JST — NEC Bio Therapeutics has unveiled promising interim results from an ongoing Phase 1 clinical trial of NECVAX-NEO1, an innovative oral cancer vaccine that harnesses artificial intelligence to personalize treatment. These findings were presented at the ESMO Immuno-Oncology Congress in Geneva, Switzerland, which runs from December 11 to 13, 2024.
NECVAX-NEO1 is a cutting-edge, bacteria-based oral DNA vaccine designed specifically to target solid tumors. The vaccine utilizes AI technology to predict the most immunogenic neoepitopes unique to each patient, aiming to stimulate the immune system to generate a robust T-cell response that can effectively identify and destroy tumor cells.
The Phase 1 trial involved five patients diagnosed with melanoma, renal cell carcinoma, or head and neck cancer, all of whom had been undergoing treatment with checkpoint inhibitors (CPI) for a minimum of three months prior to receiving NECVAX-NEO1. During the safety run-in phase of the study, no treatment-related toxicities were observed, which allowed for an increase in dosage.
Results from the trial indicated that 68% of the neoepitopes elicited an ELISPOT response, and 40% of the participants exhibited significant neoantigen-specific signals. Remarkably, after a 24-week treatment period, 80% of the patients maintained a stable disease status, showcasing a high disease control rate.
Dr. Heinz Lubenau, CEO of NEC Bio Therapeutics, expressed enthusiasm regarding the initial proof-of-concept data, stating, “We are very excited about our first proof-of-concept data showing signs of promising immunogenicity and associated biomarker changes in patients. 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.”
Further commenting on the trial’s progress, 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. NECVAX-NEO1 is the first cancer vaccine asset to be clinically developed at NEC. This development ties in with the larger NEC mission of providing healthcare solutions that are innovative and patient-centered.”
The ongoing clinical trial represents a significant step forward in the field of personalized cancer therapy. By leveraging advanced AI technology, NECVAX-NEO1 aims to provide tailored treatment strategies that could improve outcomes for patients facing challenging cancer diagnoses.
As NEC Bio Therapeutics continues to gather data from this trial and future studies, the medical community remains hopeful that NECVAX-NEO1 will pave the way for new avenues in cancer treatment, particularly for those who have exhausted conventional therapies. The integration of AI in vaccine development promises to enhance the precision of immunotherapies, potentially leading to more effective and individualized care for cancer patients.
The ESMO Immuno-Oncology Congress serves as a platform for researchers and clinicians to share the latest advancements in cancer treatment, and NEC Bio Therapeutics’ presentation of NECVAX-NEO1 underscores the growing importance of personalized medicine in oncology.
As the trial progresses, the healthcare community will be closely monitoring the results, with hopes that this innovative approach to cancer vaccination will contribute significantly to the future of cancer treatment.
