Vaxon Biotech, a biopharmaceutical company developing therapeutic cancer vaccines based on optimized cryptic peptides, has announced the completion of enrolment for its Phase IIb trial of Vx-001 in non-small-cell lung cancer (NSCLC). Vx-001 is a therapeutic cancer vaccine based on proprietary antigens known as optimized cryptic tumour peptides.
A total of 220 patients with metastatic NSCLC have now been enrolled in this Phase IIb trial across 70 European trial centres. The primary endpoint is to assess the benefit of Vx-001 versus a placebo on overall survival. Final trial results are expected in the fourth quarter of 2016.
An average of one in six patients were selected after meeting three criteria: expression of HLA-A2, TERT-expressing tumours and non-progression of cancer after first line chemotherapy. During a period of 4 months, participants received six doses of the Vx-001 vaccine or the placebo, then one dose every 3 months.
Vx-001 is the first vaccine to use optimized cryptic peptides and is the only such vaccine in development. Optimized cryptic peptides are universal tumour peptides that, while normally undetected by the immune system, have been modified to optimize their presentation to the immune system so as to induce a powerful anti-tumour immune response.
Vaxon’s optimized cryptic peptides, like neo-antigen vaccines, avoid the problem of immune tolerance and are strongly immunogenic. Unlike neo-antigen vaccines, Vaxon’s optimized cryptic peptides need not be individualized; instead, they have the potential to treat tumours across a broad range of patients, as optimized cryptic peptides are essentially ‘universal net-antigens.’
“This immuno-oncology trial is one of the biggest of its kind to be done by a small biotech company,” said Kostas Kosmatopoulos, Vaxon’s CEO and founder. “Finalizing the study has been extremely satisfying for Vaxon Biotech as it has surpassed many of the expectations for a company of our size. It is a strong sign for the market.”
If the results are positive, a large Phase III study for the same indication will be launched across the European Union and in the United States in 2017. Vaxon Biotech is aiming to receive marketing authorization in 2020.