Vaxon Biotech completes enrollment of phase 2b lung cancer trial of first therapeutic vaccine based on optimized cryptic peptides
- Category: Vaccines
- Published on Thursday, 17 March 2016 09:48
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- Optimized cryptic peptides – essentially ‘universal neo-antigens’ – have the potential to treat tumors across a broad range of patients
- A total of 220 patients enrolled; results due in Q4 2016
PARIS, France I March 16, 2016 I Vaxon Biotech, a biopharmaceutical company developing therapeutic cancer vaccines based on optimized cryptic peptides, today announces the completion of enrollment for its phase 2b 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 tumor peptides.
A total of 220 patients with metastatic NSCLC have now been enrolled in this phase 2b trial across 70 European trial centers. The primary endpoint is to assess the benefit of Vx-001 versus 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 tumors and non-progression of cancer after first line chemotherapy. Over four months, participants received six doses of the Vx-001 vaccine or the placebo, then one dose every three 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 tumor 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-tumor 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 tumors across a broad range of patients, since optimized cryptic peptides are essentially ‘universal neo-antigens’.
“This immuno-oncology trial is one of the biggest of its kind to be carried out 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 3 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.
About Vaxon Biotech
Vaxon Biotech, based in Paris, France, is a biopharmaceutical company developing therapeutic cancer vaccines based on optimized cryptic peptides. Kostas Kosmatopoulos, Vaxon’s founder, invented the proprietary technology for effective cryptic peptide vaccines. Based on Vaxon’s optimized cryptic peptide vaccine platform, the company has developed a pipeline of therapeutic cancer vaccines, led by Vx-001, for which a phase 1/2 trial has been successfully completed, and Vx-006, now in phase 1 of development. Vaxon has received funding support from INSERM, Genopole, OSEO and the French government.
SOURCE: Vaxon Biotech