Date: 2016-03-16
Type of information: Completion of patient enrollment
phase: 2b
Announcement: completion of patient enrollment
Company: Vaxon Biotech (France)
Product: Vx-001
Action
mechanism: peptide/immunotherapy product. Vx-001 is the most advanced product in the Vaxon Biotech portfolio. It is a peptide-based vaccine for HLA-A2-positive patients with TERT-expressing tumors. Vx-001 is composed of two peptides that are administrated separately: the native cryptic peptide ARG-Vx001 and its optimized variant TYR-Vx001 that is strongly immunogenic. Vx-001 can treat almost all tumors, irrespective of their histological origin. The antigen target (Telomerase reverse transcriptase, TERT) is a universal tumor antigen expressed by more than 85% of tumors. Eight patents have been granted in the US, Europe, Japan, China and Canada to cover Vx-001. The EMA granted Vx-001 orphan medicinal product designation for its first indication (NSCLC) in 2007, with the FDA doing likewise in 2009. 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’.
Disease: non-small-cell lung cancer
Therapeutic area: Cancer - Oncology
Country: Czech Republic, France, Germany, Greece, Italy, Poland, Romania, Spain
Trial details:
Latest
news: * On March 16, 2016, Vaxon Biotech, a biopharmaceutical company developing therapeutic cancer vaccines based on optimized cryptic peptides, announced the completion of enrollment for its phase 2b trial of Vx-001 in non-small-cell lung cancer (NSCLC). 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 * On December 1, 2014, Vaxon Biotech announced the recruitment of the 110th patient in its multicenter phase IIB study of the Vx-001 vaccine in non-small-cell lung cancer (NSCLC). The 110th patient was randomized in October. A total of 220 patients will be randomized in 65 sites across Italy, Spain, Germany, Greece, Poland, France, Romania and the Czech Republic. The Vx-001-201 trial is applicable to patients with metastatic NSCLC who do not progress after platinum based first line chemotherapy. The results of the Vx-001-201 trial are expected in Q4 2016.
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.
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.
