Vaxon Biotech successfully completes its Phase I/II trial of Vx-001 cancer vaccine
Phase III ready to start in NSCLC
Vaxon Biotech announced the successful conclusion of the Phase I/II trial of its Vx-001 therapeutic cancer vaccine. As a result, Vaxon is pursuing the clinical development of Vx-001 by launching a pivotal phase III trial in non-small cell lung cancer (NSCLC) in 2010, and in hepatocellular carcinoma and breast cancer in 2012-2013.
The phase I/II trial was conducted among 116 patients with different types of cancer including 33 patients with NSCLC. The primary objective was to evaluate safety of Vx-001, with a secondary objective to evaluate immune response and clinical response. Results showed that Vx-001 is safe (only grade I vaccine related toxicity was observed) and well tolerated by the patients, that it induces a long lasting vaccine specific immune response in 70 percent of patients, and that it has a significant clinical activity: four patients experienced objective response and 33 patients stabilized their disease for more than six months. Survival of vaccinated patients was related to the immune response; patients who developed immune response had a longer survival than patients who failed to do so. Analysis focused on the thirty-three NSCLC showed that Vx-001 induces long lasting disease control, including objective responses, in more than 42 percent of patients. Survival of NSCLC vaccinated with Vx-001 was close to 19 months, at least 50 percent longer than normal in this patient population.
On the basis of this successful phase I/II trial and the very promising results in NSCLC, the European Medicines Agency (EMA) has approved the design of the planned pivotal phase III study and agreed to consider Vx-001 for marketing authorization after the completion of this trial.
“We are delighted that Vaxon will become of the select few biotech companies to have a product in a late stage of clinical development,” said Kostas Kosmatopoulos, CSO of Vaxon Biotech. “If all goes to plan, Vx-001 will be the first vaccine to enter the market for patients with advanced locoregional and metastatic NSCLCs that account for 50 percent of all lung cancers. It will also be one of the first immunotherapeutic anti-cancer products on the market, thus confirming the high potential of this innovative solution.”
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