Paris, May 19, 2010—Vaxon Biotech, a specialist in tumor immunotherapy, announces 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% of patients. Survival of NSCLC vaccinated with Vx-001 was close to 19 months, at least 50 per cent longer than normal in this patient population...
[...]
...About Vaxon Biotech
Vaxon Biotech is specialized in tumor immunotherapy, a therapeutic approach that consists in stimulating the immune system to target and destroy tumor cells, thus preventing the tumor from progressing. Vaxon Biotech’s innovative and unique vaccine technology (“Optimised Cryptic Peptides”) significantly improves immune response and hence makes vaccines more effective. Vaccines using this technology target cryptic peptides/antigens present on the tumor cell surface. Cryptic peptides do not induce tolerance of the immune system, unlike dominant peptides, which are tolerated by the immune system and therefore generate a weak immune response.Vaxon Biotech’s most advanced product, Vx-001, is slated to enter a pivotal Phase III clinical trial in non-small cell lung cancer (NSCLC) in 2010 with the aim of a marketing authorization in 2014-2015... [PDF] Vaxon Biotech's Press Release -
