Positive topline results from study of VXM01 (Vaximm) for Pancreatic Cancer

Topline data from a randomized, placebo-controlled, double-blind Phase I/II dose escalation study of vaccine VXM01, from Vaximm, shows the treatment met all key endpoints and demonstrated safety and tolerability in patients with Pancreatic Cancer. In this study (VXM01-01-DE), 45 patients with inoperable pancreatic cancer received several doses of VXM01 in addition to standard-of-care treatment, or placebo. Results indicate that the vaccine was safe and well tolerated. No dose-limiting toxicities were observed. Besides this primary endpoint, several important secondary endpoints, including specific T-cell response and changes in tumor perfusion, were met. After vaccination, a quarter of the patients showed a strongly increased T-cell mediated immune response against the target (VEGFR-2), which was distinct from fluctuations observed in the placebo-treated patients.

Immunologically responding patients occurred already in the lowest dose group. A third of the VXM01-treated patients had a strong drop in tumor perfusion following the treatment, accompanied by corresponding changes in tumor-specific and angiogenesis-related biomarkers. Tumor perfusion changes in the treatment group were correlated with the VEGFR-2 specific effector and regulatory T-cell responses. Detailed results will be submitted for presentation at upcoming meetings and for publication.