By C. Rajan, contributing writer
Swiss biotech firm, Vaximm AG, has announced the positive follow-on data from the first clinical trial of its novel oral T-cell vaccine, VXM01 in pancreatic cancer patients. The data from a trial extension of the Phase 1 study indicate that VXM01 triggers a strong T-cell-mediated immune response in patients.
This first Phase 1 clinical study (VXM01-01-DE) was designed to test the safety and tolerability of VXM01 in a total of 72 patients with inoperable pancreatic cancer at the Heidelberg University Hospital (Heidelberg, Germany). The trial was a randomized, double-blind, placebo-controlled, dose escalation study, which had secondary endpoints of immunological response, clinical responses, and overall survival. The patients received either the vaccine or a placebo, along with the standard-of-care, gemcitabine.
The study was divided in two parts. In the first study part, 45 patients were treated with four vaccinations, which were administered within a week. The positive results from this first part were reported by Vaximm last year. All the patients showed a strongly increased T-cell mediated immune response against the VEGFR-2 target.
In the second part of the study — the trial extension which has produced the latest data — an additional 27 patients in the treatment arm received booster shots of monthly follow-on vaccinations for up to six months.
The study extension confirmed the results from the first part regarding safety and secondary endpoints. Furthermore, two thirds of the trial patients showed a strong T-cell mediated immune response against the VEGFR-2 target.
Median overall survival was 12.3 months in patients with a target specific T-cell response after VXM01 treatment versus 5.4 months for patients who did not show this response. The company said that more detailed study results will be published in peer-reviewed journals.
“These are very encouraging data,” said Dr. Heinz Lubenau, GM of Vaximm GmbH. “We are planning to continue the development of VXM01 for the treatment of pancreatic cancer and potentially other solid tumor diseases.”
VXM01 is an oral VEGFR-2 directed T-cell vaccine that targets the tumor vasculature. VXM01 is designed to stimulate the patients' own immune system to destroy tumor-associated blood vessels, which are essential for the growth of tumors, rather than targeting the cancer cells directly as other immunotherapy vaccines do. VXM01 is also the first therapeutic oral cancer vaccine which acts in the gut to induce the immune system’s cancer-fighting response.