Swiss-German biotech company biotech company Vaximm has announced follow-on data from the first clinical trial of its investigational oral T-cell vaccine VXM01.
Data from the trial has shown that VXM01 has a potential to trigger a strong targeted T-cell-mediated immune response in pancreatic cancer patients.
While 45 patients received four doses of VXM01 within a week or placebo, on top of standard-of-care treatment, about 27 additional patients with inoperable pancreatic cancer were later enrolled for the study at the Heidelberg University Hospital in Germany.
Patients were given monthly follow-on vaccinations for up to six month in addition to the previous four-vaccinations-within-a-week schedule as a part of the trial extension.
The study extension observed that about half of the vaccinated patients experienced a drop in their platelet count.
However, after the initial vaccination, two thirds of the patients showed a strong T-cell mediated immune response against the target (VEGFR-2).
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The data also showed that median overall survival in the treatment arm was 10.3 months and the effect was higher in patients with a target specific T-cell response after VXM01 treatment (12.3 months for responders versus 5.4 months for non-responders).
While initial data from VXM01-01-DE have been presented at the 2013 Annual Conference of the American Society of Clinical Oncology, more detailed results will be submitted for presentation at upcoming scientific meetings and for publications in peer-reviewed journals.
One of the principle investigators of the study, Hubertus Schmitz-Winnenthal said: "We are enthusiastic about the high immunological response rate and the improved survival of patients responding to VXM01 treatment.
"This is especially exciting given the patients’ life expectancy and the observed safety profile, even under continued treatment."
Vaximm general manager Heinz Lubenau added: "These are very encouraging data. We are planning to continue the development of VXM01 for the treatment of pancreatic cancer and potentially other solid tumor diseases."