Theriva Biologics announced that the Spanish Agency of Medicines and Medical Devices (AEMPS) has authorized initiation of VIRAGE2, a Phase 2a, single-arm, single-center, open-label proof-of-concept trial to test increased-frequency dosing of VCN-01 (zabilugene almadenorepvec) combined with gemcitabine/nab-paclitaxel in newly diagnosed metastatic pancreatic ductal adenocarcinoma patients.
The study will enroll six evaluable patients at a single site in Spain and is designed to assess the feasibility of administering at least three macrocycles of IV VCN-01 given two months apart alongside standard chemotherapy.
In each macrocycle, VCN-01 is given on day 1 and chemotherapy is administered on days 8, 15, 22, 36, 43 and 50, with macrocycles repeated on days 57 and 113.
Primary endpoints are the adverse event profile and VCN-01 viral genome levels in blood. Secondary endpoints include objective response rate, duration of response, progression-free survival, overall survival and anti-VCN-01 neutralizing antibodies, with exploratory measures of potential viral shedding.
The study is powered at 80% to detect differences in viral genome levels between doses but is not powered for efficacy.
The trial follows VIRAGE Phase 2b findings in which two VCN-01 doses given three months apart were associated with improved survival measures, a finding recognized by the EMA and FDA, according to the company.
Results are intended to inform VCN-01 dosing for a potential pivotal Phase 3 trial. VCN-01 has been administered to 142 patients to date.
