Theriva Biologics, a diversified clinical-stage company developing therapeutics designed to treat cancer and related diseases in areas of high unmet need, has dosed its first patient in the phase 2a clinical trial, a small proof-of-concept study evaluating more frequent repeated dosing of VCN-01 (zabilugene almadenorepvec) in first-line metastatic PDAC patients treated with standard-of-care gemcitabine/nab-paclitaxel chemotherapy.
Enrolment into the trial is expected to be completed in H2 2026 and initial pharmacodynamic and safety/tolerability data are anticipated by Q3 2027. Results from this trial will inform the VCN-01 dosing regimen for potential evaluation in a future pivotal phase 3 clinical trial.
The clinical trial is based on observations from the phase 2b clinical trial in metastatic PDAC patients where patients administered two doses of VCN-01 in combination with gemcitabine/nab-paclitaxel SoC chemotherapy exhibited improved overall survival, progression-free survival, and duration of response compared to patients treated with SoC chemotherapy alone.
As previously reported, both EMA scientific advice and FDA meeting feedback recognised the improved survival in the group treated with two doses of VCN-01, and raised the possibility of more frequent, repeated dosing of VCN-01 in combination with SoC chemotherapy to potentially improve clinical outcomes.
