Theriva Biologics is set to present pivotal findings from the VIRAGE Phase 2b clinical trial at the upcoming AACR Annual Meeting in San Diego, highlighting the efficacy of VCN-01 (zabilugene almadenorepvec) in combination with gemcitabine/nab-paclitaxel for patients with newly diagnosed metastatic pancreatic cancer (mPDAC). The trial data, including tumor response and biomarker analyses, indicate a significantly protracted duration of response and improved survival rates in patients treated with VCN-01 compared to those receiving standard chemotherapy alone.

The significance of these findings lies in the immune-mediated mode of action suggested by the results. VCN-01, an oncolytic adenovirus, selectively infects and lyses tumor cells while degrading the tumor stroma, which often acts as an immunosuppressive barrier. This dual action not only enhances the delivery and efficacy of co-administered chemotherapy but also increases the tumor’s immunogenicity, potentially leading to a more robust anti-tumor immune response. The trial’s subgroup analyses further support the treatment’s effectiveness across various patient demographics, including those with liver metastases, a notoriously challenging cohort.

The implications of this research are substantial, as it positions VCN-01 as a promising candidate for pivotal Phase 3 trials, with alignment achieved with both the FDA and EMA for further development. The ongoing exploration of more frequent and extended dosing regimens may optimize patient outcomes even further. This advancement could reshape current therapeutic strategies for mPDAC, emphasizing the integration of oncolytic virotherapy in standard treatment protocols and potentially accelerating drug development timelines in the oncology landscape.

Source: globenewswire.com