Shares of Theriva Biologics Inc (NYSE American:TOVX) climbed sharply on Monday after the company disclosed new results from its VIRAGE Phase 2b clinical trial assessing VCN-01 in combination with chemotherapy for patients with metastatic pancreatic cancer.
The data were presented as a poster at the American Association for Cancer Research Annual Meeting in San Diego, with the presentation taking place on Monday. The poster included tumor response information, biomarker findings, and subgroup analyses drawn from the VIRAGE study.
According to the presentation, patients treated with VCN-01 plus gemcitabine/nab-paclitaxel experienced improvements in overall survival and progression-free survival relative to those who received chemotherapy alone. The company reported that the combination produced responses that emerged later, reached greater magnitude, and were more durable than responses observed with chemotherapy by itself.
The reported overall survival advantage for VCN-01 plus chemotherapy was observed consistently across evaluated subgroups, including patients who had liver metastases. The poster also indicated that patients who received a second administration of VCN-01 demonstrated greater benefit in both overall survival and progression-free survival compared with those who did not receive a second administration.
Theriva stated that it has reached alignment with both the U.S. Food and Drug Administration and the European Medicines Agency on a proposed pivotal Phase 3 clinical trial. The planned trial would evaluate multiple doses of VCN-01 in combination with gemcitabine/nab-paclitaxel in first-line metastatic pancreatic cancer patients. The company said it is planning a study to determine whether more frequent and extended dosing of VCN-01 could further enhance outcomes.
In addition to clinical endpoints, the poster presented tumor response and biomarker data that the company interprets as supportive of an immune-mediated mode of action for VCN-01. The late separation of survival curves cited in the presentation is noted as a possible reflection of this immune-mediated mechanism.
Contextual note: The information above is taken from the poster presentation and the company statements associated with it. The material presented included clinical outcome measures, subgroup analyses, and biomarker data as described by the company at the meeting.