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Theriva Biologics Publishes VCN-01 Trial Results
Theriva Biologics announced that detailed analysis of results from the VIRAGE Phase 2b clinical trial of VCN-01 in metastatic pancreatic cancer patients were published in Nature Medicine. The article, entitled "Intravenous hyaluronidase-expressing oncolytic adenovirus with chemotherapy in metastatic pancreatic cancer: a randomized phase 2b trial." Key highlights: Publication in this premier journal after rigorous peer review validates the VIRAGE study and supports the continued evaluation of VCN-01 in the treatment of metastatic pancreatic cancer; Data are consistent with an immune mediated mechanism of action for VCN-01 that may enhance the antitumor effects of a range of coadministered pancreatic cancer therapies; The feasibility of administering more frequent repeated VCN-01 doses to potentially improve clinical outcomes in metastatic pancreatic cancer patients is currently being evaluated in the VIRAGE2 Phase 2a clinical trial
Theriva Biologics Receives AEMPS Approval to Initiate VIRAGE2 Clinical Trial
Theriva Biologics announced that the Spanish Agency of Medicines and Medical Devices, or AEMPS, has authorized the company to initiate the VIRAGE2 clinical trial, entitled "A Phase IIa, single-arm, single-center, open-label, proof-of-concept trial evaluating increased frequency dosing of zabilugene almadenorepvec in combination with gemcitabine/nab-paclitaxel in patients with newly-diagnosed metastatic pancreatic cancer".
Theriva Biologics to Present New VCN-01 Data at AACR Meeting
Theriva Biologics "announced an upcoming poster presentation of new data and subgroup analyses from the VIRAGE Phase 2b clinical trial evaluating VCN-01 (zabilugene almadenorepvec) plus gemcitabine/nab-paclitaxel in newly-diagnosed metastatic pancreatic cancer patients. Tumor reponse, biomarker data, and subgroup analyses are to be presented at the American Association for Cancer Research (AACR) Annual Meeting to be held in San Diego, CA from 17-22 April 2026." "The new data and analyses to be presented at the AACR meeting further reinforce our confidence in the clinical potential of VCN-01 plus gemcitabine/nab-paclitaxel chemotherapy to help metastatic PDAC patients," said Steven A. Shallcross, Chief Executive Officer of Theriva Biologics. "Taken together, the tumor response and biomarker data support an immune-mediated mode of action for VCN-01, which is consistent with the previously reported clinical observations, showing that patients treated with VCN-01 plus gemcitabine/nab-paclitaxel experienced a significantly protracted duration of response concomitant with a later-stage prolongation of survival compared to patients treated with gemcitabine/nab-paclitaxel alone. We have achieved alignment with both the FDA and the EMA on a proposed pivotal Phase 3 clinical trial to evaluate multiple doses of VCN-01 plus gemcitabine/nab-paclitaxel in first-line metastatic PDAC patients, and we are planning a small study to assess whether more frequent and extended VCN-01 dosing could further improve outcomes."
Theriva Biologics Reaches Agreement with FDA on VCN-01 Phase 3 Trial Design
Theriva Biologics announced the outcomes of a recent Type B End-of-Phase 2 meeting with the FDA regarding the design of a Phase 3 clinical study of lead clinical candidate VCN-01 in combination with standard-of-care chemotherapy for the treatment of metastatic pancreatic adenocarcinoma. The FDA provided general agreement with Theriva's proposed design for a Phase 3 clinical trial, which closely tracks the design of the successful VIRAGE Phase 2 trial. As announced in 2025, the VIRAGE trial met its primary endpoints, with metastatic PDAC patients receiving VCN-01 with SoC chemotherapy having improved overall survival, progression free survival and Duration of Response compared to SoC chemotherapy alone. Greater improvements in OS and PFS were observed in patients who received two doses of VCN-01, leading Theriva to plan the Phase 3 trial to include repeat dosing and an adaptive design aimed to optimize the trial's timelines and outcomes. Consistent with scientific advice previously received from the Committee for Medicinal Products for Human Use of the European Medicines Agency, the FDA advised that a potential biologics licensing application for VCN-01 in metastatic PDAC could be supported by Theriva's proposed Phase 3 clinical trial comprising a single, high-quality, randomized, double-blinded, study comparing VCN-01 plus gemcitabine/nab-paclitaxel SoC to gemcitabine/nab-paclitaxel SoC plus placebo. The FDA further agreed on the proposed dosing of VCN-01 and gemcitabine/nab-paclitaxel in repeated "macrocycles", the proposed inclusion/exclusion criteria, the primary endpoint (overall survival), key secondary endpoints, and the use of an adaptive design. The FDA also clarified statistical expectations regarding the proposed interim analyses and the quality of data required for potential sample size re-estimation or a demonstration of early efficacy.
SYN-020 Licensed to Rasayana Therapeutics, Advancing Oncology Drug Development
"We are very pleased to have completed the licensing of our versatile Phase 2-ready asset SYN-020 to Rasayana Therapeutics, executing on our plan to derive value from our GI portfolio while we remain focused on the advancement of our oncology pipeline," said Steven A. Shallcross, CEO. "We continue to advance our lead oncolytic virus candidate VCN-01 towards pivotal clinical development in multiple indications of high unmet need. With the recent feedback from the EMA, we have further clarity on dosing regimen, protocol and overall design for our proposed Phase 3 trial in pancreatic ductal adenocarcinoma. An End-of-Phase 2 meeting with the FDA is planned for the first half of 2026 to finalize our design for a multinational pivotal Phase 3 trial in PDAC, aiming to provide patients with a novel therapy for this difficult to treat solid tumor that has a high mortality rate. Additional interactions with the FDA and EMA are planned for 2026 to refine the design of a potential Phase 2/3 trial for retinoblastoma, for which VCN-01 has received Orphan Drug and Rare Pediatric Disease designation. We continue to engage in potential partnership discussions for the additional innovative drug candidates in our portfolio."
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