Theriva Biologics Inc（TOVX）のニュースとイベントTOVXTheriva Biologics Inc

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.