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- 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…
– First patients dosed in the VIRAGE2 Phase 2a clinical study evaluating more frequent repeated dosing of VCN-01 (zabilugene almadenorepvec) the goal of which is to improve treatment outcomes in metastatic pancreatic ductal adenocarcinoma (PDAC) patients – – Cash and cash equivalents of $11.3 million as of June 30, 2026; cash runway into Q1 2027 – ROCKVILLE, Md., Aug.
- VIRAGE2 exploratory study designed to refine the VCN-01 dosing regimen for potential evaluation in a future pivotal Phase 3 clinical trial in metastatic pancreatic ductal adenocarcinoma (PDAC) - - Study builds on positive clinical data from the VIRAGE Phase 2b study and feedback from the European Medicines Agency (EMA) and the U.S.
- VIRAGE2 exploratory study designed to refine dosing regimen to potentially improved outcomes in a future pivotal Phase 3 clinical trial - - Study builds on positive clinical data from the recent VIRAGE study and feedback from the EMA and FDA recognizing the…
– Prolonged overall survival (OS) was observed in heavily pre-treated refractory Head & Neck Squamous Cell Carcinoma (HNSCC) patients administered IV VCN-01 prior to the immune checkpoint inhibitor durvalumab – – Pharmacokinetic, tissue biopsy, radiomic and…
– Alignment with the FDA on the Phase 3 trial design of VCN-01 (zabilugene almadenorepvec) for treatment of metastatic pancreatic ductal adenocarcinoma (PDAC) – – Additional data from VIRAGE Phase 2b clinical trial of VCN-01 in metastatic PDAC patients…
- Tumor reponse, biomarker, and subgroup analyses from the VIRAGE Phase 2b clinical trial support a VCN-01 immune-mediated mode of action and demonstrate improved outcomes in VCN-01 treated patients across multiple subgroups, including patients with liver…
– Successful meeting with FDA enables advancement into proposed Phase 3 clinical trial of VCN-01 in combination with gemcitabine/nab-paclitaxel for the first-line treatment of metastatic PDAC – – Combined feedback from FDA and previously from EMA enables…
- Advancing clinical development of VCN-01 for pancreatic ductal adenocarcinoma and retinoblastoma - - Licensed SYN-020 to Rasayana Therapeutics for development in multiple indications; up to $38 million in potential milestones plus royalties on commercial…
- Theriva received a $300,000 upfront payment at signing and is eligible for up to $38M in development, regulatory, and sales milestones along with tiered single-digit royalties on net product sales - - Rasayana to assume all responsibility and costs for…
- Safety and clinical outcomes of Phase 1 study of VCN-01 (zabilugene almadenorepvec) in refractory retinoblastoma patients to be presented in an invited session at the 41st Asia-Pacific Academy of Ophthalmology (APAO) Congress in Hong Kong on Saturday, 07…
Theriva Biologics (TOVX) announced the receipt of Scientific Advice from the Committee for Medicinal Products for Human Use of the European Medicines Agency on the design of a Phase 3 clinical trial of lead clinical candidate VCN-01 in combination with…