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ROCKVILLE, Md. - Theriva Biologics (NYSE American: TOVX), a clinical-stage biopharmaceutical company with a market capitalization of $3.17 million, announced today that its VIRAGE Phase 2b clinical trial for the treatment of metastatic pancreatic ductal adenocarcinoma (PDAC) has yielded positive safety data for its therapeutic candidate VCN-01. The Independent Data Monitoring Committee (IDMC) found VCN-01 to be well tolerated in combination with standard chemotherapy. According to InvestingPro data, the company maintains a healthy current ratio of 2.15, indicating strong short-term liquidity to support its clinical programs.
The IDMC, comprised of experts in pancreatic cancer and oncolytic viruses, reviewed safety data from 101 patients across sites in the United States and Spain. The adverse events associated with VCN-01 were consistent with those from previous trials and were transient and reversible. Notably, these events were less frequent and less severe following the second dose of the treatment.
VCN-01 is an oncolytic adenovirus designed to target and destroy tumor cells while also breaking down the tumor stroma, which often acts as a barrier to treatment. The VIRAGE trial, which completed patient enrollment in September 2024, is evaluating the efficacy of VCN-01 in combination with the chemotherapy agents gemcitabine and nab-paclitaxel. Topline clinical outcomes from the trial are expected in the second quarter of 2025.
While the stock has experienced a significant decline of over 90% in the past year, Steven A. Shallcross, CEO of Theriva Biologics, expressed confidence in the repeated dosing of VCN-01 for metastatic PDAC patients. The company anticipates that the forthcoming clinical data, along with previous feedback from the FDA and EMA, will inform the design of a potential Phase 3 registrational trial. InvestingPro analysis suggests the stock is currently undervalued, with additional insights available in the comprehensive Pro Research Report, which covers over 1,400 US stocks.
The VIRAGE trial’s primary endpoints include overall survival and safety/tolerability of VCN-01. Additional endpoints being assessed are progression-free survival, objective response rate, and measures of VCN-01 biodistribution, replication, and immune response.
Theriva Biologics is developing a portfolio of treatments targeting cancer and related diseases with significant unmet medical needs. Their lead candidates include VCN-01 and other therapeutics aimed at enhancing the efficacy of cancer treatments and improving patient outcomes.
This report is based on a press release statement from Theriva Biologics, Inc.
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