ROCKVILLE, Md. - Theriva Biologics (NYSE American: TOVX), a clinical-stage biopharmaceutical company, has received Fast Track Designation (FTD) from the U.S. Food and Drug Administration for its leading clinical candidate VCN-01. This designation is specifically for the treatment of metastatic pancreatic adenocarcinoma in combination with chemotherapy drugs gemcitabine and nab-paclitaxel.
The FTD aims to expedite the development and review of drugs that treat serious conditions and fulfill an unmet medical need. Theriva's VCN-01 is currently being evaluated in a Phase 2b trial named VIRAGE, which is expected to complete patient enrollment by the third quarter of 2024.
The trial investigates the efficacy of VCN-01 as a first-line therapy for patients with pancreatic ductal adenocarcinoma (PDAC), a cancer type that represents over 90% of all pancreatic tumors and is a leading cause of cancer-related deaths.
Steven A. Shallcross, Chief Executive Officer of Theriva Biologics, highlighted the urgency for new treatments for PDAC and expressed the company's commitment to advancing therapeutic options for patients. The FDA's FTD to VCN-01 underscores the potential of the drug, which is designed to selectively target and destroy tumor cells, enhance the efficacy of co-administered chemotherapy, and increase tumor immunogenicity.
VCN-01's approach involves a systemically administered oncolytic adenovirus that replicates within tumor cells and degrades the tumor stroma, which can be a barrier to effective cancer treatment. The drug has been administered to over 80 patients across various cancers in both Phase 1 and investigator-sponsored clinical trials.
Theriva Biologics continues to develop a portfolio of therapeutics aimed at treating cancer and related diseases, with a focus on areas of high unmet need. The company's pipeline also includes SYN-004 and SYN-020, targeting different aspects of cancer treatment and patient care.
This news is based on a press release statement from Theriva Biologics and does not include any editorial commentary or speculation about the broader implications of the FDA's decision.
InvestingPro Insights
As Theriva Biologics (NYSE American: TOVX) forges ahead with its clinical trials, investors and stakeholders are keeping a close watch on the company's financial health and market performance. Recent data from InvestingPro shows a market capitalization of $6.25 million for Theriva Biologics, indicating the size of the company in the competitive biopharmaceutical landscape.
Analysis of the company's financial metrics reveals a concerning P/E ratio, standing at -0.33 for the last twelve months as of Q1 2024. This negative figure reflects challenges in profitability, aligning with the InvestingPro Tips that indicate Theriva Biologics is not expected to be profitable this year and has been struggling with weak gross profit margins.
Moreover, the company's price performance has been underwhelming, with a 1-year price total return of -47.54%, underscoring the importance of strategic decisions and successful trial outcomes for future growth.
Despite these challenges, Theriva Biologics holds a silver lining with more cash than debt on its balance sheet, as per InvestingPro Tips. This financial stability is crucial for the company as it navigates the costly process of drug development and clinical trials. Furthermore, liquid assets exceed short-term obligations, providing some buffer against immediate financial pressures.
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