The Theriva Biologics Inc (NYSEAMERICAN: TOVX) stock price soared 61.9% after the United States Food and Drug Administration (FDA) granted its lead clinical candidate VCN-01 orphan drug designation. VCN-01 is a drug treatment for pancreatic cancer.
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The company has an ongoing multinational Phase 2b clinical study known as VIRAGE, where VCN-01 is being evaluated in combination with standard-of-care (SoC) chemotherapy (gemcitabine/nab-paclitaxel) as a first-line therapy for patients with pancreatic ductal adenocarcinoma (PDAC).
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The FDA has previously granted VCN-01 orphan drug status as a treatment for retinoblastoma. VCN-01 is a systemic, selective, stroma-degrading oncolytic adenovirus that can treat pancreatic cancer and other similar ailments, such as retinoblastoma.
Theriva Biologics is a clinical-stage company developing therapeutics designed to treat cancer and related diseases in areas of high unmet need. The orphan drug designation is granted selectively to drugs developed to treat, diagnose, or prevent a rare disease or condition affecting fewer than 200,000 people in the United States.
The orphan drug designation provides drug developers multiple benefits to develop novel drugs, including potential market exclusivity for seven years after the FDA approves the drug and tax credits eligible for qualified clinical trials.
Drug developers can also get application fee waivers, lower annual product fees, assistance with clinical protocols and qualification for expedited development programs.
Steven A. Shallcross, Theriva Biologics’ CEO, said: “The FDA’s decision to grant orphan drug designation to VCN-01 highlights the urgent need for new treatment options for patients with PDAC, which has one of the lowest survival rates among all cancers,”
“Efforts to improve upon the standard of care treatment have largely stalled, despite the growing incidence of PDAC, and the need for novel therapies in this indication is acute. The growing clinical data that underscore VCN-01’s multiple modes of action and the compelling clinical outcomes observed in Phase 1 studies of VCN-01 in combination with chemotherapy or immunotherapy in patients with PDAC and other solid tumors, give us confidence that VCN-01 has the potential to address this unmet medical need.”
*This is not investment advice.
Theriva Biologics (TOVX) stock price.
The Theriva Biologics (TOVX) stock price soared 61.91% to trade at $1.3400, from Tuesday’s closing price of $0.8276
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