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Theriva Biologics, Inc. (NYSE American: TOVX) is a clinical-stage pharmaceutical company dedicated to developing innovative therapeutics to combat cancer and related diseases. The company's main focus is on its novel oncolytic adenovirus (OV) platform, which seeks to address devastating cancers that have high unmet medical needs.
Key Programs and Lead Candidates
- VCN-01: The company's flagship clinical-stage program, VCN-01, is designed to selectively infect and break down the tumor stroma, enhancing the efficacy of co-administered cancer therapies and promoting an anti-tumor immune response. VCN-01 has shown promising results in Phase 1 trials and is currently being evaluated in a Phase 2b trial known as VIRAGE. This trial aims to enroll up to 92 patients with metastatic pancreatic ductal adenocarcinoma (PDAC) across sites in the US and Spain.
- VCN-11: A preclinical-stage program that utilizes the company's proprietary Albumin Shield Technology to protect oncolytic viruses from the host immune system, potentially allowing for more effective systemic administration.
- SYN-004 (ribaxamase): Designed to protect the gut microbiome from the harmful effects of intravenous beta-lactam antibiotics, this therapeutic aims to prevent conditions like C. difficile infection (CDI), antibiotic-associated diarrhea (AAD), and the emergence of antimicrobial resistance (AMR).
- SYN-020: A recombinant oral formulation of intestinal alkaline phosphatase (IAP), intended to treat both local gastrointestinal and systemic diseases.
Financial and Business Updates
Theriva Biologics recently reported a 28% decrease in general and administrative expenses for the year ended December 31, 2023. This was primarily due to lower salary, investor relations, legal costs, and other expenses. Research and development expenses increased by 22% to $14.3 million, driven by higher clinical trial costs related to the VIRAGE study.
Partnerships and Achievements
Theriva Biologics collaborates with various research institutions and clinical centers across the US and Spain. The Independent Data Monitoring Committee (IDMC) recently recommended the continuation of the VIRAGE trial without any changes to the protocol, marking a significant milestone for the company's lead program.
Future Prospects
Theriva Biologics is well-positioned to advance its clinical programs and achieve several important milestones. The company expects to complete enrollment for the VIRAGE trial by the first half of 2024 and is also focusing on expanding its VCN-01 program to include combinations with other chemotherapeutic regimens.
Theriva™ Biologics (NYSE American: TOVX) has received Rare Pediatric Drug Designation (RPDD) from the U.S. FDA for VCN-01 in treating retinoblastoma. VCN-01, Theriva's lead candidate, is a systemic, selective, stroma-degrading oncolytic adenovirus. This follows a previous orphan drug designation for the same indication.
The designation highlights the urgent need for new treatments for pediatric retinoblastoma patients. Theriva is working with physicians and regulators to refine its clinical strategy for VCN-01 as an adjunct to chemotherapy. Recent Phase 1 trial results for intravitreal VCN-01 in refractory retinoblastoma were deemed positive by the study Monitoring Committee.
If VCN-01 receives FDA approval for retinoblastoma, Theriva may be eligible for a Priority Review Voucher, which can be used or sold.
Theriva Biologics (NYSE American: TOVX) announced that the U.S. FDA granted Fast Track Designation (FTD) to its clinical candidate VCN-01 for treating metastatic pancreatic cancer. This designation aims to expedite the drug's development and review process. VCN-01, combined with gemcitabine and nab-paclitaxel, is undergoing a Phase 2b clinical study (VIRAGE) to evaluate its effectiveness as a first-line therapy for pancreatic ductal adenocarcinoma (PDAC). The FDA had previously given orphan drug status to VCN-01 for PDAC. The ongoing VIRAGE trial is expected to complete enrollment by Q3 2024. FTD allows for early and frequent FDA interactions and could speed up the approval process if certain criteria are met.
Theriva Biologics (NYSE American: TOVX) announced its participation in the A.G.P. 2024 Virtual Healthcare Conference. The event is scheduled for May 21, 2024, at 7:30 AM ET. The company's management will provide a corporate update and participate in a fireside chat. Theriva Biologics, a clinical-stage company, focuses on developing therapeutics for cancer and related diseases. The presentation will be available via webcast.
Theriva™ Biologics, a clinical-stage company, reported positive results from a Phase 1 trial for VCN-01 in pediatric patients with retinoblastoma and presented preclinical data on VCN-01's potential in pancreatic cancer treatment. The Phase 2b trial for VCN-01 in metastatic Pancreatic Ductal Adenocarcinoma (PDAC) is expected to complete enrollment soon. The company has $18.3 million in cash as of March 31, 2024, providing runway into Q1 2025.
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