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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) announced the initiation of its Phase 2b trial, VIRAGE, for the treatment of newly-diagnosed metastatic pancreatic ductal adenocarcinoma (PDAC). The first patient has been dosed in Spain, with a total enrollment of 92 adults planned across the US, Spain, and Germany. The trial will evaluate the safety and efficacy of VCN-01 combined with standard chemotherapy (gemcitabine/nab-paclitaxel). Primary endpoints include overall survival and safety, with additional metrics assessing progression-free survival and immune response. This trial represents a vital step towards improving treatment for patients with high unmet needs in oncology.
Theriva Biologics (NYSE American: TOVX) announced the dosing of the first patient in a Phase 1 clinical trial of VCN-01, an oncolytic adenovirus, targeted at treating high-grade brain tumors. Conducted at St. James’s University Hospital in collaboration with the University of Leeds, this trial aims to assess the safety and effectiveness of VCN-01 in patients scheduled for surgical resection. Successful results could significantly improve treatment options for patients with challenging brain tumors, reducing the need for invasive surgeries.
Theriva Biologics (NYSE American: TOVX) has announced participation in two investor conferences in December 2022. The first is the Alliance Global Partners Virtual Series on December 7, featuring a fireside chat and one-on-one meetings at 11:00 AM ET. The second is the Sidoti Virtual Conference on December 8, offering a corporate update at 9:15 AM ET. Webcasts for both events can be accessed via the company’s website. Theriva focuses on developing therapeutics for cancer and related diseases, utilizing innovative platforms including oncolytic adenoviruses.
Theriva Biologics (TOVX) announced positive clinical data and received FDA clearance for its Phase 2 trial of VCN-01 for pancreatic cancer. In Q3 2022, its cash reserves stood at $50.5 million, expected to fund operations into Q1 2024. The company also reported a 30% increase in R&D expenses to $2.6 million, linked to VCN-01 initiatives. Additionally, SYN-004 (ribaxamase) showed promising safety data, with patient enrollment in Cohort 2 commenced. A conference call is scheduled for November 11 to discuss these updates and financial results.
Theriva Biologics (NYSE American: TOVX) has rescheduled its conference call to November 11, 2022, at 8:30 a.m. ET to discuss Q3 2022 financial results and corporate updates. The original date was set for November 10. Participants can join via phone or access the call through the company's website. Theriva is focused on developing therapeutics for cancer treatment, with key products including VCN-01, SYN-004, and SYN-020, aimed at improving patient outcomes in high unmet need areas.
Theriva Biologics (TOVX) will host a conference call on November 10, 2022, at 8:30 a.m. ET, to discuss its financial results for Q3 2022, ending September 30. The call will provide a corporate update, with live participation available via phone or online. The company specializes in developing therapeutics for cancer and related diseases, including innovative treatments like VCN-01, SYN-004, and SYN-020. For further details, visit their website.
Theriva Biologics (TOVX) announced the dosing of the first patient in Cohort 2 of its ongoing Phase 1b/2a clinical trial for SYN-004, aimed at preventing acute graft-versus-host disease (aGVHD) in allogeneic hematopoietic cell transplant (HCT) recipients. Following a positive safety review of Cohort 1 by an independent committee, the trial will assess SYN-004’s safety and pharmacokinetics while evaluating its protective effects on the gut microbiome. The trial is expected to enroll up to 36 participants, advancing therapeutic options for patients with hematologic cancers.
Theriva Biologics (NYSE American: TOVX) announced a KOL webinar on November 7, 2022, at 11 a.m. ET, featuring experts Michael Aaron Morse, M.D., and Arsen Osipov, M.D. The discussion will focus on the oncolytic virus landscape and data supporting the Company’s novel oncolytic adenovirus platform for treating cancers with high unmet needs, specifically pancreatic ductal adenocarcinoma (PDAC). The upcoming Phase 2 trial, VIRAGE, will evaluate VCN-01 combined with standard chemotherapy. A live Q&A will follow the presentation.
Theriva Biologics (TOVX) announced an oral presentation highlighting the encouraging biological activity of VCN-01 in combination with durvalumab at the 14th International Oncolytic Virotherapy Conference in Japan. The Phase 1 study focuses on patients with recurrent/metastatic squamous cell carcinoma of the head and neck (R/M HNSCC). The presentation, scheduled for October 25, 2022, will be delivered by COO Frank Tufaro. This research may support further development of VCN-01 as a viable treatment option in oncology.
Theriva Biologics, formerly known as Synthetic Biologics, Inc. (NYSE American: TOVX), announced a rebranding to reflect its focus on developing innovative oncolytic viruses for cancer treatment. The new branding will be visible with the stock trading under the ticker symbol TOVX starting October 13, 2022. The company highlighted its lead clinical program, VCN-01, aimed at improving tumor treatment, alongside the preclinical program VCN-11. Theriva aims to significantly impact patients with high unmet needs through its advanced therapies, reinforcing its commitment to addressing challenging cancers.
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