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ROCKVILLE, Md. - Theriva Biologics (NYSE American: TOVX), a clinical-stage company focused on cancer treatments with a market capitalization of $2.17 million, is set to present data from a Phase 1 study of VCN-01, its investigational therapy for retinoblastoma, at the American Society of Clinical Oncology (ASCO) Annual Meeting in Chicago on Saturday, May 31st, 2025. According to InvestingPro data, the company maintains a stronger cash position than debt, though it’s currently experiencing rapid cash burn.
The study, conducted at Sant Joan de Déu Barcelona Children’s Hospital, assessed the safety and efficacy of VCN-01 in patients with intraocular retinoblastoma that was refractory to other treatments and for whom enucleation, or eye removal, was the only recommended option. The data will be featured in a poster session at the conference.
VCN-01, or zabilugene almadenorepvec, is an oncolytic adenovirus therapy that is designed to target and destroy tumor cells while sparing healthy ones. It has been administered to over 140 patients across various cancers in clinical trials. For retinoblastoma, the therapy has been given intravitreally, directly into the eye.
Steven A. Shallcross, CEO of Theriva Biologics, expressed enthusiasm for the presentation, noting the positive results determined by the Study Monitoring Committee and the opportunity for feedback from the oncology community. The company’s financial health score of 1.5 is rated as ’WEAK’ by InvestingPro, which offers 13 additional investment tips and comprehensive analysis through their Pro Research Report, available for over 1,400 US stocks. Dr. Guillermo Chantada, a key investigator in the trial, highlighted VCN-01’s tolerable toxicity profile and its potential as a non-chemotherapeutic agent, especially for a population at higher risk of treatment-induced malignancies.
In addition to the retinoblastoma study, Theriva’s senior management will attend an off-site meeting during the ASCO conference to discuss the topline results from the VIRAGE Phase 2b clinical trial of VCN-01 in metastatic pancreatic ductal adenocarcinoma (PDAC), with the aim of refining the design for a Phase 3 trial.
Retinoblastoma is a rare eye cancer that primarily affects young children and can be life-threatening if not treated effectively. VCN-01 has received Orphan Drug and Fast Track designations from the FDA for the treatment of pancreatic cancer, as well as Orphan Drug and Rare Pediatric Diseases designations for retinoblastoma. With analysts projecting continued losses this year and a current ratio of 1.53, the company faces significant financial challenges as it advances its clinical programs.
This news is based on a press release statement from Theriva Biologics. The company continues to explore the potential of VCN-01 in treating various forms of cancer, emphasizing the need for new therapies in areas of high unmet medical need.
In other recent news, Theriva Biologics announced the pricing of its public offering, aiming to raise approximately $7.5 million through the sale of shares and warrants. The funds are intended for working capital, general corporate purposes, and potentially future investments or acquisitions, although no agreements are currently in place. A.G.P./Alliance Global Partners is serving as the sole placement agent for this offering. Additionally, Theriva Biologics revealed promising results from its VIRAGE Phase 2b clinical trial, which evaluated the safety and efficacy of VCN-01 in combination with standard chemotherapy for metastatic pancreatic ductal adenocarcinoma. The trial showed improved survival rates and a higher progression-free survival for patients receiving VCN-01. The Independent Data Monitoring Committee confirmed VCN-01’s safety, noting that adverse events were transient and less severe after a second dose. The company is optimistic about these findings, which could support the design of a Phase 3 trial. These developments are part of Theriva Biologics’ ongoing efforts to advance its pipeline of cancer treatments.
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