ROCKVILLE, Md. - Theriva Biologics (NYSE American: TOVX), a biopharmaceutical company focused on cancer therapies, has announced positive outcomes from a Phase 1 trial in collaboration with Sant Joan de Déu-Barcelona Children’s Hospital (SJD) for its investigational drug VCN-01, aimed at treating retinoblastoma, a rare pediatric eye cancer.
The study, which involved nine patients with retinoblastoma that was unresponsive to other treatments, tested the safety and tolerability of two intravitreal injections of VCN-01. The Monitoring Committee overseeing the trial has deemed the results positive, paving the way for Theriva Biologics to obtain an exclusive, worldwide license and related patents from SJD for the treatment of advanced retinoblastoma in children.
VCN-01, an oncolytic adenovirus, is designed to selectively target and destroy tumor cells while leaving healthy cells unharmed. In this trial, patients received two injections of the drug, 14 days apart. The most commonly reported side effects were mild, and there were no severe ocular or systemic toxicities. Some patients experienced ocular inflammation, which was managed with anti-inflammatory drugs.
The trial's results are encouraging for Theriva Biologics as they plan to move forward with a Phase 2 clinical trial. The drug demonstrated promising antitumor activity and did not impair retinal function. Notably, eye enucleation, the surgical removal of the eye, was avoided in three patients, with one retaining their eye four years post-treatment.
Retinoblastoma typically affects children under the age of six and poses significant treatment challenges, including the risk of eye loss and reduced quality of life. The disease is the most common eye cancer in children, with an incidence rate of approximately 3.3 per 1,000,000 in the U.S., translating to 200-300 diagnoses annually.
The data from this trial contribute to the understanding of VCN-01's mechanism of action and its potential to improve outcomes in refractory cancers. Theriva Biologics continues to develop its pipeline of cancer therapeutics, including VCN-01, with the aim of addressing high unmet medical needs.
This report is based on a press release statement from Theriva Biologics, Inc.
InvestingPro Insights
As Theriva Biologics (NYSE American: TOVX) continues to make strides in the development of its cancer therapies, the financial metrics of the company provide a broader context for investors. With a market capitalization of just 7.05 million USD, Theriva operates on a smaller scale compared to some of its industry peers.
This is reflected in the company's performance metrics over the last twelve months, including a Price / Book ratio of 0.19, which suggests that the market values the company at less than its book value, potentially indicating undervaluation or inherent risks.
An InvestingPro Tip for Theriva Biologics highlights that the company holds more cash than debt on its balance sheet, which can be a positive sign for financial stability. Still, it is also important to note that the company is quickly burning through cash and suffers from weak gross profit margins.
These factors, combined with the expectation that net income is expected to drop this year, paint a cautious picture for the short-term financial health of Theriva.
Investors should also be aware that analysts do not anticipate the company will be profitable this year, and the stock has fared poorly over the last month with a price total return of -20.96%. Such data points are critical for understanding the investment risk profile, especially for a biopharmaceutical company like Theriva Biologics, which is in the process of developing potentially groundbreaking cancer treatments.
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