OXFORD, United Kingdom - Barinthus Biotherapeutics plc (NASDAQ: BRNS), a biopharmaceutical company focused on T cell immunotherapeutics, announced final data from the APOLLO trial of VTP-200, a treatment for cervical lesions associated with high-risk HPV infections. The trial met its primary safety endpoint, showing the treatment was well-tolerated with no serious adverse events related to the treatment.
The Phase 1b/2 trial involved 108 participants across the UK and EU, assessing the safety and immunogenicity of VTP-200 in women aged 25-55 with persistent high-risk HPV infection and low-grade cervical lesions. The study's primary goal was to evaluate the treatment's safety and tolerability.
Results indicated positive trends in the clearance rate of high-risk HPV and cervical lesions in groups receiving the highest dose of the ChAdOx vector. Specifically, a 60% clearance rate for HPV and a 67% clearance rate for cervical lesions were observed in these groups, compared to a 33% and 39% clearance rate in the placebo group, respectively.
Still, when data from all active dose groups were pooled, there was no statistically significant improvement compared to the placebo group.
Barinthus Bio noted that the differences observed were not statistically significant as the trial was not powered for individual dose group comparisons. The company is evaluating future development options for the VTP-200 program, with further analyses focusing on immunological responses.
VTP-200 consists of an initial dose using the ChAdOx vector and a second dose using the MVA vector, both encoding HPV antigens, designed to elicit an antigen-specific T cell immune response. It is being developed as a potential non-invasive treatment for persistent high-risk HPV infections and associated pre-cancerous cervical lesions.
The company is advancing a pipeline of product candidates across a range of therapeutic areas, including chronic infectious diseases, autoimmunity, and cancer. The detailed results of the APOLLO trial are expected to be shared in due course.
This article is based on a press release statement from Barinthus Bio.
InvestingPro Insights
As Barinthus Biotherapeutics plc (NASDAQ: BRNS) releases promising safety data from its APOLLO trial, investors are closely monitoring the company's financial health and market performance.
According to InvestingPro, BRNS holds more cash than debt on its balance sheet, which could provide financial flexibility as the company evaluates the future of its VTP-200 program. However, the company is quickly burning through cash, and analysts have revised their earnings downwards for the upcoming period, reflecting potential concerns about the company's short-term profitability.
From a market perspective, BRNS's stock has taken a significant hit over the last week, with a total price return of -21.92%. This volatility is noteworthy, especially given that the stock price often moves in the opposite direction of the market.
The company's current market capitalization stands at $101.2 million, with a negative adjusted P/E ratio of -1.42 for the last twelve months as of Q4 2023, indicating that the company is not profitable over this period.
Investors looking for more in-depth analysis can find additional InvestingPro Tips for BRNS, which include insights such as the company's weak gross profit margins and the expectation that net income will drop this year.
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