VBI-1901 shows promise in glioblastoma study

CAMBRIDGE, Mass. - VBI Vaccines Inc. (NASDAQ: NASDAQ:VBIV) reported early data from a Phase 2b study of VBI-1901, its cancer vaccine immunotherapeutic candidate for recurrent glioblastoma (rGBM), at the World Vaccine Congress on Monday. The preliminary results revealed a 40% disease control rate in the treatment arm, a potential signal of efficacy in a disease known for aggressive tumor growth and limited treatment options.

The study, which is ongoing, has randomized 17 patients to receive either VBI-1901 or standard-of-care therapy. Early observations from the 12-week evaluation showed two instances of stable disease, indicating no tumor progression, among five evaluable patients in the VBI-1901 arm. In contrast, all six evaluable patients in the control arm experienced tumor growth, with no disease control observed.

The U.S. Food and Drug Administration (FDA) has previously granted VBI-1901 both Fast Track Designation and Orphan Drug Designation, following encouraging results from an earlier Phase 1/2a study. That study showed an improved median overall survival of approximately five months compared to historical controls.

The current Phase 2b study aims to enroll up to 60 patients with first recurrent GBM, assessing various endpoints including safety, overall survival, tumor response rate, and immunologic responses. Interim data from the trial is expected to be released mid-year and at the end of 2024.

Glioblastoma is one of the most common and aggressive brain tumors, with 14,000 new cases diagnosed annually in the U.S. alone. The standard treatment includes surgery, radiation, and chemotherapy, but the prognosis remains poor, underscoring the urgency for more effective therapies.

VBI's vaccine candidate, VBI-1901, utilizes the company's enveloped virus-like particle technology to target cytomegalovirus (CMV) antigens, which are believed to be present in various solid tumors, including GBM.

As the study progresses, VBI continues to recruit patients at neuro-oncology centers across the United States, with additional clinical sites being activated. The information presented is based on a press release statement from VBI Vaccines Inc.

As VBI Vaccines Inc. (NASDAQ: VBIV) continues to show promise in its clinical trials, the financial metrics and analyst insights provide an additional layer of information for investors monitoring the company's progress. According to real-time data from InvestingPro, VBI Vaccines has a market capitalization of $16.58 million, reflecting the size of the company in the biotechnology space. Despite challenges, revenue growth has been striking, with an increase of 833.56% in the last twelve months as of Q1 2023.

Notably, the company's gross profit margin stands at -58.73% for the same period, indicating that while revenues are growing, the cost of goods sold is still higher than the revenue generated. This is a critical factor, as it reflects the current stage of the company's development and its investment in research and development for its vaccine candidates.

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InvestingPro Tips highlight that analysts are optimistic about the company's future, expecting net income to grow this year and predicting that VBI will be profitable this year. Additionally, they anticipate sales growth in the current year, aligning with the company's clinical advancements. However, it's important to note that the stock has experienced significant volatility, and the company has been quickly burning through cash, which could impact its short-term financial stability.

For investors looking for comprehensive analysis and additional insights, there are 15 more InvestingPro Tips available at https://www.investing.com/pro/VBIV. These tips could provide a deeper understanding of VBI Vaccines' financial health and market position. Moreover, by using the coupon code PRONEWS24, readers can get an additional 10% off a yearly or biyearly Pro and Pro+ subscription to InvestingPro, unlocking a wealth of data and expert analysis to inform investment decisions.

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