CAMBRIDGE, Mass. - VBI Vaccines Inc. (NASDAQ:VBIV), a biopharmaceutical company, revealed interim data from a Phase 2b study of their experimental cancer vaccine, VBI-1901, which is being tested in patients with recurrent glioblastoma (rGBM).
The data, which will be presented at the American Society of Clinical Oncology (ASCO) Annual Meeting on June 1, 2024, indicates a 43% disease control rate in the VBI-1901 study arm.
As of May 15, 2024, seven patients treated with VBI-1901 long enough to have at least one MRI scan showed one partial tumor response (PR) and two stable disease (SD) observations. The partial response was marked by a 67% reduction in tumor size at week 6 after two doses of the vaccine.
In contrast, the control arm, which received standard-of-care therapy, saw a 0% disease control rate with most patients experiencing significant tumor growth and being taken off the study protocol.
The U.S. Food and Drug Administration (FDA) has granted VBI-1901 Fast Track and Orphan Drug Designations, which may expedite the drug development process. Additional interim data, including more tumor response and initial survival data, are expected in the fourth quarter of 2024.
The Phase 2b study is a multi-center, randomized, controlled, open-label study in up to 60 patients with first recurrent GBM. The primary endpoints include safety, tolerability, overall survival, tumor response rate, progression-free survival, immunologic responses, reduction in corticosteroid use, and quality of life changes.
Glioblastoma is a particularly aggressive and common brain tumor, with approximately 12,000 new cases diagnosed annually in the U.S. alone. Current treatments involve surgery, radiation, and chemotherapy, but the prognosis remains poor, with a median overall survival of about eight months.
VBI-1901 utilizes the company's enveloped virus-like particle (eVLP) technology to target two cytomegalovirus (CMV) antigens believed to be prevalent in multiple solid tumors, including GBM. The vaccine aims to stimulate an immune response against these antigens.
VBI Vaccines is focused on leveraging its immunology expertise to develop preventive and therapeutic vaccines for infectious diseases and cancer. The company operates research facilities in Massachusetts, Ottawa, Canada, and Rehovot, Israel.
This news article is based on a press release statement.
InvestingPro Insights
As VBI Vaccines Inc. (NASDAQ:VBIV) continues to make strides in the development of its experimental cancer vaccine, VBI-1901, the financial landscape of the company presents a complex picture. According to InvestingPro data, VBI Vaccines has a market capitalization of $18.36 million, reflecting the size of the company in the biopharmaceutical industry.
Despite significant revenue growth in the last twelve months as of Q1 2024, with an impressive increase of 553.09%, the company faces challenges with a negative gross profit margin of -24.02% during the same period. This indicates that the cost of goods sold exceeds the revenue generated, which is a concern for profitability.
InvestingPro Tips highlight the company's significant debt burden and its quick cash burn rate, which are important considerations for investors. These factors, coupled with the company's weak gross profit margins, suggest a cautious approach to the stock. Moreover, the company has been marked by volatile stock price movements, and while the price has seen a strong return over the last month, it has fallen significantly over the past year.
For those interested in a deeper analysis, there are additional InvestingPro Tips available that can provide further insight into VBI Vaccines' financial health and future prospects. For instance, analysts predict that the company will be profitable this year, which could be a turning point for the company if the forecast holds true. To explore these additional tips and metrics, readers can visit the InvestingPro platform at https://www.investing.com/pro/VBIV.
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