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VBI Vaccines Inc. (NASDAQ: VBIV) presented additional biomarker data from its Phase 1/2a study of VBI-1901, a cancer vaccine for recurrent glioblastoma (GBM), at the Society for Neuro-Oncology meeting on November 18, 2022. The study showed two partial tumor responses and stable disease in five patients, with a median overall survival of 12.9 months, significantly better than the standard care's 8 months. Six of seven responders exhibited normal CD4+/CD8+ T cell ratios, suggesting a link between immune response and treatment efficacy, guiding future patient selection for clinical trials.
VBI Vaccines Inc. (Nasdaq: VBIV) announced participation in analyst-led fireside chats at two investor conferences. The first is Guggenheim’s 4th Annual Immunology and Neurology Day on November 15, 2022, where CFO Christopher McNulty will present from 3:20-3:45 PM ET. The second is the Jefferies London Healthcare Conference on November 16, 2022, with President & CEO Jeff Baxter presenting from 8:00-8:30 AM GMT. Live webcasts will be available on VBI’s website, with replays archived post-event.
VBI Vaccines Inc. (Nasdaq: VBIV) announced that its abstract for VBI-1901, a cancer vaccine candidate for recurrent glioblastoma (GBM), has been accepted for poster presentation at the Society for Neuro-Oncology's 27th Annual Meeting on November 18, 2022. The study focuses on biomarker analysis of responders vs. non-responders in the Phase 2a trial. GBM, a prevalent and aggressive brain tumor, sees 12,000 new cases yearly in the U.S. The research aims to enhance immunotherapeutic approaches targeting cytomegalovirus antigens associated with GBM.
VBI Vaccines reported a significant Q3 2022, highlighting a collaboration with Valneva for the commercialization of the PreHevbrio hepatitis B vaccine in Europe. The company initiated its first clinical study of VBI-2901, a COVID-19 vaccine candidate, and secured a $100 million upsized debt facility. Financially, VBI ended Q3 with $83.6 million in cash. They recorded $0.3 million in revenue, up from $0.1 million year-over-year, but faced a net loss of $25.2 million, compared to a $15.9 million loss last year, driven by increased operational costs and foreign exchange losses.
VBI Vaccines Inc. (Nasdaq: VBIV) will participate in the H.C. Wainwright 3rd Annual Hepatitis B Virus Conference on Tuesday, October 18, 2022. CEO Jeff Baxter and Chief Scientific Officer David E. Anderson will engage in an analyst-led fireside chat scheduled from 9:00-9:30 AM ET. Investors can access a live webcast of the presentation on VBI’s website, with an archived replay available post-event. VBI focuses on innovative vaccine development targeting infectious diseases and aggressive cancers, utilizing its proprietary enveloped virus-like particle technology.
VBI Vaccines and Agenus announced a collaboration to study VBI-1901, a cancer vaccine, in combination with Agenus's balstilimab for primary glioblastoma (GBM) patients. The INSIGhT adaptive platform trial is set to begin around year-end 2022, focusing on GBM patients post-tumor resection and radiotherapy. Promising results from an ongoing Phase 2a study show one patient sustained a 93% tumor reduction over two and a half years. The collaboration aims to enhance anti-tumor immunity in an area with limited treatment options.
VBI Vaccines Inc. has initiated a Phase 1 clinical study for its multivalent COVID-19 vaccine candidate, VBI-2901, designed to enhance protection against COVID-19 and related coronaviruses. The study will enroll approximately 100 healthy adults in Canada, with interim data expected mid-2023. Preclinical findings indicate that VBI-2901 generates a robust immune response against various coronavirus variants, including recent strains BA.4 and BA.5. The study is supported by the Government of Canada's Innovation Fund.
VBI Vaccines Inc. (Nasdaq: VBIV) announced the presentation of data from a compassionate use study of its 3-antigen hepatitis B vaccine at the 2022 International HBV Meeting in Paris on September 19. The study involved four adults chronically infected with hepatitis B virus. The vaccine, which includes three surface antigens of HBV, is approved in the US, EU, UK, and Israel. With over 290 million people infected globally, hepatitis B presents a significant health challenge, leading to severe liver disease and related deaths annually.
VBI Vaccines Inc. (NASDAQ: VBIV) has announced a refinanced and upsized debt facility of up to $100 million with K2 HealthVentures. This facility includes $50 million immediately accessible, with $30 million allocated for refinancing and $20 million as non-dilutive funding. Additional tranches of $25 million will be available upon meeting clinical and financial milestones. This funding supports VBI’s ongoing commercial launch of PreHevbrio™ and advancements in its vaccine pipeline.
Valneva and VBI Vaccines have formed a partnership for the marketing and distribution of PreHevbri®, the only 3-antigen hepatitis B vaccine approved in Europe. Valneva will distribute the vaccine in select European markets, including the UK, Sweden, Norway, Denmark, Finland, Belgium, and the Netherlands, with availability expected in early 2023. This collaboration signifies Valneva's commitment to vaccine commercialization and aims to enhance access to this critical vaccine, which targets over 290 million globally infected with hepatitis B.