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VBI Vaccines Inc. (NASDAQ: VBIV) is a leading biopharmaceutical company focused on developing next-generation vaccines to meet unmet needs in infectious diseases and immuno-oncology. Headquartered in Cambridge, MA, with research facilities in Ottawa, Canada, VBI is at the forefront of vaccine innovation with two primary platforms.
The first platform, Enveloped Virus-Like Particle (eVLP), enables the design of vaccines that closely mimic the target virus, enhancing their effectiveness. The company's lead eVLP asset is a prophylactic cytomegalovirus (CMV) vaccine, currently advancing with GMP manufacturing for formal preclinical and Phase I trials.
The second platform is a thermostable technology allowing vaccines and biologics to withstand fluctuating temperatures during storage and transport. VBI has completed proof-of-concept thermostability studies on several vaccine and biologic targets, highlighting this platform's potential to improve global vaccine distribution.
VBI's commercial product, Sci-B-Vac, is a hepatitis B (HBV) vaccine approved for adults, children, and newborns. The company's innovations are designed to address significant gaps in the vaccine market, particularly in underserved areas.
Recent achievements include the initiation of GMP manufacturing for its CMV vaccine candidate and successful proof-of-concept studies for its thermostable technology. VBI continues to be a pivotal player in the biopharmaceutical field, dedicated to advancing public health through cutting-edge vaccine solutions.
VBI Vaccines Inc. (NASDAQ: VBIV) announced promising preclinical results for its COVID-19 vaccine candidates, VBI-2905 and VBI-2901. VBI-2905 showed robust neutralizing and antibody binding activity against COVID-19 variants Beta and Delta. The Phase 1b clinical study has commenced, aiming to determine VBI-2905's efficacy as both a single booster and a primary series vaccine. Initial data from the study is anticipated in early Q1 2022. The company will discuss these findings and its broader coronavirus strategy on a conference call scheduled for September 29, 2021.
VBI Vaccines Inc. (Nasdaq: VBIV) reported Q2 2021 financial results, including key achievements in its vaccine pipeline. The FDA granted Fast Track Designation for VBI-1901 in recurrent glioblastoma. Notable advancements also included positive Phase 1 data for the COVID-19 vaccine candidate, VBI-2902, and a unique CPT code for their 3-antigen HBV vaccine. Financially, VBI reported revenue of $0.1 million, a decrease from $0.2 million in Q2 2020. R&D expenses rose to $4.6 million due to COVID-19 vaccine development, while net loss expanded to $17.5 million, up from $9.5 million a year earlier.
VBI Vaccines Inc. (Nasdaq: VBIV) has announced the appointment of Linda Bain, former CFO of Codiak BioSciences, to its Board of Directors. Bain brings over 20 years of financial and strategic experience in the biotech sector, having successfully guided companies through IPOs and financing initiatives. VBI's leadership expressed confidence in her ability to advance their corporate strategy and clinical pipeline, particularly the upcoming launch of their 3-antigen hepatitis B vaccine candidate. Bain has previously held significant roles at various biotech firms and financial institutions.
VBI Vaccines Inc. (Nasdaq: VBIV) announced that the American Medical Association (AMA) has established a unique CPT code for its 3-antigen Hepatitis B vaccine candidate, differentiating it from single-antigen vaccines. This milestone supports a streamlined reimbursement process and is crucial as the vaccine is under regulatory review in the U.S. and Europe, with a target action date set by the FDA for November 30, 2021. VBI's vaccine, comprising S, Pre-S1, and Pre-S2 antigens, is already approved in Israel and currently involved in pivotal clinical studies.
VBI Vaccines Inc. (Nasdaq: VBIV) reported positive Phase 1 results for its COVID-19 vaccine candidate VBI-2902a, demonstrating substantial immune responses in healthy adults aged 18-54. The 5µg dose elicited neutralization titers 4.3 times higher than convalescent sera, indicating strong efficacy. No safety signals were observed, supporting its well-tolerated profile. VBI plans to advance to the next phase with VBI-2905a targeting the Beta variant in Q3 2021, and to initiate a multivalent candidate study in H1 2022, as part of its ongoing commitment to effective COVID-19 solutions.
Brii Biosciences and VBI Vaccines announced final results from a Phase 1b/2a study of BRII-179 (VBI-2601) for chronic hepatitis B. The candidate showed safety and induced both B cell and T cell responses, with no safety signals. The study presented data at EASL's International Liver Congress, selected for the 'Best of ILC' summary. A Phase 2 trial is ongoing in combination with BRII-835 (VIR-2218), essential for addressing chronic HBV, which affects 290 million worldwide. Key findings revealed that 77% of patients developed T cell responses, with 44.2% showing antibody responses.
VBI Vaccines Inc. (Nasdaq: VBIV) announced acceptance of two abstracts for e-poster presentations at significant upcoming conferences. The abstracts from the Phase 3 clinical program for the 3-antigen hepatitis B vaccine (3A-HBV) will be presented at the Global Hepatitis Summit (June 18-20, 2021) and the American Diabetes Association’s Virtual Scientific Sessions (June 25-29, 2021). The vaccine, currently available in Israel, aims to enhance protection against hepatitis B, a major health threat affecting over 290 million individuals globally.
VBI Vaccines Inc. (Nasdaq: VBIV) announced the results from its annual general meeting held on June 9, 2021. A total of 162,568,059 Common Shares were represented, accounting for 63.99% of the issued shares. All seven director nominees received substantial support, with votes for each exceeding 94%. EisnerAmper LLP was appointed as the independent registered public accounting firm for the upcoming year. VBI aims to advance immunology-driven solutions for infectious diseases and cancers, utilizing its proprietary vaccine technology.
VBI Vaccines Inc. (Nasdaq: VBIV) announced two abstracts accepted for presentation at The Digital International Liver Congress™ 2021, focusing on their hepatitis B vaccine candidates. The VBI-2601 (BRII-179) immunotherapeutic candidate aims to restore immune responses in chronic HBV patients, while the 3-antigen prophylactic vaccine exhibits rapid protection in young adults. With over 290 million HBV infections globally, VBI targets significant health threats through innovative vaccine development. The presentations will take place from June 23-26, 2021.
VBI Vaccines Inc. (Nasdaq: VBIV) has received Fast Track Designation from the FDA for its cancer vaccine, VBI-1901, aimed at treating recurrent glioblastoma (GBM) patients. This designation accelerates the development and review of therapies for serious conditions. The company reported encouraging clinical data, showing improved overall survival rates compared to historical controls. VBI-1901 is developed with VBI's eVLP technology, targeting CMV antigens, a concern in GBM. This milestone is seen as crucial for advancing treatment options for patients with limited alternatives.
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