VBI Presents Update and New Data Supporting its Glioblastoma Immunotherapy Program at the ESMO Symposium on Immuno-Oncology

November 20, 2015 | Glioblastoma ("GBM"), Press Releases

VBI Vaccines Inc. (Nasdaq: VBIV) (“VBI”) today presented an update and new data supporting its glioblastoma multiforme (“Glioblastoma” or “GBM”) cancer immunotherapy program at the European Society for Medical Oncology (“ESMO”) Immuno-Oncology Symposium.

During the poster presentation, Therapeutic Vaccination against Glioblastoma Multiforme Using CMV gB/pp65 eVLPs Formulated with GM-CSF, Dr. David E. Anderson, Ph.D., VBI’s Chief Scientific Officer, summarized recent milestones in VBI’s development of a therapeutic glioblastoma vaccine.

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GBM Program Highlights

Ex vivo studies demonstrate the vaccine candidate’s ability to induce desired anti-tumor immunity in peripheral blood mononuclear cells (“PBMCs”) harvested from healthy subjects and patients with GBM; GBM patient samples were provided by Columbia University’s Brain Tumor Center. The vaccine candidate stimulated both CD4+ and CD8+ T cell responses, characterized by secretion of IFN-g and CCL3, key biomarkers associated with positive clinical outcomes.^1,2
In vivo data confirm the vaccine candidate’s ability to induce desired CD4+ and CD8+ T cell responses in mice; additional animal studies are planned to determine optimal dosing and formulation properties.
Characterization data confirm the desired integrity and quality of the vaccine candidate; pilot (10L) scale production is now underway at a GMP-compliant facility and a pre-IND meeting is planned with the U.S. FDA in H1 2016.

GBM Program Background

Glioblastoma is among the most common and aggressive malignant primary brain tumors in humans. In the U.S. alone, 12,000 new cases are diagnosed each year.³ The current standard of care for treating GBM is surgical resection, followed by radiation and chemotherapy. Even with aggressive treatment, GBM progresses rapidly and is exceptionally lethal, with median patient survival of less than 16 months.⁴

Targeted immunotherapy may provide a promising adjunct or alternative to conventional GBM treatment. Immunotherapy is a fundamentally different way of treating cancer that stimulates the patient’s immune system to resume its attack on tumors. While conventional therapies are non-specific and may damage surrounding normal tissues, targeted immunotherapy may offer a highly specific and potentially long-lasting treatment approach that leverages our immune system to protect against cancer.

Developing a broadly applicable GBM immunotherapy requires the identification of antigens, used to direct the immune response, that are consistently expressed on tumor cells. A growing body of research has demonstrated that GBM tumors are susceptible to infection by cytomegalovirus (“CMV”), with over 90% of GBM tumors expressing CMV antigens.⁵ In addition, recent research has demonstrated that an anti-CMV dendritic cell vaccination regimen can extend overall survival in patients with glioblastoma.⁶ Thus, effective targeting of CMV antigens may represent an attractive strategy for a GBM immunotherapy.

VBI seeks to leverage its eVLP Platform and its expertise in anti-CMV immunity to develop a bivalent therapeutic vaccine candidate designed to direct an immune response against gB and pp65, two CMV antigens that are highly immunogenic targets during natural infection. The vaccine candidate includes granulocyte-macrophage colony-stimulating factor (“GM-CSF”), an adjuvant that mobilizes dendritic function and enhances Th1-type immunity.⁷

Preclinical Findings

In recently completed preclinical studies, VBI demonstrated that its vaccine candidate stimulated immune responses critical to efficacious anti-tumor immunity. In studies conducted using peripheral blood mononuclear cells (“PBMCs”), harvested from healthy subjects and patients with GBM, the vaccine candidate stimulated strong CD4+ and CD8+ T cell responses ex vivo, characterized by secretion of IFN-g and CCL3, key biomarkers associated with positive clinical outcomes. GBM patient samples were provided by Columbia University’s Brain Tumor Center.

In a mouse study, VBI’s vaccine candidate induced desired anti-tumor immunity in vivo, expanding both CD4+ and CD8+ T cell responses. Additional mouse studies are planned to determine optimal dosing and formulation properties.

“A limitation of some past therapeutic cancer vaccines, and one reason more patients do not respond to checkpoint inhibitors, is the inherently poor immunogenicity of tumor-associated antigens derived from ’self’ tissues,” said Dr. Anderson. “While early, these preclinical findings suggest that VBI’s candidate, a bivalent vaccine comprised of highly immunogenic ’foreign’ viral tumor-associated antigens, may be able to overcome this past issue and better activate and expand GBM-specific CD4+ and CD8+ T cell responses.”

Vaccine Candidate Manufacture and Next Steps

Pilot (10L) scale production of VBI’s vaccine candidate is now underway at a GMP-compliant facility. During recent testing, VBI employed electron microscopy to confirm the integrity of the bivalent eVLPs, with positive interim results. Purity measurements are expected to meet regulatory requirements for clinical evaluation of the vaccine candidate. A pre-IND meeting is planned with the U.S. FDA in H1 2016.

To learn more about VBI’s GBM Immunotherapy Program, visit: https://www.vbivaccines.com/gbm/

References

Galon J, Costes A, Sanchez-cabo F, et al. Type, density, and location of immune cells within human colorectal tumors predict clinical outcome. Science. 2006;313(5795):1960-4.
Mitchell DA, Batich KA, Gunn MD, et al. Tetanus toxoid and CCL3 improve dendritic cell vaccines in mice and glioblastoma patients. Nature. 2015;519(7543):366-9.
Dolecek TA, Propp JM, Stroup NE, et al. (2012) CBTRUS statistical report: Primary brain and central nervous system tumors diagnosed in the United States in 2005-2009. Neuro Oncol 14(suppl 5):v1–v49.
Johnson DR, O’neill BP. Glioblastoma survival in the United States before and during the temozolomide era. J Neurooncol. 2012;107(2):359-64.
Mitchell DA, Xie W, Schmittling R, et al. Sensitive detection of human cytomegalovirus in tumors and peripheral blood of patients diagnosed with glioblastoma. Neuro-oncology. 2008;10(1):10-8.
Mitchell DA, Batich KA, Gunn MD, et al. Tetanus toxoid and CCL3 improve dendritic cell vaccines in mice and glioblastoma patients. Nature. 2015;519(7543):366-9.
Arellano M, Lonial S. Clinical uses of GM-CSF, a critical appraisal and update. Biologics. 2008;2(1):13-27.

About VBI Vaccines

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VBI Vaccines Inc. (“VBI”) is a biopharmaceutical company driven by immunology in the pursuit of powerful prevention and treatment of disease. Through its innovative approach to virus-like particles (“VLPs”), including a proprietary enveloped VLP (“eVLP”) platform technology, VBI develops vaccine candidates that mimic the natural presentation of viruses, designed to elicit the innate power of the human immune system. VBI is committed to targeting and overcoming significant infectious diseases, including hepatitis B, coronaviruses, and cytomegalovirus (CMV), as well as aggressive cancers including glioblastoma (GBM). VBI is headquartered in Cambridge, Massachusetts, with research operations in Ottawa, Canada, and a research and manufacturing site in Rehovot, Israel.
VBI Investor and Media Contact

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Nicole Anderson
Director, Corporate Communications & IR
Phone: (617) 830-3031 x124
Email: info@vbivaccines.com
VBI Cautionary Statement on Forward-looking Information

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Certain statements in this press release that are forward-looking and not statements of historical fact are forward-looking statements within the meaning of the safe harbor provisions of the Private Securities Litigation Reform Act of 1995 and are forward-looking information within the meaning of Canadian securities laws (collectively, “forward-looking statements”). The Company cautions that such statements involve risks and uncertainties that may materially affect the Company’s results of operations. Such forward-looking statements are based on the beliefs of management as well as assumptions made by and information currently available to management. Actual results could differ materially from those contemplated by the forward-looking statements as a result of certain factors, including but not limited to, the impact of general economic, industry or political conditions in the United States or internationally; the impact of the ongoing COVID-19 pandemic on our clinical studies, manufacturing, business plan, and the global economy; the ability to establish that potential products are efficacious or safe in preclinical or clinical trials; the ability to establish or maintain collaborations on the development of therapeutic candidates; the ability to obtain appropriate or necessary governmental approvals to market potential products; the ability to obtain future funding for developmental products and working capital and to obtain such funding on commercially reasonable terms; the Company’s ability to manufacture product candidates on a commercial scale or in collaborations with third parties; changes in the size and nature of competitors; the ability to retain key executives and scientists; and the ability to secure and enforce legal rights related to the Company’s products. A discussion of these and other factors, including risks and uncertainties with respect to the Company, is set forth in the Company’s filings with the SEC and the Canadian securities authorities, including its Annual Report on Form 10-K filed with the SEC on March 5, 2020, and filed with the Canadian security authorities at sedar.com on March 5, 2020, as may be supplemented or amended by the Company’s Quarterly Reports on Form 10-Q. Given these risks, uncertainties and factors, you are cautioned not to place undue reliance on such forward-looking statements, which are qualified in their entirety by this cautionary statement. All such forward-looking statements made herein are based on our current expectations and we undertake no duty or obligation to update or revise any forward-looking statements for any reason, except as required by law.