VBI Vaccines Announces Data from VBI-1901 Presented at AACR 2020: Partial Response Observed, Promising Biomarker Strategy Identified

  • Confirmed durable partial response with recurrent GBM tumor reduction of more than 50%
  • Normal baseline CD4+/CD8+ T cell ratio identified as potentially predictive biomarker associated with tumor responses
  • AACR data support further clinical development – exploring registrational study, expected to initiate 2021

VBI Vaccines Inc. (Nasdaq: VBIV) ("VBI"), a commercial-stage biopharmaceutical company developing next-generation infectious disease and immuno-oncology vaccines, today announced that updated Part B data from its ongoing Phase 1/2a study of VBI-1901, the company’s cancer vaccine immunotherapeutic candidate, in recurrent glioblastoma (GBM) patients is being presented in an e-poster at the 2020 American Association for Cancer Research (AACR) Virtual Annual Meeting II, June 22-24, 2020.

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Emerging data from the ongoing Phase 1/2a study suggest that patients with a normal baseline CD4+/CD8+ T cell ratio may be more likely to experience delayed progression or tumor reduction, reflected as a tumor response. Five out of the six tumor responses seen to-date, including a recently confirmed partial response (PR), defined as a tumor reduction of more than 50% per the Response Assessment in Neuro-Oncology (RANO) criteria, suggest that the biomarker may predict patients most likely to respond to, and derive clinical benefit from, treatment with VBI-1901. Based on the data seen to-date, VBI is exploring a randomized, controlled, registrational clinical study for the next phase of development, which, subject to approval from regulatory bodies, could begin in 2021. In parallel, enrollment in the Phase 1/2a Part B study arm of VBI-1901 in combination with GSK’s AS01B adjuvant systems continues, with immunologic and tumor data expected in Q4 2020.

“The identification of the CD4+/CD8+ T cell ratio as a potentially-predictive biomarker and a recently confirmed partial response are more promising developments in what has, to-date, been an encouraging Phase 1/2a clinical study of VBI-1901,” said David E. Anderson, Ph.D., VBI’s Chief Scientific Officer. “The CD4+/CD8+ ratio may reflect the immunologic fitness of CD4+ T cells in recurrent GBM patients and may be used in the next phase of clinical development to help identify patients most likely to respond to VBI-1901. Importantly, testing of the CD4+/CD8+ T cell ratio in this biomarker strategy would use a common assay that could be widely implemented throughout treatment settings. We are working diligently to advance an effective and accessible treatment for GBM patients, who currently have few options available.”

A webcast of Dr. Anderson discussing this data with Allen Waziri, M.D., CEO and Co-Founder, iCE Neurosystems, Former Director of the Brain Tumor Program at Inova Neuroscience Institute, and member of VBI’s GBM/Immuno-Oncology Scientific and Clinical Advisory Board, can be found here: https://www.vbivaccines.com/wire/aacr-2020-video/

The e-poster is available on the “Events/Presentations” page in the “Investors” section of the VBI Vaccines website.

Highlights from the ongoing Phase 1/2a study of VBI-1901 in recurrent GBM patients

  • Safety
    • VBI-1901 continues to be well-tolerated with no vaccine-related safety signals observed at any dose
  • Immunogenicity
    • In Part A, 12-month overall survival (OS) rate of 83% in vaccine responders (n=6) vs. 33% in non-responders (n=9)
    • Vaccine responders saw a 6.25-month improvement in median OS (14.0 months) vs. non-responders (7.75 months)
    • In both Part A and B of the study, tumor responses have been observed in 6 patients: 5 stable disease (SD) and 1 recently confirmed PR, which was previously reported as SD in November 2019
  • CD4+/CD8+ ratio biomarker
    • A normal CD4+/CD8+ T cell ratio present at baseline has been identified as a potentially predictive biomarker correlated with tumor response
    • CD4+ effector memory cells (Tem), a component of this baseline biomarker, are the dominant subset of T cells that are known to depart from the blood and traffic to the tumor microenvironment
    • Patients with tumor responses have shown dynamic loss and boosting of these T cells, which may indicate that the T cells are trafficking to the tumor tissue

About the Phase 1/2a Study Design

VBI’s two-part Phase 1/2a study is a multi-center, open-label, dose-escalation study of VBI-1901 in up to 38 patients with recurrent GBM:

  • Phase 1 (Part A)
    • Dose-escalation phase that defined the safety, tolerability, and optimal dose level of VBI-1901 adjuvanted with granulocyte-macrophage colony-stimulating factor (GM-CSF) in recurrent GBM patients with any number of prior recurrences.
    • This phase enrolled 18 recurrent GBM patients across three dose cohorts of VBI-1901: 0.4 µg, 2.0 µg, and 10.0 µg
    • Enrollment completed in December 2018.
  • Phase 2a (Part B)
    • Subsequent extension of the optimal dose level, 10.0 µg, as defined in the Part A dose escalation phase.
    • This phase is a two-arm study, enrolling 10 first-recurrent GBM patients in each arm, assessing 10.0 µg of VBI-1901 in combination with either GM-CSF or GSK’s proprietary AS01Badjuvant system as immunomodulatory adjuvants.
    • Enrollment of the 10 patients in the GM-CSF arm is complete. Enrollment of the 10 patients in the AS01arm is ongoing.

VBI-1901 is administered intradermally when adjuvanted with GM-CSF and intramuscularly when adjuvanted with the AS01B adjuvant system. Patients in both phases of the study receive the vaccine immunotherapeutic every four weeks until tumor progression.

Per the Response Assessment in Neuro-Oncology (RANO) criteria – an international working group that was created to benchmark brain tumor response – a partial response (PR) is defined as a greater than 50% reduction in the sum of products of perpendicular diameters of all measurable enhancing lesions compared with the baseline, sustained for at least four weeks, with no new lesions or clinical progression of disease.

About VBI-1901 and GBM

VBI-1901 is a novel cancer vaccine immunotherapeutic candidate developed using VBI’s enveloped virus-like particle (eVLP) technology to target two highly immunogenic cytomegalovirus (CMV) antigens, gB and pp65. Scientific literature suggests CMV infection is prevalent in multiple solid tumors, including glioblastoma (GBM). GBM 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. 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.

  • About VBI Vaccines

    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

    Nicole Anderson
    Director, Corporate Communications & IR
    Phone: (617) 830-3031 x124
    Email: info@vbivaccines.com

  • VBI Cautionary Statement on Forward-looking Information

    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.

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    VBI Vaccines Announces Biomarker Data from VBI-1901 Phase 1/2a Study in Recurrent GBM Presented at ESMO Virtual Congress 2020

  • VBI Vaccines Presents Early GBM Tumor Response and Immunologic Data from Part B of Ongoing Phase 1/2a Study of VBI-1901 at the 2019 SNO Annual Meeting

  • VBI Vaccines Announces Late-Breaker Poster Presentation at The Liver Meeting® 2019

  • VBI-poster-ASCO-2019-FINAL

    VBI Vaccines Reports Data from Part A of the Ongoing Phase 1/2a Study of VBI-1901 in Recurrent Glioblastoma (GBM) Patients at ASCO 2019

  • VBIV-EASL-2019-Poster_v2

    VBI Vaccines Announces Late-Breaking Poster Presentation at EASL 2019

  • SNO-2018-Presentation

    VBI Vaccines to Present Initial Data for VBI-1901 in Recurrent Glioblastoma (GBM) Patients at the 2018 Annual Meeting of the Society for Neuro-Oncology (SNO)

  • Keystone Symposia 2016

    VBI Presents New Data Supporting its Glioblastoma Immunotherapy Program at the Keystone Symposia Cancer Vaccines Conference

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