Log in
E-mail
Password
Remember
Forgot password ?
Become a member for free
Sign up
Sign up
New member
Sign up for FREE
New customer
Discover our services
Settings
Settings
Dynamic quotes 
OFFON

MarketScreener Homepage  >  Equities  >  Nasdaq  >  VBI Vaccines Inc.    VBIV   CA91822J1030

VBI VACCINES INC.

(VBIV)
  Report
SummaryQuotesChartsNewsRatingsCalendarCompanyFinancialsConsensusRevisions 
News SummaryMost relevantAll newsPress ReleasesOfficial PublicationsSector news

VBI Vaccines : to Present New Immuno-Oncology Data at the World Vaccine Congress Europe 2019

share with twitter share with LinkedIn share with facebook
share via e-mail
10/24/2019 | 08:06am EDT

- New immunologic and biomarker data from Part A of ongoing Phase 1/2a clinical study of VBI-1901 in recurrent glioblastoma (GBM) patients strengthens correlation between observed vaccine and tumor responses

- New preclinical data further broadens utility of VBI’s enveloped virus-like particle (eVLP) platform technology in the oncology setting

VBI Vaccines Inc. (Nasdaq: VBIV) ("VBI"), a commercial-stage biopharmaceutical company developing next-generation infectious disease and immuno-oncology vaccines, today announced that David E. Anderson, Ph.D., VBI’s Chief Scientific Officer, will present new immuno-oncology data in a presentation titled, “eVLPs as an Antigen Delivery & Immunomodulatory Platform in Cancer,” at the World Vaccine Congress Europe to be held October 29-31, 2019, in Barcelona.

During his presentation, Dr. Anderson will discuss new immunologic and biomarker data from Part A of the ongoing Phase 1/2a clinical study of VBI-1901, VBI’s vaccine immunotherapeutic candidate, in patients with recurrent glioblastoma (GBM). In Part A, three out of the six (3/6) patients in the high-dose cohort had evidence of stable disease by magnetic resonance imaging (MRI), which correlated with vaccine-induced T-cell responses. New assays now demonstrate that in these three vaccine responders, the frequency of harmful, immunosuppressive regulatory T-cells (Tregs) decreases over time, which also correlates with increases of beneficial CD4+ T-helper cells against both antigens contained in VBI-1901, glycoprotein B (gB) and pp65. These expanded biomarkers will also be used to assess responses of patients enrolled in Part B of the study, initial data from which are expected later this year.

“We are encouraged by the data we’ve seen to-date in Part A of the study, but also recognize that in early immuno-oncology clinical studies it is critical to establish a correlation between vaccine responses and observed tumor and clinical responses,” said Dr. Anderson. “This new immunologic and biomarker data further strengthens early activity observed thus far with VBI-1901 and we look forward to seeing the initial data from Part B of the study.”

Dr. Anderson will also discuss preclinical data that supports a broader utility of VBI’s proprietary enveloped virus-like-particle (eVLP) platform technology in oncology.

Presentation Details

- Event: World Vaccine Congress Europe 2019
- Location: Palau de Congressos de Catalunya, Barcelona, Spain
- Date: Tuesday, October 29, 2019
- Time: 5:15 PM CET

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:

  • Part A:
    • Dose-escalation phase that defined the safety, tolerability, and optimal dose level of VBI-1901 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 10.0µg
    • Enrollment completed December 2018
  • Part B:
    • Subsequent extension of the optimal dose level, 10.0 µg, as defined in the Part A dose escalation phase
    • This phase will be a two-arm study, enrolling 10 patients in each arm, assessing VBI-1901 in combination with either GM-CSF or AS01B as immunomodulatory adjuvants
    • Part B will enroll first-recurrent GBM patients only

VBI-1901 is administered intradermally when adjuvanted with granulocyte-macrophage colony-stimulating factor (GM-CSF), and will be administered intramuscularly when adjuvanted with GSK proprietary AS01B adjuvant system. Patients in both phases of the study will receive the vaccine immunotherapeutic every four weeks until clinical progression.

Additional information, including a detailed description of the study design, eligibility criteria, and investigator sites, is available at ClinicalTrials.gov using identifier NCT03382977.

About VBI Vaccines Inc.

VBI Vaccines Inc. (Nasdaq: VBIV) is a commercial-stage biopharmaceutical company developing a next generation of vaccines to address unmet needs in infectious disease and immuno-oncology. VBI is advancing the prevention and treatment of hepatitis B, with the only commercially-approved trivalent hepatitis B vaccine, Sci-B-Vac®, which is approved for use in Israel and 10 other countries and is currently in a Phase 3 program in the U.S., Europe, and Canada, and with an immunotherapeutic in development for a functional cure for chronic hepatitis B. VBI’s eVLP Platform technology allows for the development of enveloped virus-like particle (eVLP) vaccines that closely mimic the target virus to elicit a potent immune response. Integrating its cytomegalovirus (CMV) expertise with the eVLP platform technology, VBI’s lead eVLP program candidates include a prophylactic CMV vaccine candidate and a glioblastoma (GBM) vaccine immunotherapeutic candidate. VBI is headquartered in Cambridge, MA with research operations in Ottawa, Canada and research and manufacturing facilities in Rehovot, Israel.

Website Home: http://www.vbivaccines.com/

News and Insights: http://www.vbivaccines.com/wire/

Investors: http://www.vbivaccines.com/investors/

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 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 Securities and Exchange Commission and the Canadian securities authorities, including its Annual Report on Form 10-K filed with the Securities and Exchange Commission on February 25, 2019, and filed with the Canadian security authorities at sedar.com on February 25, 2019, 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.


© Business Wire 2019
share with twitter share with LinkedIn share with facebook
share via e-mail
Latest news on VBI VACCINES INC.
03/12VBI VACCINES : Appoints Damian Braga to Board of Directors
BU
03/05VBI VACCINES : Provides Corporate Update, Outlook for 2020, and Year-End 2019 Fi..
BU
03/03VBI VACCINES : Provides Update on Part A of Ongoing Phase 1/2a Study Demonstrati..
BU
03/02VBI VACCINES : Announces Dosing of First Recurrent GBM Patient in Phase 2a Study..
BU
01/14VBI VACCINES : Regains Compliance with Nasdaq Minimum Bid Price Requirement
BU
01/09VBI VACCINES : Announces Second Pivotal Phase 3 Study of Sci-B-Vac® Meets Primar..
BU
2019VBI VACCINES : Presents Early GBM Tumor Response and Immunologic Data from Part ..
PU
2019VBI VACCINES : Presents Early GBM Tumor Response and Immunologic Data from Part ..
BU
2019VBI VACCINES : and Brii Biosciences Initiate Phase 1b/2a Study of BRII-179 (VBI-..
BU
2019VBI VACCINES : to Present Initial Phase 1/2a Part B Data of VBI-1901 at the 2019..
BU
More news
Financials (USD)
Sales 2020 3,38 M
EBIT 2020 -47,6 M
Net income 2020 -49,4 M
Debt 2020 -
Yield 2020 -
P/E ratio 2020 -3,53x
P/E ratio 2021 -4,11x
Capi. / Sales2020 49,0x
Capi. / Sales2021 34,0x
Capitalization 166 M
Chart VBI VACCINES INC.
Duration : Period :
VBI Vaccines Inc. Technical Analysis Chart | MarketScreener
Full-screen chart
Technical analysis trends VBI VACCINES INC.
Short TermMid-TermLong Term
TrendsNeutralNeutralNeutral
Income Statement Evolution
Consensus
Sell
Buy
Mean consensus BUY
Number of Analysts 4
Average target price 4,25  $
Last Close Price 0,93  $
Spread / Highest target 437%
Spread / Average Target 357%
Spread / Lowest Target 222%
EPS Revisions
Managers
NameTitle
Jeffrey R. Baxter President, Chief Executive Officer & Director
Steven H. Gillis Chairman
Christopher McNulty CFO, Director & Head-Business Development
David Evander Anderson Chief Scientific Officer
Francisco Diaz-Mitoma Chief Medical Officer
Sector and Competitors
1st jan.Capitalization (M$)
VBI VACCINES INC.-32.57%166
LONZA GROUP11.21%29 660
IQVIA HOLDINGS INC.-30.66%20 658
CELLTRION, INC.3.08%20 147
SEATTLE GENETICS, INC.-4.37%18 823
INCYTE CORPORATION-21.03%14 949