0001493152-22-028202.txt : 20221012 0001493152-22-028202.hdr.sgml : 20221012 20221012080039 ACCESSION NUMBER: 0001493152-22-028202 CONFORMED SUBMISSION TYPE: 8-K PUBLIC DOCUMENT COUNT: 13 CONFORMED PERIOD OF REPORT: 20221012 ITEM INFORMATION: Regulation FD Disclosure ITEM INFORMATION: Financial Statements and Exhibits FILED AS OF DATE: 20221012 DATE AS OF CHANGE: 20221012 FILER: COMPANY DATA: COMPANY CONFORMED NAME: VBI Vaccines Inc/BC CENTRAL INDEX KEY: 0000764195 STANDARD INDUSTRIAL CLASSIFICATION: PHARMACEUTICAL PREPARATIONS [2834] IRS NUMBER: 000000000 STATE OF INCORPORATION: A1 FISCAL YEAR END: 1231 FILING VALUES: FORM TYPE: 8-K SEC ACT: 1934 Act SEC FILE NUMBER: 001-37769 FILM NUMBER: 221305592 BUSINESS ADDRESS: STREET 1: 160 SECOND STREET STREET 2: CAMBRIDGE CITY: CAMBRIDGE STATE: MA ZIP: 02142 BUSINESS PHONE: 617-830-3031 MAIL ADDRESS: STREET 1: 160 SECOND STREET STREET 2: CAMBRIDGE CITY: CAMBRIDGE STATE: MA ZIP: 02142 FORMER COMPANY: FORMER CONFORMED NAME: SciVac Therapeutics Inc. DATE OF NAME CHANGE: 20150717 FORMER COMPANY: FORMER CONFORMED NAME: LEVON RESOURCES LTD. DATE OF NAME CHANGE: 20100910 FORMER COMPANY: FORMER CONFORMED NAME: LEVON RESOURCES LTD DATE OF NAME CHANGE: 19850305 8-K 1 form8-k.htm
0000764195 false VBI Vaccines Inc/BC 0000764195 2022-10-12 2022-10-12 iso4217:USD xbrli:shares iso4217:USD xbrli:shares

 

 

 

UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

Washington, D.C. 20549

 

FORM 8-K

 

CURRENT REPORT

 

Pursuant to Section 13 or 15(d) of the

Securities Exchange Act of 1934

 

Date of report (Date of earliest event reported): October 12, 2022

 

VBI VACCINES INC.

(Exact name of registrant as specified in its charter)

 

British Columbia, Canada   001-37769   N/A

(State or other jurisdiction

of incorporation)

  

(Commission

File Number)

  

(IRS Employer

Identification No.)

 

160 Second Street, Floor 3

Cambridge, Massachusetts

   02142
(Address of principal executive offices)   (Zip Code)

 

(617) 830-3031

(Registrant’s telephone number, including area code)

 

N/A

(Former Name or former address, if changed since last report)

 

Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions:

 

☐ Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)
   
☐ Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)
   
☐ Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))
   
☐ Pre-commencement communications pursuant to Rule 13e-4© under the Exchange Act (17 CFR 240.13e-4©)

 

Securities registered pursuant to Section 12(b) of the Act:

 

Title of each class   Trading Symbol(s)   Name of exchange on which registered
Common Shares, no par value per share   VBIV   The NASDAQ Stock Market LLC

 

Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (§230.405 of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§240.12b-2 of this chapter).

 

Emerging growth company ☐

 

If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. ☐

 

 

 

 
 

 

Item 7.01 Regulation FD Disclosure.

 

On October 12, 2022, VBI Vaccines Inc. (the “Company”) issued a press release reporting a collaboration with Agenus to evaluate VBI-1901 in combination with Anti-PD-1 Balstilimab in a Phase 2 study in primary glioblastoma patients. A copy of the press release is furnished as Exhibit 99.1 to this Current Report on Form 8-K and is incorporated by reference herein. The Company undertakes no obligation to update, supplement or amend the materials attached hereto.

 

The information in this Current Report on Form 8-K (including Exhibit 99.1 attached hereto) is being furnished pursuant to Item 7.01 and shall not be deemed to be filed for purposes of Section 18 of the Securities Exchange Act of 1934, as amended (the “Exchange Act”), or otherwise be subject to the liabilities of that section, nor shall it be deemed to be incorporated by reference in any filing under the Securities Act of 1933, as amended, or the Exchange Act, whether made before or after the date hereof and regardless of any general incorporation language in such filing.

 

Item 9.01 Financial Statements and Exhibits.

 

(d) Exhibits

 

Exhibit No.   Description
     
99.1   Press Release dated October 12, 2022 (furnished pursuant to Item 7.01)
104   Cover Page Interactive Data File (formatted as Inline XBRL)

 

 
 

 

SIGNATURES

 

Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.

 

  VBI Vaccines Inc.
     
Date: October 12, 2022 By: /s/ Jeffrey R. Baxter
    Jeffrey R. Baxter
    President and Chief Executive Officer

 

 

 EX-99.1 2 ex99-1.htm

 

Exhibit 99.1 

 

VBI Vaccines and Agenus Announce Collaboration to Evaluate VBI-1901 in Combination with Anti-PD-1 Balstilimab in a Phase 2 Study in Primary Glioblastoma Patients

 

-Randomized, controlled evaluation as part of INSIGhT adaptive platform trial expected to initiate around year-end 2022
-Study expected to assess VBI-1901 with concurrent balstilimab (anti-PD-1) administration in frontline Glioblastoma (GBM) patients following primary tumor resection and radiotherapy
-Recurrent GBM Development:

 

○In the ongoing Phase 2a study, one recurrent GBM patient remains on protocol beyond two and a half years with a sustained 93% tumor reduction relative to baseline
○Randomized, controlled extension study of VBI-1901 in recurrent GBM patients expected to initiate Q4 2022, subject to regulatory approvals

 

CAMBRIDGE, MA and LEXINGTON, MA – October 12, 2022 (GLOBE NEWSWIRE) – VBI Vaccines Inc. (Nasdaq: VBIV) (VBI), a biopharmaceutical company driven by immunology in the pursuit of powerful prevention and treatment of disease, and Agenus (NASDAQ: AGEN), an immuno-oncology company with an extensive pipeline of therapeutics designed to activate the immune response to cancers and infections, today announced a collaboration to evaluate the combination of VBI-1901, VBI’s cancer vaccine immunotherapeutic, and balstilimab, Agenus’ monoclonal antibody (mAb) targeting the programmed death receptor-1 (PD-1) protein, in primary glioblastoma (GBM) patients as part of the adaptive platform trial, INSIGhT. Under the agreement, VBI will be the study sponsor and will be responsible for operational execution of the combination trial, and Agenus will provide drug supply and scientific support.

 

Despite being the most common primary brain cancer with approximately 14,000 new cases diagnosed in the United States each year, GBM patients have few effective treatment options and face low survival rates. Even with the standard of care – which includes surgical resection, chemotherapy, and radiation therapy in the frontline setting – primary GBM patients have a five-year survival rate of approximately 10%, with median overall survival of only 15-18 months after diagnosis.1,2

 

David E. Anderson, Ph.D., VBI’s Chief Scientific Officer, commented, “GBMs are notoriously one of the most immunosuppressive solid tumors, which is why there are few effective treatment options. Based upon the encouraging data we have observed to date, we believe VBI-1901 has the potential to activate and boost specific T cell immunity capable of trafficking to the tumor microenvironment. We are now adding an anti-PD-1 monoclonal antibody to the treatment regimen as it may help to further enhance and sustain a meaningful anti-tumor immune response – an anti-PD-1 is designed to prolong the life of these T cells so that they may have greater opportunity to infiltrate and kill tumor cells. Given this potential synergy, we are excited to be partnering with Agenus in this clinical collaboration.”

 

Steven O’Day, M.D., Agenus’ Chief Medical Officer, added, “This clinical collaboration with VBI is aligned with our priority of developing balstilimab as a component of novel combination therapies across a range of tumor types. Balstilimab is a promising anti-PD-1 therapy that has been studied in over 750 patients. Balstilimab has demonstrated clinically meaningful results alone and combined with anti-CTLA-4 therapy in advanced cervical cancer. Combining balstilimab with VBI’s vaccine enhances innate and adaptive anti-tumor immunity and may offer promise to patients with GBM, an aggressive and difficult to treat cancer.”

 

In the recurrent setting, VBI-1901 is in an ongoing Phase 2a study and has demonstrated encouraging tumor responses and improvement in overall survival compared to historical controls. In the arm that will be advanced into the primary setting, there have been two (2) partial responses and five (5) stable disease observations among 16 patients with recurrent GBM. One of the patients with a partial response has been on treatment protocol for more than two and a half years with a sustained tumor response reduction of 93% relative to baseline. These tumor responses have translated to clinical benefit with a median overall survival rate of 12.9 months, which compares favorably to the 8-month overall survival historical control in the recurrent setting after treatment with a monotherapy.3

 

1
 

 

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, 14,000 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 has a high mortality.

 

To learn more about VBI’s ongoing Phase 1/2a study in recurrent GBM and the INSIGhT trial in the frontline setting, visit clinicaltrials.gov (Respective Identifiers: NCT03382977 and NCT02977780).

 

About Balstilimab

 

Balstilimab blocks PD-1 in order to restimulate exhausted T cells and enhance their cytotoxicity. Anti-PD-1 therapy has demonstrated benefit in a number of tumor types and can be well-tolerated when used in combination with other therapeutic approaches. Balstilimab has demonstrated superior tumor-killing potential compared to marketed anti-PD-1 therapies in preclinical models, strong anti-tumor potential in cervical cancer clinical studies and a strong track record of safety and tolerability.4

 

About VBI Vaccines Inc.

 

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.

 

For more information, visit www.vbivaccines.com.

 

About Agenus

 

Agenus is a clinical-stage immuno-oncology company focused on the discovery and development of therapies that engage the body’s immune system to fight cancer and infections. The Company’s vision is to expand the patient populations benefiting from cancer immunotherapy by pursuing combination approaches that leverage a broad repertoire of antibody therapeutics, adoptive cell therapies (through its subsidiary MiNK Therapeutics), and adjuvants (through its subsidiary SaponiQx). The Company is equipped with a suite of antibody discovery platforms and a state-of-the-art GMP manufacturing facility with the capacity to support clinical programs. Agenus is headquartered in Lexington, MA. For more information, please visit www.agenusbio.com and our Twitter handle @agenus_bio. Information that may be important to investors will be routinely posted on our website and Twitter.

 

2
 

 

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 successfully manufacture and commercialize PreHevbrio; 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 pipeline candidates and the commercialization of PreHevbrio; the ability to obtain appropriate or necessary regulatory 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 7, 2022, and filed with the Canadian security authorities at sedar.com on March 7, 2022, 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.

 

Agenus Cautionary Statement on Forward-Looking Information

 

This press release contains forward-looking statements that are made pursuant to the safe harbor provisions of the federal securities laws, including statements relating to Agenus’ technologies, therapeutic candidates, and capabilities, for instance, statements regarding therapeutic benefit and efficacy, mechanism of action, potency, durability, and safety and tolerability profile of our therapeutic candidates, both alone and in combination with each other and/or other agents; statements regarding future plans, including research, clinical, regulatory, and commercialization plans; and any other statements containing the words “may,” “believes,” “expects,” “anticipates,” “hopes,” “intends,” “plans,” “will” and similar expressions are intended to identify forward-looking statements. These forward-looking statements are subject to risks and uncertainties that could cause actual results to differ materially. These risks and uncertainties include, among others, the factors described under the Risk Factors section of Agenus’ most recent Quarterly Report on Form 10-Q or Annual Report on Form 10-K filed with the Securities and Exchange Commission and available on our website: www.agenusbio.com. Agenus cautions investors not to place considerable reliance on the forward-looking statements contained in this release. These statements speak only as of the date of this press release, and Agenus undertakes no obligation to update or revise the statements, other than to the extent required by law. All forward-looking statements are expressly qualified in their entirety by this cautionary statement.

 

References

 

1. National Cancer Institute. Glioblastoma – Unraveling the Threads: A Q&A with Drs. Mark Gilbert and Terri Armstrong of the NIH Neuro-Oncology Branch. August 2017. https://www.cancer.gov/news-events/cancer-currents-blog/2017/glioblastoma-research-making-progress

2. The University of Texas MD Anderson Cancer Center. Glioblastoma. Accessed June 2022. https://www.mdanderson.org/cancer-types/glioblastoma.html

3. Taal W, Oosterkamp HM, Walenkamp AME, et al. Single-agent bevacizumab or lomustine versus a combination of bevacizumab plus lomustine in patients with recurrent glioblastoma (BELOB trial): a randomized controlled phase 2 trial. Lancet Oncol. 2014; 15: 943-953

4. O’Malley DM, et al. Dual PD-1 and CTLA-4 Checkpoint Blockade Using Balstilimab and Zalifrelimab Combination as Second-Line Treatment for Advanced Cervical Cancer: An Open-Label Phase II Study. J Clin Oncol. 2022 Mar 1;40(7):762-771.

 

VBI Contact

 

Nicole Anderson

Director, Corporate Communications & IR

Phone: (617) 830-3031 x124

Email: IR@vbivaccines.com

 

Agenus Contact

 

Ethan Lovell

Chief External Affairs and Communications Officer

Phone: (339) 927-1763

Email: ethan.lovell@agenusbio.com

 

3

 

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