NewLink Genetics Announces Merck Has Begun Rolling Submission of Licensure Application for Ebola vaccine V920 (rVSV∆G-ZEBOV...
16 November 2018 - 1:00AM
In 2014 the Company entered into a license agreement
with Merck to develop, manufacture and commercialize NewLink
Genetics’ Ebola vaccine candidate
NewLink Genetics Corporation (NASDAQ:NLNK) reported today that
Merck has begun the submission of a rolling Biologics License
Application (BLA) to the U.S. Food and Drug Administration (FDA)
for V920 (rVSV∆G-ZEBOV-GP, live attenuated). This rolling
submission is made pursuant to the FDA’s Breakthrough Therapy
Designation for V920, which was announced by Merck in July 2016 and
is anticipated to be completed in 2019.
The FDA’s approval of this Ebola vaccine would
trigger the issuance of a priority review voucher owned by Merck
and in which NewLink Genetics has a substantial economic
interest. Thereafter, NewLink would have the right to
monetize its share of interest in the voucher. This Ebola
vaccine candidate was originally developed by the Public Health
Agency of Canada (PHAC) and thereafter licensed to NewLink
Genetics. Additional information related to this Ebola
vaccine candidate may be found in the most recent 10Q and other
filings under the “Investors & Media” section on the Company’s
website.
“We are pleased that Merck has begun the
submission process for Ebola candidate V920,” said Charles J. Link,
Jr, MD, Chairman and Chief Executive Officer. “Given the
recent outbreaks and recurrent risk Ebola poses to global public
health, we are encouraged by the potential for this vaccine to
address this deadly disease.”
About NewLink Genetics
Corporation
NewLink Genetics is a clinical stage
biopharmaceutical company focused on developing novel
immuno-oncology product candidates to improve the lives of patients
with cancer. NewLink Genetics' immunotherapeutic candidates,
indoximod and NLG802, a prodrug of indoximod, are investigational,
orally available small molecules targeting the IDO pathway and are
designed to harness multiple components of the immune system to
combat cancer. Indoximod reverses the immunosuppressive effects of
low tryptophan and high kynurenine through mechanisms that include
modulation of the AhR-driven transcription of genes that control
immune function. This results in increased proliferation of
effector T cells, increased differentiation into helper T cells
rather than regulatory T cells, and downregulation of IDO
expression in dendritic cells. Indoximod is being evaluated in
combination with treatment regimens including chemotherapy,
radiation, checkpoint blockade and cancer vaccines across multiple
indications including recurrent pediatric brain tumors, DIPG, and
AML. For more information, please
visit www.newlinkgenetics.com and follow us on Twitter
@NLNKGenetics.
Cautionary Note Regarding
Forward-Looking Statements
This press release contains forward-looking
statements of NewLink Genetics that involve substantial risks and
uncertainties. All statements contained in this press release are
forward-looking statements within the meaning of The Private
Securities Litigation Reform Act of 1995. The words "may," “appear
to,” “has potential to,” “look forward to,” or the negative of
these terms or other similar expressions are intended to identify
forward-looking statements, although not all forward-looking
statements contain these identifying words. These forward-looking
statements include, among others, statements about results of
NewLink’s clinical trials for product candidates, future financial
events, actions of our third party partners, and any other
statements other than statements of historical fact. Actual results
or events could differ materially from the plans, intentions and
expectations disclosed in the forward-looking statements that
NewLink Genetics makes due to a number of important factors,
including those risks discussed in "Risk Factors" and elsewhere in
NewLink Genetics' Annual Report on Form 10-K for the year ended
December 31, 2017 and other reports filed with the U.S. Securities
and Exchange Commission (SEC). The forward-looking statements in
this press release represent NewLink Genetics’ views as of the date
of this press release. NewLink Genetics anticipates that subsequent
events and developments will cause its views to change. However,
while it may elect to update these forward-looking statements at
some point in the future, it specifically disclaims any obligation
to do so. You should, therefore, not rely on these forward-looking
statements as representing NewLink Genetics' views as of any date
subsequent to the date of this press release.
Investor Contact & Media Contact:
Lisa MillerDirector of Investor RelationsNewLink
Genetics515-598-2555lmiller@linkp.com
Source: NewLink Genetics Corporation
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