NewLink Genetics Receives Notice of Allowance from USPTO Covering Indoximod Salts and Prodrugs
July 10 2017 - 7:00AM
NewLink Genetics Corporation (NASDAQ:NLNK) today announced that it
has received a Notice of Allowance for U.S. patent application
number 15/171,031 from the United States Patent and Trademark
Office (USPTO) covering claims to the salts and prodrugs of
indoximod (1-methyl-D-tryptophan). Indoximod is Newlink’s orally
bioavailable, small molecule targeting the IDO pathway with a
distinct mechanism of action.
“We are delighted to hear this positive news from the U.S.
patent office,” said Charles J. Link, Jr., M.D., Chief Executive
Officer of NewLink Genetics. “Indoximod continues to make
significant progress in the clinic with promising data across
multiple indications. This decision by the U.S. patent office
represents a key milestone in the alignment of indoximod’s global
patent strategy with our clinical development path.”
Upon issuance, the new patent will provide NewLink with
intellectual property protection covering the compounds and
pharmaceutical compositions comprised of salts and prodrugs of
indoximod.
“We believe indoximod’s promising clinical activity and
favorable safety profile, coupled with its differentiated mechanism
of action, position indoximod as a key molecule to be considered in
IO combinations,” said Nicholas Vahanian, M.D., Chief Medical
Officer of NewLink Genetics. “We are excited in our upcoming
pivotal trial in metastatic melanoma and allowances of these
patents align well with our strategy. Additionally, the preclinical
data we presented in April at the AACR Annual Meeting illustrated
how NLG802, which is our prodrug of indoximod and a new chemical
entity, increased the plasma concentrations of indoximod.”
This Notice of Allowance concludes the substantive examination
of our patent application and will result in the issuance of a U.S.
patent after administrative processes are completed. The U.S.
patent scheduled to issue from this application will expire in
2036.
About Indoximod
Indoximod is an investigational, orally available small molecule
targeting the IDO pathway. The IDO pathway is one of the key
immuno-oncology targets involved in regulating the tumor
microenvironment and immune escape.
NewLink Genetics is currently evaluating indoximod in multiple
combination studies for patients with various types of cancer
including melanoma, acute myeloid leukemia, pancreatic cancer and
prostate cancer.
About NLG802
NLG802 is an investigational, orally available prodrug of
indoximod, a small molecule targeting the IDO Pathway. The IDO
Pathway is one of the key immuno-oncology targets involved in
regulating the tumor microenvironment and immune escape.
NewLink Genetics will evaluate NLG802 in a Phase 1
dose-escalation clinical trial in cancer patients to assess the
safety and pharmacokinetics of NLG802.
About NewLink Genetics Corporation
NewLink Genetics is a late-stage biopharmaceutical company
focusing on discovering, developing and commercializing novel
immuno-oncology product candidates to improve the lives of patients
with cancer. NewLink Genetics' IDO pathway inhibitors are designed
to harness multiple components of the immune system to combat
cancer. Indoximod is being evaluated in combination with treatment
regimens including anti-PD-1 agents, cancer vaccines, and
chemotherapy across multiple indications such as melanoma, prostate
cancer, acute myeloid leukemia, and pancreatic cancer. For more
information, please visit http://www.newlinkgenetics.com.
Cautionary Note Regarding Forward-Looking
Statements
This press release contains forward-looking statements of
NewLink Genetics that involve substantial risks and
uncertainties. All statements, other than statements of
historical fact, contained in this press release are
forward-looking statements, within the meaning of The Private
Securities Litigation Reform Act of 1995. The words "anticipate,"
"believe," "estimate," "expect," "intend," "may," "plan," "target,"
"potential," "will," "could," "should," "seek" 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 any 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, 2016 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:
Lisa Miller
Director of Investor Relations
NewLink Genetics
515-598-2555
lmiller@linkp.com
Media:
Andrew Mastrangelo
AVP, Public & Media Relations
LaVoieHealthScience
617-374-8800, ext. 108
amastrangelo@lavoiehealthscience.com
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