Positive Phase 1b Data for NewLink Genetics’ IDO Pathway Inhibitor, Indoximod, in Combination with Chemotherapy for Patient...
23 June 2017 - 9:00PM
NewLink Genetics Corporation (NASDAQ:NLNK) today announced the
presentation of data from the Phase 1b portion of a study of
indoximod, an IDO pathway inhibitor, in combination with idarubicin
and cytarabine for patients with newly diagnosed acute myeloid
leukemia (AML). Abstract E-912, Indoximod in Combination with
Idarubicin and Cytarabine for Upfront Treatment of Patients with
Newly Diagnosed Acute Myeloid Leukemia (AML): Phase 1 Report, is
being presented by Ashkan Emadi, M.D., Ph.D., Associate
Professor of Medicine at the University of Maryland Greenebaum
Comprehensive Cancer Center, during the European Hematology
Association (EHA) Congress in Madrid, Spain on Friday, June 23,
2017, 9:30 AM to Saturday, June 24, 7:00 PM CET.
These data indicate indoximod does not appear to add significant
toxicity to standard therapy for patients with newly diagnosed AML,
and no regimen-limiting toxicities (RLT) have been observed to
date. Initial data show that the morphological complete remission
(CR) rate is as expected after one cycle of induction
chemotherapy. Seven of seven patients who achieved CR were
found to have no minimal residual disease (MRD-neg).
“While from a small number of patients, these data show an
encouraging MRD negativity rate and may offer the potential for
measurable clinical benefits for patients,” said Dr. Emadi,
Principal Investigator of this study.
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.
About NewLink Genetics CorporationNewLink
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
StatementsThis 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, among others, statements about
results of its clinical trials for product candidates; its timing
of release of data from ongoing clinical studies; its plans related
to moving additional indications into clinical development; 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, 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:
Sharon Correia
VP, Integrated Communications
LaVoieHealthScience
617-374-8800, ext. 105
scorreia@lavoiehealthscience.com
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