Data from Clinical Study of NewLink Genetics’ IDO Pathway Inhibitor, Indoximod, to Be Presented at the 22nd European Hemato...
May 18 2017 - 6:00AM
NewLink Genetics Corporation (NASDAQ:NLNK) today announced that an
abstract describing data from a clinical study of its IDO pathway
inhibitor, indoximod, in combination with chemotherapeutic agents
for patients with newly diagnosed acute myelogenous leukemia (AML),
is now available on the website of the European Hematology
Association (EHA) Annual Congress.
An infographic accompanying this announcement is
available
at http://www.globenewswire.com/NewsRoom/AttachmentNg/8a3b562f-28b3-4526-baaf-95974cd8eb4f
“These data to be presented at the EHA Congress further
highlight clinical results presented at AACR in April and to be
presented at ASCO in June, supporting the hypothesis that the IDO
pathway is central to immune suppression in cancer,” said Charles
J. Link, Jr., M.D., Chief Executive Officer and Chief Scientific
Officer. “NewLink Genetics has two separate and distinct types of
IDO pathway inhibitors in clinical development. Indoximod, which is
wholly owned by NewLink Genetics, has a proposed differentiated
mechanism within the IDO pathway and acts as a tryptophan mimetic
having a direct effect on immune cells to reverse immune
suppression used by cancer to protect itself.”
Indoximod in combination with chemotherapeutic
agents
Initial results from the Phase 1b portion of a Phase
1b/randomized Phase 2a trial of indoximod in combination with
chemotherapeutic agents, idarubicin and cytarabine, for patients
with newly diagnosed AML will be presented as an e-poster (Abstract
number E-912) by Ashkan Emadi, M.D., Ph.D., Associate Professor of
the University of Maryland Greenebaum Comprehensive Cancer Center,
at EHA in Madrid on Friday, June 23, 2017, 9:30 AM to Saturday,
June 24, 7:00 PM CET and is titled: Indoximod in Combination with
Idarubicin and Cytarabine for Upfront Treatment of Patients with
Newly Diagnosed Acute Myeloid Leukemia (AML): Phase 1 Report.
This study uses a conventional remission induction and
consolidation protocol for patients with newly diagnosed AML.
Indoximod is given orally starting on day 8 of induction onward.
The Phase 1 portion evaluated three dose levels of indoximod (600
mg, 1000 mg, 1200 mg) in combination with the standard of care 7+3
chemotherapy. Twelve patients were enrolled, as of March 1, 2017.
The results indicate indoximod does not appear to add significant
toxicity to standard remission induction and consolidation therapy
for patients with newly diagnosed AML. Initial data suggest a low
rate of minimal residual disease (MRD-neg) after one cycle of
induction chemotherapy.
Nicholas N. Vahanian, M.D., President and Chief Medical Officer
added, “Importantly, these data support further clinical
investigation of our IDO pathway inhibitors in combination with
currently available therapies, such as chemotherapy for patients
with newly diagnosed Acute Myeloid Leukemia (AML).”
Key findings presented from the study include:
- Combination treatment with indoximod and conventional remission
induction and consolidation therapy was well tolerated without
adding significant toxicity
- Five of 6 (83%) evaluable patients treated with indoximod (600
mg or 1000 mg) achieved complete remission, with no evidence of
minimal residual disease
About IndoximodIndoximod 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 NewLink Genetics CorporationNewLink
Genetics is a biopharmaceutical company at the forefront of
discovering, developing and commercializing novel immuno-oncology
product candidates to improve the lives of patients with
cancer. NewLink Genetics' product candidates are designed
to harness multiple components of the immune system to combat
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:
Andrew Mastrangelo
AVP, Public & Media Relations
LaVoieHealthScience
617-374-8800, ext. 108
amastrangelo@lavoiehealthscience.com
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