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NewLink Genetics Presents Encouraging Updated Phase 1 Data with Indoximod Plus Chemotherapy in Frontline AML in an Oral Session at 2018 ASH Annual Meeting

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  • Updated Phase 1 data for indoximod plus standard-of-care
    chemotherapy in newly diagnosed AML show post-induction minimal
    residual disease (MRD) negativity rate of 86% and post-consolidation
    MRD negativity of 100%
  • Safety data from this study indicate the combination treatment
    regimen was well tolerated with no regimen limiting toxicities (RLTs)
    observed

NewLink
Genetics Corporation
(NASDAQ:NLNK) announced that updated Phase 1 data evaluating
indoximod plus standard-of-care chemotherapy for the treatment of adult
patients with newly diagnosed acute myeloid leukemia (AML) were
presented today by Ashkan Emadi, MD, PhD, Professor of Medicine and
Associate Director for Clinical Research, University
of Maryland Greenebaum Comprehensive Cancer Center
, in an oral
session today at the 60th American Society of Hematology (ASH)
Annual Meeting in San Diego, CA, from 9:30AM – 11:00AM PT, in Grand Hall
B, Manchester Grand Hyatt.

This press release features multimedia. View the full release here:
https://www.businesswire.com/news/home/20181202005047/en/

Indoximod plus Chemotherapy in Acute Myeloid Leukemia (AML) (Graphic: Business Wire)

Indoximod plus Chemotherapy in Acute Myeloid Leukemia (AML) (Graphic: Business Wire)

This Phase 1 trial evaluated the initial safety and preliminary evidence
of clinical activity of adding indoximod to standard 7+3 induction and
high-dose cytarabine (HiDAC) consolidation chemotherapy for adult
patients with newly diagnosed AML. The presentation highlighted an
initial safety profile indicating that the treatment regimen was well
tolerated with adverse events commensurate with chemotherapy alone.
Evidence of clinical activity was observed for indoximod plus
chemotherapy in newly diagnosed AML as supported by these Phase 1 data
showing post-induction minimal residual disease (MRD) negativity rate of
86% and post-HiDAC1 MRD negativity of 100%.

"These data demonstrate the promising potential for indoximod in
combination therapy for patients with newly diagnosed AML and the use of
MRD status as a study endpoint," said Dr. Ashkan Emadi. "We remain
encouraged and look forward to additional data as this study proceeds."

Fifty-seven patients were screened, and 38 patients initiated induction
therapy on protocol. Five patients never received indoximod resulting in
an intent-to-treat (ITT) population of 33 patients. Twenty-two patients
received the pre-specified 80% of indoximod dosing required to be
included in the per protocol (PP) analysis, 8 received less than 80% of
the scheduled indoximod dosage, and 3 patients remained on induction
treatment as of the date of data cut off. Of these 22 PP patients, 16/22
(73%) achieved complete morphological response (CR) and 6 were primary
refractory. Of the patients who achieved CR, 14 had results available
from MRD testing post-induction. MRD negativity was defined by a flow
cytometry assay at a level of < 0.02% (Hematologics, Inc., Seattle, WA).
Of those tested, 12/14 (86%) were MRD-negative. Of the 14 patients, 1
patient proceeded to transplant, and 13 began HiDAC consolidation
therapy. Post-HiDAC consolidation, all 13 patients were tested for MRD
status with all 13/13 (100%) reported to be MRD-negative. When
benchmarked against available published studies, these initial data
appear encouraging. For a more precise comparison, a contemporaneous
multi-institutional dataset is being aggregated to benchmark these data
against data generated from patients undergoing the same chemotherapy
regimen without the addition of indoximod using the same MRD assay
assessed at the same reference laboratory.

Safety data from this Phase 1 trial indicate that the combination
therapy regimen was well tolerated. No RLTs were observed when combining
indoximod with standard-of-care chemotherapy. Grade 3 or greater adverse
hematologic events included febrile neutropenia, anemia, and
thrombocytopenia while non-hematologic events included hypoxia, anemia,
and pneumonia. The overall adverse event profile observed in this small
sample size is consistent with that of 7+3 induction chemotherapy plus
HiDAC consolidation alone.

About AML1,2

Adult acute myeloid leukemia (AML) is a cancer of the blood and bone
marrow in which the bone marrow makes abnormal types of white blood
cells, red blood cells, or platelets. AML is the most common type of
acute leukemia in adults and tends to progress rapidly without
treatment. In the US, approximately 19,000 patients per year are
diagnosed with AML with only around 25% expected to survive longer than
three years. Of those newly diagnosed patients, approximately half are
categorized as young and fit for an aggressive chemotherapy treatment
regimen.

1 National Cancer Institute
2 American
Society of Clinical Oncology

About Indoximod

Indoximod is an investigational, orally available small molecule
targeting the IDO pathway. The IDO pathway is a key immuno-oncology
target, suppressing immune response and allowing for immune escape by
degrading tryptophan with the resultant production of kynurenine.
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.

About NewLink Genetics Corporation

NewLink Genetics is a clinical stage biopharmaceutical company focusing
on developing 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. 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 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.

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