Phase 2, randomized, double-blind, placebo-controlled trial of
indoximod in combination with durvalumab, an immune checkpoint
inhibitor, along with gemcitabine/ABRAXANE®
(nab-paclitaxel) and durvalumab with gemcitabine/ABRAXANE®
AMES, Iowa--(BUSINESS WIRE)--
Genetics Corporation (Nasdaq: NLNK) today announced that it has
entered into a clinical collaboration agreement with AstraZeneca
to evaluate the combination of indoximod, NewLink Genetics' small
molecule IDO pathway inhibitor, and durvalumab, AstraZeneca's anti-PD-L1
monoclonal antibody, along with standard of care chemotherapy for
patients with metastatic pancreatic cancer.
The primary objective for this randomized placebo-controlled, Phase 2
study is to evaluate the efficacy and safety of the
immuno-oncology-based combination compared to gemcitabine/ABRAXANE
alone. Patients will also be enrolled into a smaller cohort evaluating
the combination of durvalumab with gemcitabine/ABRAXANE.
The Phase 2 trial will be funded equally by both companies, with NewLink
Genetics serving as the study sponsor. NewLink Genetics' share of the
aggregate expense of the trial is not expected to have a material effect
on its financial position.
"We are pleased to initiate a joint immuno-oncology clinical
collaboration with AstraZeneca," said Dr. Charles J. Link, Jr.,
Chairman, Chief Executive Officer and Chief Scientific Officer of
NewLink Genetics. "As recent data have indicated, indoximod combinations
with immunotherapy and chemotherapy show promise of improving outcomes
for patients with multiple tumor types."
(Imfinzi™), a human monoclonal antibody directed against PD-L1,
blocks PD-L1 interaction with PD-1 and CD80 on T cells, countering the
tumour's immune-evading tactics and inducing an immune response.
Durvalumab is being assessed in Phase III trials as a monotherapy in
various stages of NSCLC, in small-cell lung cancer (SCLC), in metastatic
urothelial cancer (mUC) and in head and neck squamous cell carcinoma
(HNSCC). The combination of durvalumab and tremelimumab is being
assessed in Phase III trials in NSCLC, SCLC, mUC and HNSCC and in Phase
I/II trials in hepatocellular carcinoma and haematological malignancies.
Imfinzi received accelerated approval from the US Food and Drug
Administration for previously treated patients with advanced bladder
cancer and is under review in Canada and Australia for similar use.
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 Metastatic (Stage IV) Pancreatic Cancer1
Approximately 53,670 new cases of pancreatic cancer in the US will be
diagnosed in 2017 according to the National Cancer Institute (NCI), and
a little over 43,000 people will die of the disease this year.
Pancreatic cancer is difficult to detect in its early stages. Because of
this, approximately 52% of all pancreatic cancers are metastatic, or
advanced, in nature and are associated with a poor prognosis. The 5-year
survival rate for pancreatic cancer overall is only 8.2%, and drops to a
low of 2.7% for individuals whose pancreatic cancer has metastasized to
farther regions of the body.
Cancer Institute: Pancreas Cancer
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/PD-L1 agents, cancer vaccines, and chemotherapy across
multiple indications such as melanoma, prostate cancer, acute myeloid
leukemia, and pancreatic cancer. For more information, please visit www.newlinkgenetics.com
and follow us on Twitter @NLNKGenetics.
IMFINZI™ is a registered trademark of AstraZeneca.
ABRAXANE® is a registered trademark of Celgene Corporation.
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.
View source version on businesswire.com: http://www.businesswire.com/news/home/20170925005299/en/
Lisa Miller, 515-598-2555
of Investor Relations
Mastrangelo, 617-374-8800, ext. 108
AVP, Public & Media Relations
Source: NewLink Genetics Corporation
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