NewLink Genetics Announces Final Results from Two Phase 2 Studies of Indoximod Presented at ASCO 2018
June 04 2018 - 2:15PM
Business Wire
NewLink Genetics Corporation (NASDAQ:NLNK) today announced that
data from two Phase 2 studies of indoximod, used in combination
with other agents, were presented at the 2018 American
Society of Clinical Oncology (ASCO) Annual Meeting.
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“Our data in advanced melanoma suggest that indoximod in
combination with checkpoint blockade shows encouraging response
rates potentially in both PD-L1 positive and negative patients,”
said Charles J. Link, Jr, MD, Chairman and Chief Executive Officer.
“We wish to thank the patients and their caregivers who
participated in both of these studies.”
Indoximod in combination with checkpoint inhibition in
advanced melanoma
Results from a single-arm Phase 2 study of indoximod in
combination with checkpoint inhibitors for patients with advanced
melanoma were presented today by Yousef Zakharia, MD, Assistant
Professor of Medicine, Division of Hematology, Oncology and
Blood & Marrow Transplantation at the University of
Iowa and Holden Comprehensive Cancer Center.
In this study, of 102 total patients enrolled, 101 patients with
advanced melanoma were treated with indoximod plus standard-of-care
checkpoint inhibition as approved for melanoma. 70 patients with
cutaneous or mucosal melanoma were treated with pembrolizumab plus
indoximod and had an on-treatment imaging, meeting the
per-protocol, pre-specified definition of evaluable for efficacy.
Of the remaining 32 patients, 15 had uveal melanoma, 4 received
ipilimumab, 4 received nivolumab, and one patient was never
treated. In addition, 8 patients came off study prior to the first
on-treatment imaging study. The full data set, including the
expanded biopsy cohort, is provided on the company’s website in the
“Posters & Presentations” section under the “Investors &
Media” tab.
Key findings from the 70 evaluable for efficacy patients
presented from the study include:
- ORR for combination therapy of 56%
- CR of 19%
- Median PFS of 12.4 months
- PD-L1 ≥ 1% staining of 54% (22/41
patients with archival tissue)
- ORR by PD-L1 status
- PD-L1 (+) patients: ORR of 77%
- PD-L1 (-) patients: ORR of 42%
- Combination was well tolerated
Indoximod in combination with chemotherapy in metastatic
pancreatic cancer
Results from a Phase 2 study of indoximod plus chemotherapy for
patients with metastatic pancreatic cancer were presented at ASCO
by Nathan Bahary, MD, PhD, Associate Professor in the Division of
Oncology and Medical Director of the Pancreatic Cancer Program at
the University of Pittsburgh Medical Center. Key findings from this
study show that the combination was well tolerated with a median
Overall Survival (mOS) of 10.9 months and an Overall Response Rate
(ORR) of 46.1%. Although the study did not meet the prespecified
primary goal of a 30% decrease in the risk of death compared with
historical controls, the combination demonstrated potentially
promising activity with an immunologic correlation for response to
therapy. These data may be found on the company’s website in the
“Posters & Presentations” section under the “Investors &
Media” tab.
About Indoximod
Indoximod is an investigational, orally available small molecule
targeting the IDO pathway. The IDO pathway is a key immuno-oncology
target involved in regulating the tumor microenvironment and immune
escape. Indoximod is being evaluated in combination with
treatment regimens including chemotherapy, radiation, checkpoint
blockade and cancer vaccines across multiple indications such as
AML, DIPG and melanoma.
About NewLink Genetics Corporation
NewLink Genetics is a clinical 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. 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 "guidance,"
"upcoming," "will," "plan," “intend,” "anticipate," "approximate,"
"expect," 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 NewLink Genetics' financial
guidance for 2018; results of its clinical trials for product
candidates; its timing of release of data from ongoing clinical
studies; its plans related to execution of clinical trials; plans
related to moving additional indications into clinical
development; NewLink Genetics' future financial
performance, results of operations, cash position and sufficiency
of capital resources to fund its operating requirements; 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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version on businesswire.com: https://www.businesswire.com/news/home/20180604005642/en/
Investor Contact:NewLink GeneticsLisa Miller,
515-598-2555Director of Investor Relationslmiller@linkp.comorMedia
Contact:LaVoieHealthScienceSharon Correia, 617-374-8800, ext.
105VP, Integrated
Communicationsscorreia@lavoiehealthscience.com
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