NewLink Genetics Outlines 2018 Business Priorities to Support Phase 3 Pivotal Trial of Indoximod Plus PD-1 Inhibitors
January 08 2018 - 8:00AM
NewLink Genetics Corporation (NASDAQ:NLNK) today announced
Indigo301, the name of its upcoming Phase 3 trial of indoximod plus
PD-1 inhibitors for patients with advanced melanoma, and outlined
2018 business priorities to support this trial. In addition, the
company updated clinical and financial guidance and provided
preliminary unaudited financial information for year-end 2017.
These updates were made in conjunction with the 36th Annual JP
Morgan Healthcare Conference that begins today in San Francisco.
NewLink Genetics’ Chairman and Chief Executive Officer, Charles J.
Link, Jr., M.D., will discuss the Company’s continued execution of
its corporate strategy and 2018 priorities as part of a live
presentation on Thursday, January 11, 2018, at 11:00 AM PT/2:00 PM
ET. The slide presentation with updated guidance has been posted on
the Company’s website and may be found here. The oral presentation
will be webcast and available on the NewLink Genetics website under
the Investors & Media tab under Events & Presentations.
Indigo301 is a randomized Phase 3 study of indoximod or placebo
plus KEYTRUDA® (pembrolizumab) or OPDIVO® (nivolumab) for patients
with unresectable or metastatic melanoma. The choice of PD-1
inhibitors will be at the physician’s discretion, mirroring the
general clinical setting. The study will consist of a planned 624
patients enrolled at approximately 100 sites in multiple countries
and will include co-primary endpoints of Progression-Free Survival
(PFS) and Overall Survival (OS), with a secondary endpoint of
Objective Response Rate (ORR).
“NewLink has focused its business priorities on the execution of
Indigo301 for patients with advanced melanoma,” said Dr. Link. “We
will also initiate a randomized Phase 2 trial in collaboration with
AstraZeneca for patients with metastatic pancreatic cancer, and we
anticipate clinical data from additional development programs.”
To expedite the enrollment of Indigo301, NewLink Genetics has
expanded the planned number of trial sites both within and outside
of the US and plans several clinical recruitment initiatives to
engage with the oncology community with the goal to enroll the
majority of patients in 2018. As a result of these clinical
planning efforts, NewLink Genetics is accordingly updating its
guidance for clinical trials as follows:
Clinical Guidance and Milestones
- Enroll the majority of Indigo301 trial by the end of 2018
- Phase 2 results for indoximod + PD-1 blockade in advanced
melanoma expected in 2018
- Phase 2 results for indoximod + gem/nab-paclitaxel in
pancreatic cancer expected 1H 2018
- Phase 2 randomized AstraZeneca collaboration in pancreatic
cancer to initiate 1H 2018
Financial Guidance and Outlook
“Entering 2018, we have aligned our business and investments to
drive Indigo301 and other high-potential development programs,”
said Jack Henneman, Executive Vice President and Chief Financial
Officer for NewLink Genetics. “As we continue to progress, we
remain committed to maintaining the strength of our balance sheet
in support of our most promising clinical programs.”
NewLink Genetics ended 2017 with approximately $158 million in
cash and cash equivalents. Updated guidance for use of cash is
provided in the slide presentation available on the company’s
website.
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. NewLink Genetics is
currently evaluating indoximod in multiple combination studies for
patients with various types of cancer including melanoma,
pancreatic cancer and other malignancies.
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, pancreatic cancer and other
malignancies. For more information, please visit
www.newlinkgenetics.com and follow us on Twitter @NLNKGenetics.
KEYTRUDA® is a registered trademark of Merck, Sharp & Dohme
Corp., a subsidiary of Merck & Co., Inc.
OPDIVO® is a registered trademark of Bristol-Myers Squibb
Company.
Cautionary Note Regarding
Forward-Looking Statements
This press release contains forward-looking statements of
NewLink 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,” "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 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 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's views as of the date of this press release. NewLink
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 MillerDirector of Investor
Relations NewLink Genetics515-598-2555lmiller@linkp.com
Media Contact:Vivian NiPublic & Media
RelationsLaVoieHealthScience617-374-8800, ext.
109vni@lavoiehealthscience.com
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