NewLink Genetics Shares Its Immuno-Oncology Strategy 2016 Analyst and Investor Day
October 25 2016 - 4:05PM
Two Distinct IDO Pathway Inhibitors in
Clinical Development
NewLink Genetics Corporation (Nasdaq:NLNK), a biopharmaceutical
company focused on bringing novel immuno-oncology therapies to
patients with cancer, today shared its strategy for becoming a
leading immuno-oncology company at the company’s 2016 meeting for
analysts and investors in New York City.
The program focused on the science and
increasing validation of the IDO pathway as a target for oncology
drug candidates and NewLink Genetics’ clinical programs. A link to
a replay of the webcast and the slides can be accessed in the
events tab of the investor and media relations section of the
company's website, http://investors.linkp.com/events.cfm.
"With data presentations from recent oncology
medical meetings, there is a lot of excitement and promise in IDO
as an important target. IDO pathway inhibitors are natural
potential partners for combination treatments with other
immuno-oncology checkpoint inhibitors and chemotherapies. We are
excited to have two of the five IDO product candidates in clinical
development now,” said Charles J. Link, Jr., M.D., Chairman and
Chief Executive Officer. “One is indoximod, which is our
proprietary IDO pathway inhibitor, and the other is GDC-0919, which
is partnered with Genentech, a member of the Roche Group.”
Leaders in the field of immuno-oncology who
presented at today’s meeting include: George C. Prendergast, PhD,
President & CEO, Lankenau Institute for Medical Research (LIMR)
and Editor in Chief, Cancer Research; David H. Munn, MD, Professor
of Pediatric Hematology-Oncology, Medical College of Georgia
Augusta University; Montaser Shaheen MD, Associate Professor,
University of New Mexico Cancer Center; and Ashkan Emadi, MD, PhD,
Associate Professor, University of Maryland.
Key takeaways include:
- Validation of IDO as a Target. The IDO pathway
can allow cancer to escape the immune system. Many cancers have
developed the ability to employ IDO to evade immune attack.
Clinical results are increasingly validating the IDO pathway as a
target for cancer therapies. Just as scientists discovered the role
of PD-1/PD-L1 expression and the usefulness of PD-1/PD-L1 blockade,
there is an increasing body of research into the role of the IDO
pathway and the potential for its inhibition.
- NewLink’s Two IDO Pathway Inhibitor Clinical
Candidates. NewLink Genetics is engaged in clinical trials
for two IDO pathway inhibitor product candidates, with two distinct
mechanisms of action.• GDC-0919, a direct IDO
enzyme inhibitor, is being developed in partnership with Genentech.
GDC-0919 is currently in Phase 1b trials, in combination with
atezolizumab in solid tumors. In October, 2014, NewLink and
Genentech entered in to a license and collaboration agreement with
an upfront payment of $150 million, more than $1 billion in
potential milestones and substantial royalties.•
Indoximod, an IDO pathway inhibitor, is proprietary to
NewLink Genetics. Indoximod is in the clinic addressing multiple
cancers including melanoma, pancreatic, glioblastoma multiforme,
breast, acute myeloid leukemia and non-small cell lung.
- Indoximod Clinical Development.
Our clinical development strategy for indoximod
includes formulation optimization intended to improve the
candidate’s commercial and clinical potential. The Company
reported that it will evaluate the data and report on several
clinical trials underway in 2017.
- Future R&D. NewLink also
discussed its program targeting the PTEN pathway in regulatory T
cells (Treg cells) as a central driver of tumor immunosuppression.
NewLink Genetics is an early leader in the field of PTEN research
just as it was in identifying IDO as a potential pathway for immune
suppression.
Nicholas N. Vahanian, MD, Co-founder, President
& Chief Medical Officer added, “We have built a strong
management team, comprised of scientific, clinical and business
leaders, with proven expertise in drug discovery and clinical
development.”
Dr. Vahanian continued, “With the early clinical
results in IDO inhibition from NewLink Genetics and our partner,
Genentech, we are very well positioned to execute our strategy in
taking these immuno-oncology clinical programs forward.
Further, we have a strong balance sheet which supports the
execution of our clinical plan.”
About NewLink Genetics Corporation
NewLink 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' portfolio includes biologic
and small molecule immunotherapy product candidates intended to
treat a wide range of oncology indications. 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
Statements
This press release contains forward-looking
statements of NewLink Genetics that involve substantial risks and
uncertainties. All statements, other than statements of historical
facts, 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, 2015 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.
Contact:
Jack Henneman
EVP, CFO
NewLink Genetics
(515) 598-2561
Investor@linkp.com
Investor and Media Contacts:
Beth Kurth, VP
LaVoieHealthScience
617-374-8800 X106
bkurth@lavoiehealthscience.com
Ben Navon, AVP
LaVoieHealthScience
617-374-8800 X108
bnavon@lavoiehealthscience.com
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