NewLink Genetics Corporation (NASDAQ:NLNK) today announced that
abstracts from two clinical studies of its IDO pathway inhibitors,
indoximod and navoximod (GDC-0919), used in combination with other
agents, are now available on the website of the 2017 American
Society of Clinical Oncology (ASCO) Annual Meeting.
An infographic accompanying this announcement is available
at http://www.globenewswire.com/NewsRoom/AttachmentNg/b945495b-6286-4184-881f-b4ea49aa46b4
“The IDO pathway is a key immuno-oncology target and NewLink
Genetics has two separate and distinct IDO pathway inhibitors in
clinical development. Indoximod, which is wholly owned by
NewLink Genetics, has a proposed differentiated mechanism within
the IDO pathway and acts as a tryptophan mimetic having a direct
effect on immune cells to reverse immune suppression used by cancer
to protect itself. Navoximod is our direct enzymatic inhibitor of
IDO and is partnered with Genentech/Roche,” said Charles J. Link,
Jr., M.D., Chief Executive Officer and Chief Scientific Officer of
NewLink Genetics.
Indoximod in combination with the therapeutic cancer
vaccine, PROVENGE®
Results from a randomized, double-blind, placebo-controlled,
multi-institutional Phase 2 investigator initiated study with
indoximod in combination with the therapeutic cancer vaccine,
PROVENGE® (sipuleucel-T), for patients with metastatic castration
resistant prostate cancer will be presented as a poster (Abstract
number 3066) by Gautam Gopalji Jha, M.D., Adjunct Assistant
Professor, Division of Hematology and Oncology, University of
Minnesota, at ASCO in Chicago on Monday, June 5, 2017, 8:00 a.m. –
11:30 a.m. CT, titled, A phase 2 randomized, double-blind study of
sipuleucel-T followed by IDO pathway inhibitor, indoximod or
placebo in the treatment of patients with metastatic castration
resistant prostate cancer (mCRPC).
In the study, forty-six patients were randomized into two arms
to receive either twice daily oral indoximod (n=22) or placebo
(n=24) for 6 months beginning the day after the third and final
PROVENGE infusion. Conclusions indicate that treatment with the IDO
pathway inhibitor, indoximod, post PROVENGE therapy, leads to
significant improvement in radiographic progression free survival
(rPFS) when compared to placebo and is well-tolerated.
Key findings presented from the study include:
- Statistically significant improvement in median rPFS was 10.3
months in the treatment arm compared to 4.1 months in the placebo
arm (p = 0.011)
- Median Overall Survival (OS) has not yet been reached
- Patients tolerated therapy with indoximod with no significant
differences in adverse events between the two arms
- There was no statistical difference in the primary endpoint of
ELISPOT assay immune response to PA2024, the PROVENGE-related
fusion protein, in the 35 of 46 patients who had clinical samples
available for testing
“These data further support the hypothesis that targeting the
IDO Pathway in combination with a broad backbone of treatment
regimens including chemotherapy, anti-PD-1 antibodies and
therapeutic vaccines across multiple indications has the potential
to provide meaningful clinical benefit without compromising
tolerability,” commented Nicholas N. Vahanian, M.D., President and
Chief Medical Officer of NewLink Genetics.
Navoximod in combination with TECENTRIQ®
(atezolizumab) in multiple solid
tumors
Initial data from a Phase 1b dose-escalation study of navoximod
in combination with TECENTRIQ® for patients with locally advanced
or metastatic solid tumors conducted by our partner,
Genentech/Roche, will be presented in an oral presentation
(Abstract number 105) by Howard A. “Skip” Burris, III, M.D.,
President Clinical Operations and Chief Medical Officer, Sarah
Cannon Research Institute, at ASCO in Chicago on Sunday, June 4,
2017, 10:24 a.m. CT. The presentation is titled, A phase 1b
dose-escalation study of combined inhibition of IDO1 (GDC-0919) and
PD-L1 (atezolizumab) in patients with locally advanced or
metastatic solid tumors.
This Phase 1b, open-label, dose-escalation study is designed to
characterize safety and tolerability. Secondary objectives
include identifying a maximum tolerated dose (MTD) and recommended
Phase 2 dose, and evaluating pharmacokinetics, pharmacodynamics,
and anti-tumor activity. Patients were given TECENTRIQ (1200 mg IV
every 3 weeks) and escalating doses of navoximod (orally twice
daily, for 21 days) using a standard 3+3 design. Initial results
from this study (n=52, non-selected heterogeneous population during
the dose escalation) found the combination was generally
well-tolerated, with peripheral IDO1 modulation, and some early
activity signals. Patients were previously treated with prior
systemic therapies with a median number of 3 and a range of 1-9.
Two patients also received prior immunotherapy.
The design of the trial includes the initial dose-escalation
phase reported in this abstract, followed by disease-specific
expansion cohorts (enrollment target is 305 patients) for patients
with select tumor types including non-small-cell lung cancer
(NSCLC), renal cell cancer (RCC), urothelial bladder cancer (UBC),
triple negative breast cancer (TNBC), to further evaluate safety,
response, and peripheral and tumor pharmacodynamics. Updates for
this study will continue to be reported by Genentech/Roche.
Dr. Vahanian continued, “We are encouraged by the clinical
profile for the combination of navoximod and atezolizumab from the
first phase of this combination trial and look forward to the data
for the disease-specific expansion cohorts which are currently
accruing patients.”
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' product candidates are
designed to harness multiple components of the immune system to
combat cancer. For more information, please visit
http://www.newlinkgenetics.com.
PROVENGE® is a registered trademark of Dendreon/Valeant
Pharmaceuticals International, Inc. TECENTRIQ® is a
registered trademark of Genentech, Inc.
Cautionary Note Regarding Forward-Looking
StatementsThis 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, among others, statements about
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; 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, 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.
Investor Contact:
Lisa Miller
Director of Investor Relations, NewLink Genetics
515-598-2555
lmiller@linkp.com
Media:
Andrew Mastrangelo
AVP, Public & Media Relations
LaVoieHealthScience
617-374-8800, ext. 108
amastrangelo@lavoiehealthscience.com
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