AMES, Iowa, May 11, 2015 (GLOBE NEWSWIRE) -- NewLink Genetics
Corporation (Nasdaq:NLNK), a biopharmaceutical company focused on
bringing novel immuno-oncology medicines to patients with cancer, today
announced the continuation without any modification or sample size
adjustment for its pivotal, Phase 3 IMmunotherapy for Pancreatic
RESectable cancer Study, called "IMPRESS," of algenpantucel-L for
patients with surgically resected pancreatic cancer following the
second planned interim data analysis.
"We look forward to bringing this study to its planned end point, as
algenpantucel-L has the potential to be the first and only FDA approved
drug for resected pancreatic cancer, providing additional treatment
options to patients, their families and physicians," said Nicholas N.
Vahanian, M.D., President and Chief Medical Officer of NewLink
Genetics.
IMPRESS is a multi-center, open-label clinical trial assessing the
safety and efficacy of algenpantucel-L, NewLink Genetics' HyperAcute(R)
Pancreatic Cancer immunotherapy candidate, conducted in more than 70
leading cancer centers. With 722 patients enrolled, IMPRESS is the
largest trial to be completed in the United States for patients with
resected pancreatic cancer. Algenpantucel-L has received fast-track
status and orphan drug designation from the U.S. Food and Drug
Administration (FDA). NewLink Genetics and the FDA reached agreement in
January 2010 on a Special Protocol Assessment (SPA) on the trial
design, clinical endpoints and statistical analyses plan for IMPRESS to
be used in support of a Biologic License Application (BLA).
"Our fast-track status, orphan drug designation and SPA give us
continued confidence in our regulatory strategy. With this in mind, we
are thoughtfully preparing for regulatory filings and commercial
activities associated with a potentially positive outcome of the
trial," said Charles Link, Jr., M.D., Chairman and Chief Executive
Officer. "There has been tremendous progress in oncology therapeutics,
but there have been only incremental improvements in overall survival
rates for pancreatic cancer. Our goal is that the result of the IMPRESS
study will contribute to the advancement of immunotherapy as a new
treatment option."
After careful consideration, including a series of communications with
the FDA regarding the statistical analysis plan, the Company decided to
retain the benefit of the SPA and not to change the statistical
analysis plan as defined in the original protocol. For the second
interim analysis, the independent data safety monitoring committee
(DSMC) reviewed available patient data with the originally planned
log-rank analysis and sample size recalculation, in all respects
consistent with the SPA. No other statistical methods were used. The
DSMC recommended the study proceed without any modifications, including
sample size adjustment, to final analysis. Therefore the Company
believes the trial remains powered to determine efficacy upon the
occurrence of 444 events.
The Company expects to provide further guidance regarding its
expectations for the IMPRESS trial and other clinical studies as well
as any update on financial guidance on its second quarter financial
results call in August.
About HyperAcute Immunotherapy
NewLink's HyperAcute(R) immunotherapy platform creates novel biologic
products that are designed to stimulate the human immune system to
recognize and attack cancer cells. HyperAcute product candidates are
composed of human cancer cells that are tumor specific, but not patient
specific. These cells have been modified to express alpha-gal, a
carbohydrate for which humans have pre-existing immunity. These
alpha-gal-modified cells stimulate a rapid and powerful human immune
response that trains the body's natural defenses to seek out and
destroy cancer cells. The objective of HyperAcute immunotherapies is to
elicit an antitumor response by "educating" the immune system to attack
a patient's own cancer cells. HyperAcute immunotherapies do not require
any tissue from individual patients and use intact whole cells rather
than cell fragments or purified proteins. We believe these unique
properties of HyperAcute products result in the stimulation of a robust
immune response.
NewLink's lead product candidate, algenpantucel-L (HyperAcute
pancreas), is being studied in a Phase 3 trial (IMPRESS: "Immunotherapy
for Pancreatic Resectable cancer Survival Study") under a Special
Protocol Assessment with the U.S. Food and Drug Administration. This
trial involves up to 722 patients with surgically resected pancreatic
cancer. Algenpantucel-L is also being tested in a second Phase 3 study
(PILLAR: "Pancreatic Immunotherapy with algenpantucel-L for Locally
Advanced non-Resectable"), involving patients with locally advanced
pancreatic cancer.
NewLink has several HyperAcute product candidates focused on other
tumor types in various stages of development, including
tergenpumatucel-L, which is in an adaptive design, randomized Phase 2b
clinical trial currently accruing up to 240 patients with non-small
cell lung cancer.
About Pancreatic Cancer
Pancreatic cancer is one of the most deadly types of cancer, with a
five year survival rate of only about seven percent. In 2015,
approximately 40,000 people died from pancreatic cancer in the U.S.
Each year, it is estimated that 240,000-270,000 people are diagnosed
with pancreatic cancer worldwide, with approximately 49,000 in the U.S.
There are few early symptoms of pancreatic cancer, and so it often is
not diagnosed until it is in advanced stages. Given this, only 10 to 20
percent of patients are eligible for surgical resection.
About NewLink Genetics Corporation
NewLink is a biopharmaceutical company focused on discovering,
developing and commercializing novel immuno-oncology products to
improve treatment options for patients with cancer. NewLink's portfolio
includes biologic and small molecule immunotherapy product candidates
intended to treat a wide range of oncology indications. NewLink's
product candidates are designed to harness multiple components of the
immune system to combat cancer without significant incremental
toxicity, either as a monotherapy or in combination with other
treatment regimens. For more information please visit
http://www.linkp.com.
Cautionary Note Regarding Forward-Looking Statements
This press release contains forward-looking statements of NewLink 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, among others, statements about our clinical trials for product
candidates and the timing of release of clinical data and other
information from ongoing clinical studies; 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, 2014, and in its other filings with the
Securities and Exchange Commission. 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.
