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.