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NewLink Genetics' IMPRESS Phase 3 Pancreatic Cancer Trial with Algenpantucel-L to Continue Following Second Interim Analysis

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® 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® 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.

CONTACT: Corporate Contact: Jack Henneman Chief Financial Officer, NewLink Genetics 515-598-2561 Investor@linkp.com Investors: Donna LaVoie LaVoieHealthScience 617-374-8800 dlavoie@lavoiehealthscience.com Media: David Connolly LaVoieHealthScience 617-374-8800 dconnolly@lavoiehealthscience.com

Source:NewLink Genetics Corporation