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NewLink Genetics to Present Poster on Indoximod, an IDO Pathway Inhibitor, at American Society of Clinical Oncology (ASCO) Annual Meeting

AMES, Iowa, May 26, 2015 (GLOBE NEWSWIRE) -- NewLink Genetics Corporation (Nasdaq:NLNK), a biopharmaceutical company focused on bringing novel immuno-oncology medicines to patients with cancer, today announced it is presenting a poster highlighting indoximod, an IDO (indoleamine-(2,3)-dioxygenase) pathway inhibitor, at the 2015 American Society of Clinical Oncology (ASCO) Annual Meeting in Chicago from May 29 through June 2.

NewLink Genetics is exhibiting a pipeline booth at the meeting with information on its HyperAcute® Immunotherapy and IDO Pathway Inhibitors programs. Please visit booth # 19159.

Details of the poster presentation:

Monday, June 1, 2015, 1:15 p.m. - 4:45 p.m. CDT
Title: A phase 1b/2 study of the combination of the IDO pathway inhibitor indoximod and temozolomide for adult patients with temozolomide-refractory primary malignant brain tumors: Safety analysis and preliminary efficacy of the phase 1b component. (Abstract #2070)
Presenter: Howard Colman, M.D., Director of Medical Neuro-Oncology at Huntsman Cancer Institute (HCI) at the University of Utah
Session: Central Nervous System Tumors
Location: S Hall A, Poster Board #59

About NewLink Genetics IDO Pathway Inhibitors

IDO pathway inhibitors are another class of immune check point inhibitors akin to the recently developed antibodies targeting CTLA-4, PD-1, and PD-L1 that represent potential breakthrough approaches to cancer therapy. The IDO pathway regulates immune response by suppressing T-cell activation which enables local tumor immune escape. Recent studies have demonstrated that the IDO pathway is active in many cancers, both within tumor cells as a direct defense against T-cell attack, and also within antigen presenting cells in tumor draining lymph nodes whereby this pathway promotes peripheral tolerance to tumor associated antigens (TAAs). When hijacked by developing cancers in this manner, the IDO pathway may facilitate the survival, growth, invasion and metastasis of malignant cells whose expression of TAAs might otherwise be recognized and attacked by the immune system. NewLink Genetics has a number of active programs directed at synthesizing inhibitors to the IDO pathway and additionally has discovered novel tryptophan-2,3-dioxygenase (TDO) specific inhibitors that are potential anti-cancer compounds which could function individually or in combination with IDO inhibition.

NewLink Genetics' proprietary IDO pathway inhibitor, indoximod, is in multiple Phase 1 and Phase 2 clinical trials for the treatment of patients with breast, prostate, pancreas, melanoma and brain cancers. In addition, NewLink Genetics entered into an exclusive worldwide license and collaboration agreement with Genentech, a member of the Roche Group, for the development of GNC-0919, which is currently in Phase 1 clinical development in patients with recurrent advanced solid tumors.

About HyperAcute Immunotherapy

NewLink's HyperAcute immune-oncology 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 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