NewLink Genetics Presents Phase 1 Data Supporting Significantly Higher Exposure with Indoximod Prodrug, NLG802, and Biomarker Data from Two Phase 2 Trials Illustrating Indoximod’s Impact on the Tumor Microenvironment at SITC 2018

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AMES, Iowa, Nov. 09, 2018 (GLOBE NEWSWIRE) -- (NASDAQ:NLNK) announced that data from three separate trials are being presented at the Society for Immunotherapy of Cancer (SITC) Annual Meeting in Washington D.C. Data from a Phase 1a clinical trial of NLG802, a prodrug of indoximod, as well as biomarker data from two Phase 2 studies of indoximod in combination therapy are being presented in poster sessions today and tomorrow, November 9 and 10, from 8:00AM to 8:00PM ET. These posters with full data sets are provided on the company’s website in the “” section under the “Investors & Media” tab.

“We are delighted to be able to present these data supporting both activity of indoximod within the tumor microenvironment and the higher exposure levels obtained by indoximod prodrug, NLG802, supporting the potential for these drugs to elicit therapeutic responses and improve the lives of patients with cancer,” said Charles J. Link, Jr, MD, Chairman and Chief Executive Officer.

Preliminary data from a Phase 1a of NLG802, a prodrug of indoximod, are being presented today by Olivier Rixe, MD, PhD, Professor of Medicine, University of New Mexico Comprehensive Cancer Center, Albuquerque, NM in a poster session (). Co-author, Eugene Kennedy, MD, Chief Medical Officer, NewLink Genetics, will be present Friday, November 9, 12:45-2:15PM and 6:30-8:00PM, to discuss these data. 

NLG802 is being evaluated in an ongoing standard 3+3 dose escalation Phase 1a study in patients with recurrent advanced solid malignancies. The purpose of this trial is to assess the safety, maximum tolerated dose, and pharmacokinetic properties of this drug candidate.  As of October 3, the cutoff date for these data, 11 patients were enrolled in this study in three separate dose cohorts, 180 mg BID, 363 mg BID, and 726 mg BID. 

Key findings from these preliminary data:

Biopsy data from a Phase 2 of indoximod plus checkpoint inhibition from patients with advanced melanoma are being presented today by Jiayi Yu, PhD, Senior Scientist, NewLink Genetics, in a poster session (). The author will be present Saturday, November 10, 12:20-1:50PM and 7:00-8:30PM to discuss these data.

In this study, patients with unresectable advanced melanoma underwent pretreatment tumor biopsy followed by a repeat biopsy after cycle 3 of indoximod plus pembrolizumab.  Fourteen pairs of tumor specimens (6 patients with objective response and 8 non-responders) underwent RNA sequencing analysis and immunofluorescence staining to assess immune activity in the tumor microenvironment (TME), to define changes in the tumor genomic profile and gene expression.  Baseline samples from the trial were used for predictive biomarker assessment (N = 38). 

Key findings from these biopsy data:

Previously published from this Phase 2 study of indoximod plus pembrolizumab for patients with advanced melanoma may be found on the company’s website under “” in the “Investors & Media” section.

Biopsy data from a Phase 2 of indoximod plus chemotherapy for patients with metastatic pancreatic cancer are being presented today by Jiayi Yu, PhD, Senior Scientist, NewLink Genetics, in a poster session ().  Co-author, Gabriela Rossi, PhD, Vice President, Biologics Development, NewLink Genetics, will be present Saturday, November 10, 12:20-1:50PM and 7:00-8:30PM to discuss these data.

In this study, treatment-naïve patients with metastatic pancreatic cancer underwent pre-treatment tumor biopsy with a repeat biopsy on week 8. Sixteen pairs of tumor specimens (8 patients with objective response, and 8 non-responders) underwent RNA sequencing analysis and immunohistochemistry (IHC) staining to assess immune activity in the tumor microenvironment.

Key findings from these biopsy data indicate that indoximod plus standard-of-care (SOC) chemotherapy:

Previously published from this Phase 2 study of indoximod plus gemcitabine/nab-paclitaxel for patients with metastatic pancreatic cancer may be found on the company’s website under “” in the “Investors & Media” section.

Indoximod is an investigational, orally available small molecule targeting the IDO pathway. The IDO pathway is a key immuno-oncology target, suppressing immune response and allowing for immune escape by degrading tryptophan with the resultant production of kynurenine.  Indoximod reverses the immunosuppressive effects of low tryptophan and high kynurenine through mechanisms that include modulation of the AhR-driven transcription of genes that control immune function.  This results in increased proliferation of effector T cells, increased differentiation into helper T cells rather than regulatory T cells, and downregulation of IDO expression in dendritic cells. Indoximod is being evaluated in combination with treatment regimens including chemotherapy, radiation, checkpoint blockade and cancer vaccines across multiple indications including recurrent pediatric brain tumors, DIPG, and AML.

NLG802 is a prodrug of indoximod. NLG802 has been shown in preclinical trials to increase bioavailability and exposure to indoximod above the levels achievable by direct administration of indoximod. NLG802 is currently being evaluated in clinical trials. 

NewLink Genetics is a clinical stage biopharmaceutical company focusing on developing novel immuno-oncology product candidates to improve the lives of patients with cancer. NewLink Genetics' IDO pathway inhibitors are designed to harness multiple components of the immune system to combat cancer. For more information, please visit and follow us on Twitter .

Investor & Media Contact:

Lisa MillerDirector of Investor RelationsNewLink Genetics515-598-2555

More news and information about NewLink Genetics Corporation

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Globe Newswire: 13:00 GMT Friday 9th November 2018

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