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NewLink Genetics Presents Phase 1 Data Supporting Significantly Higher Exposure with Indoximod Prodrug

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NLG802, and Biomarker Data from Two Phase 2 Trials Illustrating Indoximods Impact on the Tumor Ames, Iowa, November 9, 2018 — NewLink Genetics Corporation (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 th and 10 th , from 8:00AM to 8:00PM ET. These posters with full data sets are provided on the companys website in the Posters & Presentations 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. Phase 1 Clinical Trial of NLG802, Indoximod Prodrug with Enhanced Pharmacokinetic Properties Preliminary data from a Phase 1a study 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 (P331). Co-author, Eugene Kennedy, MD, Chief Medical Officer, NewLink Genetics, will be present Friday, November 9 th , 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 rd , 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. …

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Source: US SEC
View full document: EX-991_of_8-K_for_NEWLINK_GENETICS_CORP__8-K-11-09-2018