AMES, Iowa--(BUSINESS WIRE)--NewLink Genetics Corporation (NASDAQ:NLNK), reported that updated Phase 1 data evaluating indoximod plus front-line radiation and maintenance chemotherapy for the treatment of pediatric patients with newly diagnosed diffuse intrinsic pontine glioma (DIPG) were presented Sunday, July 1, at the International Symposium of Pediatric Neuro-Oncology (ISPNO) 2018 Annual Meeting in Denver.
Data were presented on ten newly diagnosed DIPG patients, all of whom had initiated therapy at the time of this assessment. All (10/10) demonstrated initial symptomatic improvement. Eight of ten had completed radiation, with the remaining 2 of 10 patients continuing radiotherapy. While a subset of the patient cohort developed inflammatory and other adverse symptomology, a common occurrence in this patient population, these symptoms were actively managed. Currently, 9/10 patients remain on study, with the longest time on study of 8.5 months. These data include more mature follow-up on the 6 patients previously presented at AACR 2018.
“These data continue to demonstrate the potential for indoximod plus radiochemotherapy as a combination treatment regimen which may improve disease related symptoms for these pediatric patients with an otherwise dire prognosis,” said Dr. Theodore S. Johnson, M.D., Ph.D., Associate Professor of Pediatrics at Augusta University, lead investigator for the trial. “We remain encouraged and look forward to additional data as the study proceeds.”
This DIPG cohort is a subset of NLG2105, a Phase 1 study evaluating indoximod, NewLink’s IDO pathway inhibitor, in combination with radiation and chemotherapy for pediatric patients with malignant brain tumors. The DIPG cohort has been expanded from an initial pilot study based on early safety and efficacy data and is currently enrolling with a target of 30 DIPG patients.
About Diffuse Intrinsic Pontine Glioma (DIPG)
Diffuse intrinsic pontine glioma, or DIPG, is a rare, aggressive brain tumor found in the brain stem that almost exclusively affects children. Every year in the United States, approximately 200-400 children, ages ranging from 4 to 11, are diagnosed with DIPG. As the tumor grows, it puts pressure on the nerves that control essential bodily functions. Children experience symptoms including, but not limited to: vision issues, arm and leg weakness and difficulty speaking, breathing and heartbeat resulting in death. The median survival time is 9 months, with only 1% of all children diagnosed with DIPG surviving more than 5 years.1
1 Defeat DIPG Foundation
About Indoximod
Indoximod is an investigational, orally available small molecule targeting the IDO pathway. The IDO pathway is a key immuno-oncology target involved in regulating the tumor microenvironment and immune escape. Indoximod is being evaluated in combination with treatment regimens including chemotherapy, radiation, checkpoint blockade and cancer vaccines across multiple indications such as AML, DIPG and melanoma.
About NewLink Genetics Corporation
NewLink Genetics is a clinical stage biopharmaceutical company focusing on discovering, developing and commercializing 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 www.newlinkgenetics.com and follow us on Twitter @NLNKGenetics.
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