NewLink Genetics Presents Phase 1b Data of Indoximod in Combination With Gemcitabine/Nab-Paclitaxel

NewLink Genetics Corporation

, a biopharmaceutical company at the forefront of discovering, developing and commercializing novel immuno-oncology product candidates, including both cellular immunotherapy and checkpoint inhibitor platforms, today announce the presentation of data that describe a combination therapy of indoximod, an IDO pathway inhibitor, plus gemcitabine/nab-paclitaxel, for patients with metastatic pancreatic cancer. This combination immunotherapeutic approach was well tolerated and shows encouraging durable responses with a delayed pattern and a 42 percent objective response rate, including one complete response (CR), according to data presented at the 2016 Gastrointestinal Cancers Symposium (ASCO GI) in San Francisco. "The preliminary overall response rate is certainly promising, but I am particularly intrigued by the pattern of delayed and durable responses potentially suggesting an immune mediated mechanism of action," said Nathan Bahary, MD, PhD, Associate Professor in the Division of Oncology and Medical Director of the Pancreatic Cancer Program at the University of Pittsburgh Medical Center, and principal investigator of the study. These data come from the Phase 1b portion of the trial that included 12 patients who were evaluable for a response. To date, this Phase 1/2 trial has enrolled 50 patients, with a target enrollment of 80 patients in the Phase 2 portion. In the Phase 1b portion of the trial, the combination therapy with indoximod had an objective response rate of 42 percent (5/12), including one CR. The MPACT study, which established gemcitabine/nab-paclitaxel as standard of care for patients with metastatic pancreatic cancer, demonstrated an objective response rate of 23 percent. "Pancreatic cancer continues to be one of the deadliest of all malignancies with very limited options for the patients. I am delighted to be part of this study with gemcitabine/nab-paclitaxel in combination with the immunomodulatory agent indoximod, targeting the IDO pathway, as this combination approach seems to offer a potential benefit with minimal added toxicity," said Andrea Wang-Gillam, MD, PhD, Associate Professor of Medicine in the Division of Oncology at Washington University School of Medicine in St. Louis. These data are being presented today at ASCO GI, during Poster Session B (12:30-2:00PM and 5:30-7:00PM), "Cancers of the Pancreas, Small Bowel, and Hepatobiliary Tract," correspond to abstract number 452 entitled, "Results of the Phase 1b Portion of a Phase 1/2 trial of the Indoleamine 2,3-dioxygenase Pathway (IDO) Inhibitor Indoximod plus Gemcitabine/Nab-Paclitaxel for the Treatment of Metastatic Pancreas Cancer."