NewLink Genetics Announces Promising Clinical Data at ECC 2015

NewLink Genetics Corporation 

announced promising early-stage clinical data from a phase 1a study of GDC-0919, an IDO checkpoint inhibitor being developed in collaboration with Genentech, a member of the Roche Group

, was presented today at the European Cancer Congress 2015 (ECC) in Vienna, Austria. The data reported today are from a Phase 1a study of the safety, pharmacokinetics and pharmacodynamics of GDC-0919 in 19 patients with recurrent or advanced solid tumors. The primary objectives of this study are to evaluate the safety and tolerability of GDC-0919 in patients with advanced solid tumors as well as to define the maximum tolerated dose (MTD) or maximum biologically effective dose and recommended Phase 2 dose. GDC-0919, a small molecule investigational immunotherapy designed to inhibit IDO1 for the treatment of immune tolerance associated with cancer, is intended as a combination therapy with other immunotherapies and oncology therapeutics. The data showed an acceptable safety profile, disease stabilization and preliminary evidence of peripheral pharmacodynamic modulation. GDC-0919 was well