NewLink Genetics Initiates Phase1 Clinical Trial Of NLG919 - Quick Facts

(RTTNews) - NewLink Genetics Corp. (NLNK) announced that it has initiated a first in human Phase 1 clinical trial of NLG919. It is the company's second IDO (indoleamine-(2,3)-dioxygenase) pathway inhibitor that will initially be tested in patients with recurrent advanced solid tumors.

NLG919 is a small-molecule, orally bioavailable, immune checkpoint inhibitor designed to counteract a fundamental mechanism by which tumors evade immune-mediated destruction.

The company said NLG919 represents a novel class of compounds in its IDO pathway platform. The platform includes indoximod, the company's most advanced IDO pathway inhibitor, which is currently in Phase 2 clinical development for the treatment of breast cancer.

The Phase 1 dose-escalation study is designed to evaluate the safety, pharmacokinetics, pharmacodynamics, and initial evidence of activity of NLG919 as determined by overall response rates in up to 36 patients with recurrent advanced solid malignancies.

In preclinical studies, NLG919 has demonstrated encouraging activity in solid tumor models and shown that IDO pathway inhibition is critical to reversal of the local immune suppression which impairs immunological detection and destruction of tumors. NewLink has shown that NLG919 inhibits the IDO pathway by a complementary, yet different mechanism of action than indoximod.

In addition, preclinical data showing that the combined activity of different checkpoint inhibitors, including distinct IDO inhibitors such as NLG919 and indoximod as well as other agents targeting the PD-1 and CTLA-4 pathways, can function synergistically against cancer.