On July 27, 2017 NewLink Genetics Corporation (NASDAQ: NLNK) reported first patient dosed in the Phase 1 study of NLG802, a novel prodrug of indoximod. NLG802 is an investigational agent targeting the IDO pathway and represents an important step in the company’s strategic planning and intellectual property (IP) management (Press release, NewLink Genetics, JUL 27, 2017, View Source [SID1234519909]).
The NLG802 trial is a Phase 1 open-label clinical trial for patients with advanced solid tumors designed to evaluate the safety, tolerability, and pharmacokinetics of escalating oral doses. The trial will utilize a standard 3+3 dose-escalation design.
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"Preclinical data for NLG802 have shown an advantageous pharmacokinetic profile in preclinical models and were presented in April at the AACR (Free AACR Whitepaper) annual meeting," said Charles J. Link, Jr., MD, Chairman, Chief Executive Officer and Chief Scientific Officer. "NLG802 further expands the lifecycle and IP surrounding our evolving immuno-oncological platform."
Trial specific information is available on clinicaltrials.gov
About NLG802
NLG802 is an investigational, orally available prodrug of indoximod, a small molecule targeting the IDO Pathway. The IDO Pathway is one of the key immuno-oncology targets involved in regulating the tumor microenvironment and immune escape. NewLink Genetics is currently evaluating NLG802 in a Phase 1 dose-escalation clinical trial in cancer patients to assess the safety and pharmacokinetics of NLG802.