NewLink Genetics Corp. (NASDAQ: NLNK) shares hit an all-time low in Monday’s session after the company provided an update on its brain tumor trial. Although these results were relatively positive, the firm’s separate smaller melanoma trial update is what really tanked the stock.
Specifically, the firm reported initial data from NLG2105, a Phase 1 study evaluating indoximod, its indoleamine 2,3-dioxygenase (IDO) pathway inhibitor, in combination with radiation and chemotherapy for the treatment of pediatric patients with progressive brain tumors during the “Multimodality Immuno-oncology Approaches” session at the American Association for Cancer Research 2018 Annual Meeting in Chicago.
In aggregate, the 29 subjects in the dose-escalation phase of the study had a median progression-free survival of 6.2 months and median time on study (time to regimen failure) of 11.7 months. The treatment continued to be well tolerated with minimal toxicity attributed to indoximod.
Theodore S. Johnson, M.D., Ph.D., Associate Professor of Pediatrics at Augusta University, lead investigator for the trial, commented:
These early data, though from a small cohort of pediatric patients, demonstrate the potential of the indoximod plus radiochemotherapy combination without an increase in toxicity for these children.
Separately, the company determined that it will not initiate the randomization portion of Indigo301, its study of indoximod in combination with pembrolizumab or nivolumab for patients with advanced melanoma. NewLink’s clinical team will evaluate the design, trial size and feasibility of an alternative randomized evaluation of indoximod in melanoma in the context of the failure of a competitor’s (Merck and Incyte) trial of its enzymatic IDO inhibitor in a similar clinical setting.
NewLink will present final results from its Phase 2 trial in melanoma and its single-arm Phase 2 trial in pancreatic cancer at an upcoming medical conference in the first half of 2018.
Shares of NewLink were last seen down 14% at $3.84, with a consensus analyst price target of $8.00 and a 52-week range of $3.75 to $20.47.