NewLink Genetics sees enrolling majority of Indigo301 trial by end 2018
NewLink Genetics earlier announced Indigo301, the name of its upcoming Phase 3 trial of indoximod plus PD-1 inhibitors for patients with advanced melanoma, and outlined 2018 business priorities to support this trial. In addition, the company updated clinical and financial guidance and provided preliminary unaudited financial information for year-end 2017. To expedite the enrollment of Indigo301, NewLink Genetics has expanded the planned number of trial sites both within and outside of the US and plans several clinical recruitment initiatives to engage with the oncology community with the goal to enroll the majority of patients in 2018. As a result of these clinical planning efforts, NewLink Genetics is accordingly updating its guidance for clinical trials as follows: Enroll the majority of Indigo301 trial by the end of 2018; Phase 2 results for indoximod + PD-1 blockade in advanced melanoma expected in 2018; Phase 2 results for indoximod + gem/nab-paclitaxel in pancreatic cancer expected 1H 2018; Phase 2 randomized AstraZeneca collaboration in pancreatic cancer to initiate 1H 2018. "Entering 2018, we have aligned our business and investments to drive Indigo301 and other high-potential development programs. As we continue to progress, we remain committed to maintaining the strength of our balance sheet in support of our most promising clinical programs," said CFO Jack Henneman. NewLink Genetics ended 2017 with approximately $158M in cash and cash equivalents, the company noted.