After a fairly disappointing ASCO, Roche is axing work on IDO medication GDC-0919 and handing back the rights to partner NewLink Genetics in a deal that could have been worth $1 billion in biobucks.
This comes after a series of trial hits, with NewLink suffering a setback in its immuno-oncology pipeline just this week after its IDO inhibitor indoximod, touted as the next big thing in cancer research (after CAR-T), failed to show any benefit in a metastatic breast cancer trial.
The Ames, Iowa-based biotech said the phase 2 study didn’t meet its primary objectives of improving overall survival, progression-free survival or the objective response rate when added to standard therapy with taxane drugs in the trial, which enrolled patients with advanced HER2-negative breast cancer.
The result was a fresh blow for NewLink, which has been in the doldrums since it revealed a pancreatic cancer vaccine failed a phase 3 trial last year, with patients receiving placebo actually living longer than those on its algenpantucel-L candidate. The finding cast serious doubts on the future of the company's HyperAcute platform cancer vaccine platform, which was subsequently parked by the company as it focused on its IDO inhibitor candidates.
The indoximod disappointment sparked a steady decline in NewLink’s shares that was not helped by some more clinical news on the firm's IDO portfolio that emerged at ASCO over the weekend.
NewLink presented data on a follow-up IDO inhibitor—navoximod (GDC-0919)—in combination with Roche’s PD-L1 inhibitor Tecentriq (atezolizumab) in 61 patients with advanced solid tumors, with a 10% overall response rate that according to analysts at Jefferies “seemingly does not meaningfully differentiate to PD-(L)1 alone.”
The overall take is that the drug’s performance was “disappointing,” a sentiment seemingly shared by Roche, which said this morning it is handing back all rights to GDC-0919, and coming after the Swiss major had its own problems at ASCO this weekend. Analysts at Jefferies said in a note to clients today that Roche's decision and the ASCO results: "calls into question any value this drug could have as a combination therapy."
Roche isn’t severing all ties, however, and said that the research collaboration with its biologics arm Genentech for work on the next-gen IDO/TDO (tryptophan 2,3-dioxygenase) inhibitors “continues”.
This may be little comfort for the biotech, which got $150 million upfront in the 2014 deal for the med, with a potential $1 billion in biobucks.
“We are obviously disappointed in this decision,” said Charles Link, Jr., M.D., CEO of NewLink Genetics. “We remain committed to advancing our IDO pathway inhibitor indoximod, which continues to generate exciting data in combination with anti-PD-1 agents, cancer vaccines, and chemotherapy in multiple cancer types including melanoma, prostate cancer, acute myeloid leukemia, and pancreatic cancer.”
The biotech was down 28% premarket on the news.