Genentech, a member of the Roche Group, will return to NewLink Genetics rights to cancer candidate GDC-0919 (navoximod), NewLink acknowledged today.
GDC-0919 is an indoleamine-pyrrole 2,3-dioxygenase (IDO) inhibitor that was part of a nearly three-year-old solid tumor therapy collaboration between the companies—a partnership that was once expected to generate up to $1.15 billion-plus for NewLink.
The companies will continue their research collaboration, aimed at discovering next-generation IDO/TDO (tryptophan 2,3-dioxygenase) inhibitors, NewLink said.
The end of the collaboration comes almost a week after NewLink acknowledged that a Phase II study of indoximod plus taxane chemotherapy—either docetaxel or paclitaxel—failed to meet its primary endpoints of a statistically significant difference in progression-free survival (PFS) compared with placebo plus taxane chemotherapy in patients with metastatic breast cancer. NewLink cited topline data and said June 2 that full results will be presented at an unspecified “upcoming academic meeting.”
According to a NewLink regulatory filing today, Genentech could still generate money from GDC-0919. In exchange for regaining rights to the candidate, NewLink agreed to pay Genentech a “low single-digit” royalty on any sales of GDC-0919 should NewLink proceed to develop and commercialize the compound. Genentech agreed to supply NewLink with GDC-0919 for one year after termination and facilitate NewLink’s efforts to obtain an alternative source of supply for GDC-0919.
NewLink licensed GDC-0919, then called NLG919, to Roche when the companies launched their IDO/TDO therapy collaboration in October 2014, with Genentech paying NewLink $150 million upfront. The companies reasoned that targeting the IDO and TDO pathways represented a breakthrough approach to fighting cancer, citing earlier studies showing that the IDO pathway was active both within tumor cells as a direct defense against T-cell attack and within antigen-presenting cells in tumor-draining lymph nodes.
The termination of Genentech’s rights to GDC-0919 takes effect within 180 days of NewLink receiving formal notice from Genentech.
“We are obviously disappointed in this decision,” NewLink CEO Charles J. Link, Jr., M.D., said in a statement.
He said the company remained committed to advancing its other IDO pathway inhibitor, indoximod, saying it “continues to generate exciting data in combination with anti-programmed cell death protein 1 (anti-PD-1) agents, cancer vaccines, and chemotherapy in multiple cancer types including melanoma, prostate cancer, acute myeloid leukemia, and pancreatic cancer.”
On Monday, NewLink trumpeted Phase II data showing that the combination of indoximod with the Dendreon/Valeant Pharmaceuticals International cancer vaccine Provenge® (sipuleucel-T) generated statistically significant improvement in median radiographic (r) PFS compared to placebo.
Dendreon showed rPFS of 10.3 months compared with 4.1 months for placebo, NewLink reported in a poster presentation at the 2017 American Society of Clinical Oncology (ASCO) Annual Meeting in Chicago.
In presenting first-quarter results on May 4, NewLink added that it also had in development a novel prodrug of indoximod, NLG802, which the company expected will advance to clinical studies by the end of the third quarter.
Investors responded to the end of GDC-0919 development with Roche with a selloff that sent NewLink shares down 30.5% from yesterday’s close of $10.62, to $7.38 in premarket trading as of 8:54 a.m.