Roche pens death notice for NewLink IDO/TDO cancer collaboration

Just a few weeks out from ASCO, and with more than a touch of inevitability, Roche is axing its IDO/TDO inhibitor work “in its entirety” with partner NewLink Genetics as the fallout from a string of weak IDO trials across biopharma continues.

The pair originally forged the pact back in October 2014, worth potentially around $1 billion (with $150 million upfront), but last summer it started to break up when Roche stopped work on an experimental IDO drug, handing back the rights to its partner.

This came after a series of trial hits for the biotech, with NewLink suffering a setback that same week after its IDO inhibitor indoximod, touted as one of the next big things in cancer research, failed to show any benefit in a metastatic breast cancer trial.

The result was yet another blow for NewLink, which has been in the doldrums since it revealed a pancreatic cancer vaccine failed a phase 3 trial in 2016, 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 cancer vaccine platform, which was subsequently parked by the company as it focused on its IDO inhibitor candidates.

Though backing out of work on that drug, Roche didn’t sever all ties, saying last June that the research collaboration with its biologics arm Genentech for work on the next-gen IDO/TDO (tryptophan 2,3-dioxygenase) inhibitors “continues.”

No longer, however. As per today's SEC filing, “On May 10, 2018, the company [NewLink] received notice from Genentech, a member of the Roche Group, that it is terminating the License and Collaboration Agreement between the parties dated October 14, 2014, or the Genentech Agreement, in its entirety. Such termination will become effective 180 days after our receipt of this notice from Genentech."

“Genentech had previously terminated the Genentech Agreement in part with respect to NLG919, but the agreement remained in force with respect to next generation IDO/TDO inhibitors identified through the research program conducted under the Genentech Agreement.

“Upon termination of the Genentech Agreement in its entirety, the Company’s rights in such next generation compounds will revert to the Company, and Genentech will grant to the Company an exclusive, worldwide, royalty-bearing, sublicensable license, under certain Genentech intellectual property, to research, develop, manufacture and commercialize such next generation compounds, and the Company will be required to pay a low single-digit royalty to Genentech on any sales of next generation compounds, should the Company proceed to develop and commercialize them.”

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This comes after a torrid few months for IDO research: Just over a month ago, the combination of Incyte’s IDO1 inhibitor epacadostat and Merck & Co.’s blockbuster PD-1 star Keytruda was supposed to pose a major threat to rival Bristol-Myers Squibb’s melanoma franchise—but the data didn’t come through.

That phase 3 data found no benefit on progression-free survival for the duo compared to Keytruda alone—and little chance that the overall survival figures would rescue the study—and Incyte said the trial has been abandoned.

Then, a month later on May 1, Bristol-Myers Squibb pulled two phase 3 clinical trials of the IDO1 inhibitor it acquired through an $800 million takeover of Flexus, coming off the back of that Incyte trial.

On the same day, Incyte also took the ax to its suite of late-phase epacadostat trials after digesting the implications of that pivotal study blowup. The cull saw Incyte downgrade two pivotal epacadostat-Keytruda trials to phase 2 studies and back away from six other late-stage tests of its IDO inhibitor.

Roche is now joining the retreat.