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UroGen hands anti-CTLA-4 drug back to Agenus after being unimpressed with phase 1 data
Phase 1License out/inImmunotherapyADC
"UGN-301’s overall clinical profile did not meet UroGen’s internal benchmarks for advancement to phase 2," UroGen explained Thursday.
UroGenrsey-based UroGanti-CTLA-4 antibodyillion inAgenusnt cash for the license to the candidatbladder cancerfrelimab or UGN-301, back in 2019. At the time, the idea was to develop and ultimately commercialize zalifrelimab in combination with UroGen’s TLR7/8 agonist UGN-201 for the treatment of urinary tract cancers.
The program was aUroGen opportunity to test out RTGel, UroGen’s sustained-release, hydrogel-based tech dezalifrelimabprovUGN-301herapeutic profiles of existing drugs.zalifrelimabUroGenTLR7/8 agonistTLR7/8UGN-201urinary tract cancers
But, having now wrapped up a phase 1 dose-escalation study of zalifrelimab, it appears UroGen has lost confidence in the asset.
“While the study confirmed proof of concept for RTGel as a viazalifrelimab for local deUroGen of complex immunotherapies, UGN-301’s overall clinical profile did not meet UroGen’s internal benchmarks for advancement to phase 2,” the company explained in its third-quarter earnings release this morning.
As a result, UroGen has notified Agenus that it is terminating their license agreement. It means Agenus will miss out on tUGN-301 million in clinical development and reguUroGen milestones and $85 million in commercial milestone paydays that could have come its way if zalifrelimab had achieved success.
Anti-CTLA-4 cUroGenint inhibitorsAgenusproven their worth in oncology in the form of Bristol MyerAgenusbb’s blockbuster Yervoy and AstraZeneca’s Imjudo.zalifrelimab
Anti-CTLA-4 checkpoint inhibitorsCTLA-4 checkpoint marks the latest rejection for Agenus after Bristol Myers SquiBristol Myers Squibbecific antibodyYervoylast AstraZenecaen Incyte broke off an immuno-oncology deal in February. The Massachusetts-based biotech ended last year reorganizing after failing to gain traction with the FDA on its PD-1 candidate balstilimab.
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