UroGen is handing an anti-CTLA-4 antibody back to Agenus after concluding phase 1 data for the bladder cancer drug didn’t reach the benchmark for further development.
New Jersey-based UroGen forked over $10 million in upfront cash for the license to the candidate, called zalifrelimab 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 also an opportunity to test out RTGel, UroGen’s sustained-release, hydrogel-based tech designed to improve the therapeutic profiles of existing drugs.
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 viable platform for local delivery 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 the $115 million in clinical development and regulatory milestones and $85 million in commercial milestone paydays that could have come its way if zalifrelimab had achieved success.
Anti-CTLA-4 checkpoint inhibitors have proven their worth in oncology in the form of Bristol Myers Squibb’s blockbuster Yervoy and AstraZeneca’s Imjudo.
The decision by UroGen marks the latest rejection for Agenus after Bristol Myers Squibb axed a TIGIT bispecific antibody pact last year and then 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.