The long wait for phase 2 data on Ultimovacs’ cancer vaccine has ended in disappointment. After a series of delays, the biotech reported the failure of the melanoma study Thursday—and outlined plans to cut costs to keep going into 2025.
Ultimovacs’ study assessed the effect of adding UV1, a candidate designed to induce a T-cell response against an enzyme that is active in most cancer cells, to Bristol Myers Squibb’s checkpoint inhibitors Opdivo and Yervoy. The biotech originally predicted the trial would reach its primary endpoint in the first half of 2023, but the study dragged on, prompting a change to the protocol to bring it to an end.
Now, Ultimovacs has revealed the study failed to hit its primary and secondary endpoints. The primary endpoint looked at progression-free survival, while Ultimovacs assessed metrics including overall survival and objective response rate as secondary measures. Ultimovacs is keeping the faith, though.
“Despite these negative results, we remain committed to UV1. This was a failed study, not a failed UV1. I think it is important to reinforce that notion. UV1 has shown benefits, and we hope that it will continue to show these benefits. We remain committed to continuing supporting the ongoing studies,” Ultimovacs CEO Carlos de Sousa said on a conference call with investors to discuss the results.
The failure will have consequences, though. In February, Ultimovacs told investors its current cash would see it through 2024, a slight increase over its previous forecast that happened without taking actions to cut costs.
With Ultimovacs remaining committed to UV1 but still waiting for a midphase hit, de Sousa set out plans to work with the board to extend the cash runway beyond readouts from other studies. The biotech is yet to finalize the “cash preservation” actions, but de Sousa said the goal is to “finance the operations into 2025” and reach “further data points like, for instance, DOVACC.”
DOVACC is one of five phase 2 trials of UV1. The first two trials, INITIUM and NIPU, failed their primary endpoints, although the latter study was partly redeemed by a hit on overall survival. The FOCUS head and neck cancer trial is scheduled to read out in the third quarter, with the DOVACC ovarian cancer study set to follow in the first half of next year. Data from the fifth trial, LUNGVAC, are due later in 2025.