Acrivon Therapeutics is halting work on developing its lead drug for ovarian and bladder cancers, instead focusing the Eli Lilly castoff solely on endometrial cancer.
The Watertown, Massachusetts-based biotech had been evaluating the CHK1/2 inhibitor, called prexasertib or ACR-368, in a phase 2b trial of patients with endometrial cancer. These patients were split between 20 individuals who had tested positive for Acrivon’s OncoSignature biomarker test and 38 who tested negative.
Based on an interim data extract, Acrivon was able to show that the OncoSignature “accurately identified patients whose tumors are sensitive to ACR-368,” with 80% of these individuals seeing their tumor shrink to some extent, according to Acrivon. This cohort saw a confirmed overall response rate of 35%, the biotech said in a Securities and Exchange Commission filing March 25.
“Overall, these results demonstrate significant anti-tumor activity and disease control in BM+ patients with aggressive, refractory tumors that did not respond at all to the last line of prior therapy, and with a confirmed ORR more than double the best ORR observed in the last prior line of therapy for all BM+ patients,” Acrivon said in the filing.
The company had already made endometrial cancer its top priority but used yesterday's filing to announce that it had now “officially deprioritized ovarian and bladder cancers” as targets for ACR-368.
“Due to increased competition and a smaller market opportunity, the company set a high internal clinical bar for ovarian cancer, which preliminary data suggests is unlikely to be met,” Acrivon explained.
In addition, the OncoSignature had been less useful recruiting bladder cancer patients with a suitable biomarker for ACR-368, meaning less than 10 individuals had been enrolled for this indication, the company added.
The clinical resources for these two indications will be redirected to testing ACR-368 in endometrial cancer as well as toward Acrivon’s other clinical-stage candidate, ACR-2316. The WEE1/PKMYT1 inhibitor is currently in a phase 1 trial for patients with advanced solid tumors.
ACR-368’s story dates back to the late 1990s, when it was discovered by Array BioPharma. Lilly had later picked up the CHK1/2 inhibitor before discarding it in 2019 after phase 2 studies didn't show enough promise. In 2021, Acrivon launched with a mission to reignite development of the drug and touted the therapy’s potential when it organized a $99 million IPO the following year.
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