Acrivon Shifts Focus to Endometrial Cancer, Halts Development for Ovarian and Bladder Cancers

Acrivon Therapeutics, a Watertown, Massachusetts-based biotech company, has announced a significant shift in its clinical development strategy for its lead drug candidate, ACR-368 (prexasertib). The company has decided to halt development for ovarian and bladder cancers, instead focusing solely on endometrial cancer.

Promising Results in Endometrial Cancer

In a recent Securities and Exchange Commission filing, Acrivon reported encouraging interim data from its phase 2b trial of ACR-368 in endometrial cancer patients. The study, which included both OncoSignature biomarker-positive and negative patients, demonstrated the effectiveness of Acrivon's proprietary biomarker test in identifying patients likely to respond to the treatment.

According to the company, 80% of OncoSignature-positive patients experienced tumor shrinkage to some extent. More notably, this cohort achieved a confirmed overall response rate (ORR) of 35%, which Acrivon stated was "more than double the best ORR observed in the last prior line of therapy for all BM+ patients."

Strategic Realignment and Resource Allocation

Acrivon's decision to deprioritize ovarian and bladder cancers stems from several factors. For ovarian cancer, the company cited increased competition and a smaller market opportunity, setting a high internal clinical bar that preliminary data suggested was unlikely to be met.

In the case of bladder cancer, Acrivon faced challenges in recruiting patients with a suitable biomarker for ACR-368 using its OncoSignature test. As a result, enrollment for this indication remained below 10 individuals.

The clinical resources previously allocated to these indications will now be redirected to further testing of ACR-368 in endometrial cancer. Additionally, Acrivon plans to bolster support for its other clinical-stage candidate, ACR-2316, a WEE1/PKMYT1 inhibitor currently in a phase 1 trial for patients with advanced solid tumors.

ACR-368: A Drug's Journey

ACR-368, also known as prexasertib, has had an interesting development history. Originally discovered by Array BioPharma in the late 1990s, the CHK1/2 inhibitor was later acquired by Eli Lilly. However, Lilly discontinued development in 2019 after phase 2 studies failed to show sufficient promise.

In 2021, Acrivon Therapeutics launched with the mission to revive the drug's development. The company's belief in ACR-368's potential was further emphasized when it raised $99 million through an initial public offering (IPO) the following year.

With this latest strategic shift, Acrivon aims to capitalize on the promising results seen in endometrial cancer, potentially breathing new life into a once-discarded compound and addressing an important unmet medical need.