Acrivon Therapeutics Announces FDA has Granted Breakthrough Device Designation for ACR-368 OncoSignature Assay for Endometrial Cancer

Core Insights - Acrivon Therapeutics has received FDA Breakthrough Device designation for its ACR-368 OncoSignature assay, aimed at identifying endometrial cancer patients likely to benefit from ACR-368 treatment [1][2][5] - Clinical data presented at ESMO 2024 shows a confirmed overall response rate (ORR) of 62.5% for ACR-368 in endometrial cancer, with significant segregation of patient responders based on biomarker status (p-value = 0.009) [1][2][5] - The Acrivon Predictive Precision Proteomics (AP3) platform is utilized for drug design and patient selection, enhancing the precision of oncology treatments [1][4][6] Company Overview - Acrivon Therapeutics is a clinical stage biopharmaceutical company focused on precision oncology, utilizing its proprietary AP3 platform for drug candidate development [4] - The company is advancing its lead candidate ACR-368, a selective small molecule inhibitor targeting CHK1 and CHK2, in a Phase 2 trial across multiple tumor types [4][6] - Acrivon is also developing ACR-2316, a novel WEE1/PKMYT1 inhibitor, which has completed enrollment in the first two dose-escalation cohorts of its Phase 1 trial [2][6] Market Context - There are approximately 30,000 new cases of high-grade, locally advanced or metastatic endometrial cancer annually in the U.S., indicating a growing market for targeted therapies like ACR-368 [2] - The FDA's Breakthrough Devices Program aims to expedite access to medical devices that can significantly improve treatment or diagnosis for serious conditions [3]