Acrivon Therapeutics, Inc. announced that the company has been granted two Fast Track designation by the U.S. Food and Drug Administration (FDA) for the development of ACR-368 in platinum-resistant ovarian cancer and endometrial cancer. Fast Track designation is intended to facilitate the development and expedite the review of promising investigational drugs to treat serious conditions with significant unmet medical needs. A drug candidate that receives Fast Track designation can be eligible for Accelerated Approval and Priority Review, and often have the opportunity to communicate more frequently with the FDA on trial design and data, among other benefits if relevant criteria are met.

One Fast Track development program designation was granted for the investigation of ACR-368 as a monotherapy treatment for patients with OncoSignature(R) positive, locally advanced, or metastatic, recurrent platinum-resistant high-grade ovarian carcinoma who have received at least one prior systemic treatment regimen. ACR-368, also known as prexasertib, is a targeted DNA damage response inhibitor therapy. ACR-368 is being studied in a multicenter, open-label Phase 2 clinical trial with single-arm, potentially registrational cohorts of patients with platinum-resistant ovarian cancer, endometrial adenocarcinoma, and urothelial cancers based on OncoSignature-pred predicted sensitivity to ACR-368.

The OncoSignature test is a first-of-its-kind drug-specific companion diagnostic that uses proteomics biomarkers to identify the patients most likely to benefit from a drug candidate. OncoSignature tests are developed using Acrivon's Predictive Precision Proteomics (AP3) platform, which matches the drug mechanism of action with the critical tumor-driving pathways.