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Acrivon Therapeutics Announces FDA Grants Fast Track Designation for Development of ACR-368 in Platinum-Resistant Ovarian Cancer and Endometrial Cancer
- In previous Phase 2 clinical trials involving more than 400 patients, ACR-368 produced deep, durable monotherapy responses, including complete responses, in
About this update from Acrivon Therapeutics, Inc.
[{"type":"text","content":"- In previous Phase 2 clinical trials involving more than 400 patients, ACR-368 produced deep, durable monotherapy responses, including complete responses, in a proportion of patients with solid tumors, including platinum-resistant ovarian cancer -Previous blinded, prospectively-designed studies have demonstrated that the ACR-368 OncoSignature test is able to enrich for responders in two separate pretreatment tumor biopsy studies in patients with ovarian cancer previously treated with ACR-368 and in endometrial cancer patient-derived xenograft models WATERTOWN, Mass., May 09, 2023 (GLOBE NEWSWIRE) -- Acrivon Therapeutics, Inc. (“Acrivon” or “Acrivon Therapeutics”) (Nasdaq: ACRV), a clinical stage biopharmaceutical company developing precision oncology medicines that it matches to patients whose tumors are predicted to be sensitive to each specific medicine by utilizing its proprietary proteomics-based patient responder identification platform, today announced that the company has been granted two Fast Track designations 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® positive, locally advanced, or metastatic, recurrent platinum-resistant high-grade ovarian carcinoma who have received at least one prior systemic treatment regimen. The second Fast Track development program designation was granted for the investigation of ACR-368 as a monotherapy treatment for patients with OncoSignature positive, recurrent high-grade endometrial cancer who have received at least two prior systemic treatment regimens. ACR-368, also known as prexasertib, is a targeted DNA damage response inhibitor therapy. ACR-368 is being studied in a multicenter, open-label Ph...