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Acrivon Therapeutics Announces FDA has Granted Breakthrough Device Designation for ACR-368 OncoSignature Assay for Ovarian Cancer
The ACR-368-tailored OncoSignature assay is being used in Acrivon’s ongoing registrational-intent Phase 2 trial to predict patients most likely to respond to
About this update from Acrivon Therapeutics, Inc.
[{"type":"text","content":"The ACR-368-tailored OncoSignature assay is being used in Acrivon’s ongoing registrational-intent Phase 2 trial to predict patients most likely to respond to the CHK1/2 inhibitor ACR-368 in three tumor types Drug-tailored, proprietary OncoSignature assays are developed using the Acrivon Predictive Precision Proteomics (AP3) platform which is also used more broadly to uncover resistance mechanisms and rational drug combinations, and for biological rational drug design for Acrivon’s drug candidates WATERTOWN, Mass., Nov. 28, 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, Acrivon Predictive Precision Proteomics or AP3, announced the U.S. Food and Drug Administration (FDA) has granted Breakthrough Device designation for the ACR-368 OncoSignature assay, a multiplex immunofluorescence assay for the identification of ovarian cancer patients who may benefit from ACR-368 treatment. The designation reflects FDA’s determination that the device is reasonably expected to provide for more effective treatment or diagnosis of life-threatening or irreversibly debilitating human disease or conditions. “We are pleased that our ACR-368 OncoSignature assay, developed specifically to predict tumor sensitivity to ACR-368 and used in our ongoing registrational-intent clinical study to treat patients based on OncoSignature-predicted sensitivity, has been designated by the FDA as a Breakthrough Device,” said Peter Blume-Jensen, M.D., Ph.D., chief executive officer, president, and founder of Acrivon Therapeutics. “It is exclusively through our proprietary AP3 platform that we are able to develop these proteomic-based assays that are designed to predict the patients most likely to benefit from treatment with our drug candidates. We believe this designation is the first of its kind for such an assay, and represents yet another powerful validation of our AP3 platform. The designation importantly also highlights meaningful potential value to patients as we continue to progress ACR-368 in the clinic.” The Breakthrough Devices Program is i...