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Acrivon Therapeutics Announces FDA has Granted Breakthrough Device Designation for ACR-368 OncoSignature Assay for Endometrial Cancer
The ACR-368-tailored OncoSignature assay is being used to predict patients most likely to respond to ACR-368 in Acrivon’s ongoing, registrational-intent,
About this update from Acrivon Therapeutics, Inc.
[{"type":"text","content":"The ACR-368-tailored OncoSignature assay is being used to predict patients most likely to respond to ACR-368 in Acrivon’s ongoing, registrational-intent, multicenter Phase 2b trial of ACR-368 in patients with endometrial cancer and other tumor types Clinical data presented at ESMO 2024 demonstrates statistically significant segregation of patient responders in biomarker-positive versus biomarker-negative subgroups based on prospective OncoSignature patient selection (p-value = 0.009) Drug-tailored, proprietary OncoSignature biomarker assays are developed using the generative AI-driven Acrivon Predictive Precision Proteomics (AP3) platform, which is also used for streamlined, biologically rational drug design and indication finding WATERTOWN, Mass., Feb. 05, 2025 (GLOBE NEWSWIRE) -- Acrivon Therapeutics, Inc. (“Acrivon” or “Acrivon Therapeutics”) (Nasdaq: ACRV), a clinical stage precision medicine company utilizing its Acrivon Predictive Precision Proteomics (AP3) platform for the discovery, design, and development of drug candidates through a mechanistic match to patients whose disease is predicted sensitive to the specific treatment, 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 endometrial cancer patients who may benefit from ACR-368 treatment. The designation reflects the 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 the FDA has designated our ACR-368 OncoSignature assay, developed specifically to prospectively predict tumor sensitivity to ACR-368 and used in our advancing registrational-intent clinical study, as a Breakthrough Device for patients with endometrial cancer,” said Peter Blume-Jensen, M.D., Ph.D., chief executive officer, president, and founder of Acrivon Therapeutics. “This is the second such designation for our ACR-368 OncoSignature assay and represents yet another powerful validation of our generative AI-driven AP3 platform. The enrollment and dosing continues for both ACR-368 in our ongoing Phase 2b trials, as well as for ACR-2316, our internally-developed Phase 1 asset, which is a novel, different...