Acrivon Therapeutics (NASDAQ: ACRV) has achieved a significant milestone as the U.S. Food and Drug Administration (FDA) granted Breakthrough Device designation to its ACR-368 OncoSignature assay, a diagnostic tool designed for endometrial cancer patient selection.
The multiplex immunofluorescence assay serves as a companion diagnostic tool for ACR-368, Acrivon's lead drug candidate. This innovative diagnostic approach aims to identify patients who are most likely to benefit from ACR-368 therapy, representing a step forward in precision medicine for gynecologic cancers.
Clinical Evidence Supporting Breakthrough Status
The FDA's decision was supported by compelling clinical data from an ongoing registrational-intent Phase IIb trial. The study demonstrated particularly promising results in endometrial cancer patients, with ACR-368 OncoSignature-positive (BM+) patients achieving a confirmed overall response rate of 62.5%. This remarkable response rate underscores the potential of the biomarker-driven patient selection strategy.
Significance of Breakthrough Device Designation
The Breakthrough Device designation is reserved for medical devices that demonstrate potential to provide more effective treatment or diagnosis for life-threatening or irreversibly debilitating conditions. This designation may expedite the development and regulatory review process, potentially accelerating patient access to this precision medicine approach.
Clinical Trial Progress
The ACR-368 OncoSignature assay is currently being evaluated in a registrational-intent Phase IIb trial, which includes patients with locally advanced or metastatic, recurrent endometrial cancer, along with other tumor types. The trial's design reflects the growing trend toward biomarker-guided patient selection in oncology clinical development.
This development represents a significant advance in the field of precision oncology, potentially offering a more targeted approach to treating endometrial cancer, a condition that often presents significant therapeutic challenges in its advanced stages.
