FDA grants breakthrough device designation to Acrivon’s OncoSignature assay for endometrial cancer

Acrivon Therapeutics has secured a Breakthrough Device designation from the U.S. Food and Drug Administration (FDA) for its OncoSignature assay approval, a biomarker-driven diagnostic test designed to predict which endometrial cancer patients may respond to ACR-368 treatment. This regulatory milestone underscores the potential of precision oncology treatment in improving patient outcomes by personalizing cancer therapies.

The FDA’s Breakthrough Device designation is awarded to medical technologies that have the potential to provide more effective treatment or diagnosis for life-threatening or debilitating diseases. Acrivon’s OncoSignature assay, a multiplex immunofluorescence test, aligns with the agency’s goal of accelerating the development and review of promising innovations in oncology.

Acrivon is currently evaluating ACR-368 in a registrational-intent Phase 2b trial, focusing on endometrial cancer and other solid tumors. The OncoSignature assay approval allows clinicians to identify patients most likely to respond to ACR-368 based on tumor-specific biomarker expression. This patient selection approach enhances the efficacy of targeted therapies while reducing unnecessary exposure to ineffective treatments.

What Makes Acrivon’s OncoSignature Assay a Game-Changer?

The Breakthrough Device designation for OncoSignature is the second such recognition from the FDA, reinforcing its potential in precision medicine. Acrivon’s proprietary Acrivon Predictive Precision Proteomics (AP3) platform, powered by generative AI, plays a crucial role in developing biomarker-driven diagnostic tools and optimizing precision oncology treatment strategies.

At the 2024 European Society for Medical Oncology (ESMO) Congress, Acrivon presented clinical data demonstrating a statistically significant correlation between OncoSignature biomarker status and patient response to ACR-368. The study showed a confirmed overall response rate (ORR) of 62.5% (95% CI, 30.4-86.5) in biomarker-positive patients, highlighting the assay’s accuracy in identifying responders. The p-value of 0.009 further validated the reliability of OncoSignature in selecting patients most likely to benefit from treatment.

This approach to precision oncology treatment is particularly crucial for endometrial cancer, a disease with limited targeted therapy options. Each year, approximately 30,000 new cases of high-grade, locally advanced, or metastatic endometrial cancer are diagnosed in the U.S., with many patients progressing despite standard treatments. Acrivon’s assay offers a more personalized treatment pathway by enabling oncologists to tailor ACR-368 administration based on tumor-specific biomarkers.

What Are the Implications of FDA’s Breakthrough Device Designation?

The Breakthrough Device designation allows Acrivon to engage in an accelerated regulatory process, benefiting from priority FDA review, enhanced communication, and a streamlined approval pathway for potential commercialization. This designation is designed to fast-track novel medical devices that demonstrate clear advantages over existing technologies, ensuring that innovative solutions reach patients more efficiently.

For Acrivon, this regulatory advancement strengthens its ability to integrate precision oncology treatment into mainstream clinical practice. It also supports ongoing research into biomarker-driven therapies, paving the way for further breakthroughs in personalized medicine. The company’s AP3 platform continues to guide OncoSignature assay approval, contributing to the broader field of targeted cancer treatment.

How Is Acrivon Expanding Its Oncology Pipeline?

Beyond ACR-368 and its companion OncoSignature assay, Acrivon is developing additional oncology assets through its AP3-driven drug discovery platform. The company’s second clinical-stage asset, ACR-2316, is a novel WEE1/PKMYT1 inhibitor designed to induce cancer cell apoptosis by targeting multiple cell cycle regulators. The first two dose-escalation cohorts of the ACR-2316 Phase 1 trial have been completed, and the third cohort has commenced dosing.

The AP3 platform, which powers the development of these therapies, employs AI-driven proteomic analysis to map drug-induced changes in tumor protein signaling networks. This data-intensive approach enables Acrivon to rationally design and optimize precision oncology treatments by predicting patient responses based on comprehensive biomarker profiling.

Acrivon is also leveraging machine learning through its proprietary AP3 Interactome computational analytics platform. This tool integrates high-resolution phosphoproteomic data to refine drug targeting strategies, optimize combination therapies, and expand the application of biomarker-driven treatment selection.

What Does This Mean for the Future of Precision Oncology?

The FDA’s Breakthrough Device designation for Acrivon’s OncoSignature assay approval marks a significant step forward in personalized cancer treatment. The ability to accurately identify responsive patient populations has the potential to improve treatment efficacy, reduce adverse effects, and enhance overall survival rates for endometrial cancer patients.

Acrivon’s precision oncology treatment strategy, driven by AI-powered biomarker analysis, represents a shift toward a more individualized approach to cancer therapy. With regulatory support, promising clinical data, and ongoing drug development efforts, the company is well-positioned to advance the future of biomarker-driven oncology treatment.

As Acrivon progresses with its clinical programs, the continued validation of its OncoSignature assay approval could influence the adoption of precision medicine across multiple cancer indications. The combination of cutting-edge diagnostics and AI-driven drug discovery underscores the growing impact of targeted therapies in reshaping the oncology landscape.