FDA Recognizes Acrivon Therapeutics' Breakthrough Approach to Ovarian Cancer Treatment with ACR-368 OncoSignature Assay Approval

The U.S. Food and Drug Administration has granted Breakthrough Device designation to Acrivon Therapeutics for its ACR-368 OncoSignature assay, marking a significant milestone for precision medicine in oncology. This multiplex immunofluorescence test is specifically designed to identify ovarian cancer patients most likely to respond to the company’s ACR-368 treatment—a selective inhibitor targeting CHK1 and CHK2 proteins involved in DNA damage response.

What This Designation Means

The Breakthrough Device Program accelerates the development and review pathway for medical devices addressing life-threatening or irreversibly debilitating conditions. By securing this recognition, Acrivon Therapeutics has demonstrated that its OncoSignature assay represents a meaningful advance in how doctors can match cancer patients to therapies most likely to work for their tumors.

Peter Blume-Jensen, M.D., Ph.D., Acrivon’s CEO and founder, highlighted the significance: the company’s proprietary AP3 platform—Acrivon Predictive Precision Proteomics—enables the development of proteomic-based diagnostic tools that predict individual patient sensitivity to specific drug candidates. This represents what leadership describes as a first-of-its-kind designation for such an assay type.

The Clinical Trial Connection

The ACR-368 OncoSignature assay is currently being used in Acrivon’s ongoing Phase 2 registrational-intent trial, where patients are selected for treatment based on their predicted tumor sensitivity as determined by the assay. Beyond ovarian cancer, the trial is evaluating the drug across multiple tumor types. The company previously received Fast Track designation from the FDA for investigating ACR-368 in platinum-resistant ovarian and endometrial cancer patients.

Technology Behind the Innovation

Acrivon Therapeutics developed the OncoSignature assay through its proprietary AP3 platform, which measures how compounds affect the entire protein signaling network within tumor cells and identifies drug-induced resistance mechanisms. This comprehensive proteomic approach enables both drug design optimization and the discovery of rational drug combinations.

The company has partnered with Akoya Biosciences for co-development, validation, and eventual commercialization of the ACR-368 OncoSignature assay. Preclinical validation included two separate, blinded, prospectively-designed studies using pretreatment tumor biopsies from previous Phase 2 trials in ovarian cancer patients.

Broader Pipeline Development

Beyond ACR-368, Acrivon Therapeutics is leveraging its AP3 platform across additional programs. The company’s development candidate ACR-2316 is a selective dual WEE1/PKMYT1 inhibitor, with several other preclinical programs targeting critical nodes in DNA damage response pathways. This multi-program approach underscores how the AP3 platform enables systematic precision oncology drug discovery and development.