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
“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
The Breakthrough Devices Program is intended to provide patients and health care providers with timely access to medical devices by speeding up development, assessment, and review for premarket approval, 510(k) clearance, and marketing authorization.
Acrivon has partnered with Akoya Biosciences to co-develop, validate, and commercialize Acrivon’s ACR-368 OncoSignature assay.
About Acrivon Therapeutics
Acrivon is 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 Acrivon’s proprietary proteomics-based patient responder identification platform, Acrivon Predictive Precision Proteomics, or AP3. The AP3 platform is engineered to measure compound-specific effects on the entire tumor cell protein signaling network and drug-induced resistance mechanisms in an unbiased manner. These distinctive capabilities enable AP3’s direct application for drug design optimization for monotherapy activity, the identification of rational drug combinations, and the creation of drug-specific proprietary OncoSignature companion diagnostics that are used to identify the patients most likely to benefit from Acrivon’s drug candidates. Acrivon is currently advancing its lead candidate, ACR-368, a selective small molecule inhibitor targeting CHK1 and CHK2 in a potentially registrational Phase 2 trial across multiple tumor types. The company has received Fast Track designation from the
Forward-Looking Statements
This press release includes certain disclosures that contain “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995 about us and our industry that involve substantial risks and uncertainties. All statements other than statements of historical facts contained in this press release, including statements regarding our future results of operations or financial condition, business strategy and plans and objectives of management for future operations, are forward-looking statements. In some cases, you can identify forward-looking statements because they contain words such as “anticipate,” “believe,” “contemplate,” “continue,” “could,” “estimate,” “expect,” “intend,” “may,” “plan,” “potential,” “predict,” “project,” “should,” “target,” “will,” or “would” or the negative of these words or other similar terms or expressions. Forward-looking statements are based on Acrivon’s current expectations and are subject to inherent uncertainties, risks and assumptions that are difficult to predict. Factors that could cause actual results to differ include, but are not limited to, risks and uncertainties that are described more fully in the section titled “Risk Factors” in our reports filed with the
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