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Akoya Biosciences, Acrivon Therapeutics Partner to Develop CDx

NEW YORK – Akoya Biosciences and Acrivon Therapeutics on Tuesday announced a partnership to codevelop, validate, and commercialize a companion diagnostic test for Acrivon's targeted DNA damage response inhibitor, ACR-368.

Financial terms of the partnership were not disclosed.

The OncoSignature test, developed by Acrivon, will be used to identify cancer patients most likely to respond to treatment with ACR-368, a targeted DNA damage response inhibitor therapy. The drug has been cleared by the US Food and Drug Administration to be advanced in a Phase II master protocol trial to treat patients with ovarian, endometrial, and urothelial cancer based on predicted sensitivity to the therapy.

The test will run on Akoya's PhenoImager platform during clinical development, leveraging the instrument's spatial phenotyping capabilities to localize and quantify the expression of a signature of clinically relevant protein biomarkers within the tumor, the companies said. Analytical validation studies of the clinical trial version of OncoSignature during the initial phase of the collaboration were conducted at Akoya's CLIA-certified Advanced Biopharma Solutions lab.

Akoya, in partnership with Acrivon, will develop, clinically validate, and seek regulatory co-approval for the OncoSignature test. Pending approval of ACR-368, Akoya will commercialize the test and be the exclusive provider of the CDx.

"The ability to select patients for ACR-368 is a foundational part of our efficient clinical development strategy and is a critical part of our mission to bring our targeted therapies to the patients most likely to benefit from treatment," Acrivon CEO and President Peter Blume-Jensen said in a statement. "We believe that Akoya is an ideal partner to develop and commercialize this next-generation companion diagnostic with their technically advanced, quantitative PhenoImager solution."