Wednesday, June 29, 2022
Akoya Biosciences, Inc., The Spatial Biology Company®, and Acrivon Therapeutics, Inc., a clinical-stage oncology therapeutics company with proprietary technologies driving a new era of precision-based medicine, today announced an agreement to co-develop, validate, and commercialize Acrivon’s OncoSignature® test, a first-of-its-kind companion diagnostic. The test will be used to identify cancer patients most likely to respond to treatment with ACR-368, a targeted DNA damage response inhibitor therapy being developed by Acrivon. ACR-368 has been cleared by the FDA to be advanced in a Phase 2 master protocol trial to treat patients with ovarian, endometrial, and urothelial cancer based on predicted sensitivity to ACR-368.
ACR-368 has been evaluated in over 1,000 patients and has demonstrated durable monotherapy activity, including complete responses, in a proportion of patients with platinum-resistant ovarian cancer. These patients currently have no effective treatment options, and the median survival time with this disease is less than one year. In addition to ovarian cancer, ACR-368 is being evaluated as a treatment for endometrial and urothelial cancers -- two other high unmet need solid tumor types predicted by OncoSignature® to be highly sensitive to the drug. The OncoSignature® test, developed by Acrivon, will be run on Akoya’s PhenoImager solution during clinical development and, pending ACR-368 approval and commercialization, will enable physicians to identify and treat the patients most likely to respond to the therapy.
Akoya, in partnership with Acrivon, will develop, clinically validate, and seek regulatory co-approval for the OncoSignature® test, and, pending ACR-368 approval, commercialize the test as the exclusive provider of the companion diagnostic required for prescribing ACR-368. The test will leverage the spatial phenotyping capabilities of the PhenoImager solution to localize and quantify the expression of a signature of clinically relevant protein biomarkers within the tumor.
“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,” said Peter Blume-Jensen, M.D., Ph.D., chief executive officer and president of Acrivon. “We believe that Akoya is an ideal partner to develop and commercialize this next-generation companion diagnostic with their technically advanced, quantitative PhenoImager solution. We look forward to working with Akoya towards bringing this companion diagnostic to patients and clinicians around the world.”
In the initial phase of this co-development agreement, studies were conducted in collaboration with Acrivon at Akoya’s CLIA-certified Advanced Biopharma Solutions (ABS) lab to complete the analytical validation of the clinical trial assay version of the OncoSignature® test on the PhenoImager platform. ABS is a premium high-value partner for biopharmaceutical companies enabling the use of Akoya’s platform in clinical trials. In the next phase of the agreement, the companion diagnostic for ACR-368 will be developed and clinically validated.
“We are honored to partner with Acrivon in the advancement of their promising therapy ACR-368, which has the potential to substantially impact the well-being of these patients,” said Brian McKelligon, chief executive officer of Akoya. “We believe that the next generation of personalized medicines will go beyond the genetic markers currently being used today. Our spatial phenotyping technology and complete workflow solution with the PhenoImager platform can enable the sophisticated analyses necessary to achieve diagnostic capabilities required for patient selection, and we are excited to have Acrivon’s leading-edge OncoSignature test run on our solution.”