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Acrivon Therapeutics to Study CHK1/2 Inhibitor ACR-368, Predictive Diagnostic in Phase II Trial

NEW YORK – Acrivon Therapeutics said on Wednesday the US Food and Drug Administration has cleared an investigational new drug application for its CHK1/2 inhibitor ACR-368 to begin a Phase II master protocol trial for patients with ovarian, endometrial, and urothelial cancer.

Patients will be selected for the two treatment groups using Acrivon's OncoSignature proteomic companion diagnostic that can predict sensitivity to CHK1/2 inhibition by ACR-368. Patients with positive results from the OncoSignature diagnostic will receive ACR-368 monotherapy and patients with negative results will receive ACR-368 in combination with low-dose gemcitabine.

The OncoSignature test analyzes pretreatment tumor biopsies for sensitivity or resistance to ACR-368. Acrivon's preclinical research found that low-dose gemcitabine re-sensitizes resistant tumors to ACR-368.

The trial will enroll patients with locally advanced or metastatic, recurrent platinum-resistant high-grade ovarian cancer, platinum-resistant urothelial cancer, and endometrial cancer.

"Acrivon's next-generation proteomics-based precision medicine platform is engineered to uncover the disease-driving mechanisms that are uniquely sensitive to our drugs or rational drug combinations in individual patient tumors, independent of genetic alterations," Acrivon CEO Peter Blume-Jensen said in a statement. "Our strategy is to apply the ACR-368-tailored OncoSignature test to a tumor biopsy from the patient before the start of treatment and use that result to direct ACR-368 to only those patients predicted to be most likely to benefit from either monotherapy treatment or the combination therapy."

Patients who test positive on the OncoSignature test will be enrolled in the Phase II trial, while those who test negative will be enrolled in a separate Phase Ib/II study that will determine the recommended dose of the ACR-368-gemcitabine combination.

Acrivon, based in Watertown, Massachusetts, is also studying its lead candidate ACR-368 in anal cancer, head and neck cancer, and other solid tumors. The firm has two additional undisclosed discovery programs in preclinical development. The company licensed ACR-368 worldwide from Eli Lilly last year.