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Leica to Develop Companion Dx for Arno's Cancer Drug

NEW YORK (GenomeWeb News) – Cancer drug developer Arno Therapeutics and Leica Biosystems have partnered to develop a companion diagnostic for a cancer therapy being developed by Arno, the firms said today.

Under the co-development agreement, Newcastle Upon Tyne, UK-based Leica will develop an immunohistochemical in vitro diagnostic test to detect activation of the progesterone receptor that Arno's drug, onapristone, was designed to block.

The company said that blocking APR inhibits the growth of APR-driven breast, endometrial, and other cancers, including castration-resistant prostate cancer (CRPC) tumors.

The companion test will aim to identify which patients are most likely to respond to treatment with onapristone, based on their APR status.

Flemington, NJ-based Arno will sponsor and conduct clinical trials for the drug, while Leica will develop and validate the companion diagnostic test kit and ensure that it meets US Food and Drug Administration and other health regulatory standards required for a Phase II trial focused on endometrial cancer. The firms plan to have the drug and the IVD companion diagnostic approved and launched simultaneously.

Arno said preclinical studies have shown that approximately 40 percent of archived endometrioid cancer specimens and roughly 25 percent of breast cancer specimens were APR positive, and early findings suggest that progesterone receptor was present in CRPC specimens. Further investigation is underway to find out the frequency of APR positive tumors in CRPC specimens.