Arno Therapeutics said today it licensed from the University of Minnesota a cancer diagnostic technology designed to identify patients most likely to benefit from Arno's lead compound, a drug candidate now in a Phase I study.
The technology is related to a gene expression signature derived from archived breast cancer tissue samples. The platform has potential for detecting progesterone-stimulated pathway activation and, in turn, helping find patients who would benefit from treatment with onapristone, Arno’s anti-progestin drug for men's and women's cancers.
Under an exclusive worldwide license agreement, Arno will further develop the PR gene signature as a potentially predictive companion diagnostic for onapristone and other anti-progestins. The agreement enables the possibility of incorporating such a companion diagnostic test into ongoing and future clinical studies of onapristone.
Onapristone is currently being evaluated in a phase I clinical trial in women who have progesterone receptor expressing tumors in France. The trial – which enrolled its first patient in January – is designed to determine the drug’s overall safety profile and identify a recommended dose for new Phase II studies. The oral, anti-progestin hormone blocker has been shown in previous Phase II clinical trials to exhibit anti-tumor activity in patients with breast cancer.
In pre-clinical testing, onapristone has been shown to block activation of the progesterone receptor (PR), believed to inhibit the growth of APR-driven breast, endometrial and other tumors. Tests for the activated form of the progesterone receptor or APR could function as a biomarker of anti-progestin activity, as detected by a companion diagnostic under development.
“We believe this license agreement will enable Arno's diagnostic strategy to identify and develop multiple analytical methods to identify those patients whose tumors are APR-positive and may therefore benefit from targeted onapristone therapy," David M. Jackson, vp, diagnostics for Arno, said in a statement.
Originally developed by Schering, onapristone showed promising anti-tumor activity, as well as transient elevated liver function in earlier clinical studies in Europe on post-menopausal women with breast cancer. Arno began developing the drug in 2012 under license from Invivis Pharmaceutical, and aims to develop onapristone for a variety of tumors, including breast and endometrial cancer.
“The potential development of a companion diagnostic for Arno's lead compound from this technology represents a significant step forward in our ability to truly realize the potential of personalized medicine," added Carol Lange, Ph.D., professor of medicine at University of Minnesota.