FLEMINGTON, N.J.—Biopharmaceutical company Arno Therapeutics, Inc. has announced the signing of an exclusive, worldwide license agreement with the University of Minnesota for technology related to a gene expression signature obtained from archived breast cancer tissue samples. The technique could potentially identify progesterone-stimulated pathway activation, which in turn could aid in the identification of patients most likely to benefit from treatment with onapristone, Arno’s lead compound. Onapristone is an anti-progestin therapeutic being developed to treat various men’s and women’s cancers.
Per the terms of the agreement, which was established through the University’s Office for Technology Commercialization, Arno and the University will further develop the progesterone receptor (PR) gene signature as a potential companion diagnostic for anti-progestins, including onapristone. No financial details were disclosed.
“Our agreement with the University of Minnesota offers Arno a strategic partnership with a leading academic institution and innovator in research, education and patient care in the oncology space,” Glenn Mattes, CEO of Arno Therapeutics, said in a press release. “This technology gives Arno an additional platform for identifying patients with breast cancer and other tumor types who would most likely benefit from our personalized therapy.”
Arno’s onapristone is an oral, anti-progestin hormone block that has demonstrated anti-tumor activity in patients with breast cancer in Phase 2 clinical trials. In preclinical testing, it was shown to block the activation of the progesterone receptor, which is thought to be a mechanism that slows the growth of activated progesterone receptor-driven breast, endometrial and other tumors. The gene signature is indicative of the presence of aberrant progesterone receptor activity.
“As progesterone receptors are implicated in cancer progression, we are excited by the possible outcomes resulting from investigation of the PR gene signature in breast cancer tissue samples, as illustrated by the expression pattern. The study of this gene signature may enable better, more targeted selection of patient candidates who will benefit most from anti-progestin therapeutics such as onapristone,” Carol Lange, Ph.D., professor of Medicine at the University of Minnesota, commented in a statement. “We believe that the advent of personalized medicine in oncology represents a meaningful advancement in the area of cancer therapeutics. Onapristone is specifically aimed at targeting the aberrant actions of progesterone receptors. 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.”
“Onapristone, a member of the class of anti-progestins, has the distinct ability to block the activation of the progesterone receptor. 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,” said David M. Jackson, vice president of Diagnostics at Arno Therapeutics.
This agreement comes a little over a month after Arno announced that it had enrolled the first patient in a Phase 1 dose-escalation study to evaluate onapristone in post-menopausal women with progesterone receptor-positive tumors. The study will seek to determine the recommended Phase 2 dose for the drug, as well as its overall safety profile and anti-tumor activity. Onapristone will be evaluated in sustained and immediate release formulations in up to six dose levels. Arno has selected contract research organization Biotrial for the Phase 1 study.