The partnership will assess Rexahn’s RX-5902 and Merck’s anti-PD-1 therapy in a phase 2 study in patients with metastatic triple negative breast cancer (TNBC).
The trial has been designed to assess the safety and efficacy of the combination of RX-5902 and Keytruda in patients with metastatic TNBC who have progressed following at least one prior treatment.
As per terms of the deal, Rexahn will sponsor the RX-5902 and Keytruda study.
Rexahn Pharmaceuticals CEO Peter Suzdak said: “Rexahn is excited to announce this collaboration with Merck, an established leader in the field of immuno-oncology.”
“RX-5902 has both antitumor and immune-modulatory effects and augments the efficacy of checkpoint inhibitors in animal models.
“Based on the mechanism of action of RX-5902 and our observations in preclinical studies, we are optimistic that the combination of RX-5902 with Keytruda may provide meaningful clinical benefit in patients with metastatic triple negative breast cancer – a cancer that is notoriously difficult to treat.”
Rexahn’s RX-5902 is an orally administered, potential first-in-class and small molecule inhibitor of phosphorylated-p68 (P-p68).
The P-p68 is selectively overexpressed in cancer cells and will not appear in normal tissue. It modulates the activity of the β-catenin/Wnt pathway and plays a significant role in tumor progression, metastasis and tumor immunogenicity.
In preclinical studies, RX-5902 was demonstrated to inhibit the growth and proliferation of multiple human cancer cell lines, including triple negative breast cancer.
It also showed to decrease tumor growth in patient derived xenograft models and potentiate the activity of immune checkpoint inhibitors and other anti-tumor agents.
At present, RX-5902 is being assessed as monotherapy in a phase 2 clinical trial in patients with metastatic TNBC.
Rexahn is a clinical stage biopharmaceutical firm engaged in the development of novel and targeted therapeutics for the treatment of cancer.
The company’s other oncology product candidate, RX-5902, is also in phase 2 clinical development. It also has additional compounds in preclinical development, including RX-0201.