On April 9, 2020 Rexahn Pharmaceuticals terminated a nearly two-year-old agreement with Merck that paired the company’s experimental phosphorylated-p68 inhibitor with Keytruda as a potential treatment for metastatic triple-negative breast cancer (Press release, Merck & Co, APR 9, 2020, View Source [SID1234556249]).
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Rexahn disclosed the decision in a filing with the U.S. Securities and Exchange Commission this week, Seeking Alpha first reported. Rexahn said it notified Merck on April 7 of its decision to discontinue the development of RX-5902 for the treatment of metastatic triple-negative breast cancer. The two companies initially struck the agreement in 2018. At the time the deal was struck, Rexahn’s RX-5902 was already being studied as a monotherapy for triple-negative breast cancer. The companies intended to pair Keytruda with RX-5902 to treat patients with metastatic TNBC who have progressed following at least one prior treatment. Rexahn was intended to be the sponsor of the Phase II study.
In preclinical studies, RX-5902 had been shown to inhibit the growth and proliferation of multiple human cancer cell lines, including triple-negative breast cancer, decrease tumor growth in patient-derived xenograft models and potentiate the activity of immune checkpoint inhibitors and other anti-tumor agents, Rexahn said at the time of the deal.
In its disclosure this week, Rexahn provided little reason for the discontinuation of the Phase II program. The company said it had previously disclosed that it was evaluating the development strategy for RX-5902, including whether to proceed with the trial. In September, Rexahn announced it was exploring strategic alternatives to enhance shareholder value. Those options included the potential sale or licensing of assets. In that announcement, Rexahn said it would not disclose any developments of its strategy until "the evaluation of strategic alternatives has been completed or the board of directors has concluded that disclosure is appropriate or legally required."
While Rexahn has been somewhat silent on the state of its exploration of strategic alternatives, the company has continued to conduct business. In an SEC filing last month, the company said it amended its 2019 license agreement for its oncology asset RX-3117 with BioSense Global to use in Singapore, China, Hong Kong, Macau and Taiwan. BioSense initially aimed at developing the cancer treatment for China.
In February, Rexahn entered into a licensing agreement with China-based Zhejiang HaiChang Biotechnology for RX-0201, an asset that is a "nano-liposomal formulation of RX-0201 known as RX-0301, and RX-0047, a proprietary compound currently in preclinical development." HaiChang intends to develop one product comprising RX-0301 and one product comprising RX-0047, Rexahn said in the filing. Under terms of the deal, Rexahn could earn nearly $100 million if certain developmental and regulatory milestones are met.