On June 17, 2021 Processa Pharmaceuticals, Inc. (NASDAQ: PCSA) reported that it has entered into a licensing agreement with Ocuphire Pharma, Inc. (NASDAQ: OCUP) to license in RX-3117(Press release, Processa Pharmaceuticals, JUN 17, 2021, View Source [SID1234584119]). RX-3117 is an oral, anticancer agent with an improved pharmacological profile relative to gemcitabine and other nucleoside analogs. Rx-3117 has a family of patents extending into 2036 as well as U.S. Food and Drug Administration (FDA) Orphan Designation for the treatment of Pancreatic Cancer. Processa will evaluate the potential benefit of RX-3117 for patients with such cancers as pancreatic or non-small cell lung cancer.
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Under the terms of the agreement, Processa has an exclusive worldwide license (excluding China), to develop, manufacture, use, commercialize and sublicense RX-3117.
Processa will be developing biomarker assays to identify those patients who will most likely benefit from this targeted therapy. Prior to conducting a pivotal trial, Processa will first conduct a Phase 2b trial in 2022 to assess the correlation of the biomarker measurements with the clinical benefit-risk of RX-3117 in patients with pancreatic cancer or non-small cell lung cancer.
We are excited to expand our oncology portfolio, while providing an important solution for patients with pancreatic and non-small cell lung cancer," said Dr. David Young, Chief Executive Officer of Processa Pharmaceuticals. "The asset aligns with our mission to identify and bring to market better and safer drugs for patients who need treatment options to improve their survival and/or quality of life. From our Phase 2b trial, we expect to obtain biomarker data that will identify patients who will benefit the most from this drug while significantly increasing the probability of a successful Phase 3 trial.
"The RX-3117 program is a legacy asset from our merger with Rexahn Pharmaceuticals last year, and outside our core ophthalmology competency. We are very pleased to establish this partnership with Processa which has the expertise needed to further develop RX-3117. The economic terms of the license will be 75% attributed to the holders of the Rexahn Contingent Value Rights and 25% attributed to Ocuphire," said Mina Sooch, Chief Executive Officer for Ocuphire Pharma.