Processa Pharmaceuticals has decided to discontinue work on its cancer drug candidate PCS3117 and return the asset to its original owner, Opus Genetics. The company cited the long timeline and high financial requirements to reach the next development milestone as reasons for ending the license agreement.
PCS3117 is an oral compound modeled on Eli Lilly’s chemotherapy drug Gemzar. Unlike Gemzar, PCS3117 is metabolized by a different enzyme system, potentially allowing it to benefit patients with resistance to Gemzar. Processa had acquired exclusive worldwide rights to develop and market PCS3117 outside China through a licensing agreement with Opus Genetics, then known as Ocuphire Pharma, in June 2021.
Following the agreement, Processa conducted a 46-patient phase 1/2 trial of PCS3117 in metastatic pancreatic cancer. That study concluded in 2023. In August 2024, the company indicated plans to consult with the U.S. Food and Drug Administration regarding the design of a subsequent clinical trial, with discussions expected to occur either later that year or in early 2025. However, the company has now decided not to proceed further.
The decision is part of a broader effort by Processa to streamline its development portfolio and concentrate on drug candidates deemed to have greater potential for clinical and commercial progress. Among those is a modified version of a precursor to 5-fluorouracil, a chemotherapy drug marketed by Teva Pharmaceuticals under the name Adrucil. This updated compound, which Processa refers to as next-generation capecitabine, is currently being tested in a phase 2 study in patients with metastatic breast cancer.
Commenting on the company’s shift in focus, David Young, Ph.D., president of research and development at Processa, said, “We are taking deliberate steps to focus our resources on programs with the highest potential for clinical success and commercial impact.” He added that the company’s strategy remains centered on enhancing safety and effectiveness in cancer treatments while pursuing business development opportunities and managing its pipeline carefully.
In addition to the next-generation capecitabine candidate, Processa is developing an analog of irinotecan, another chemotherapy agent often administered alongside capecitabine and 5-fluorouracil.
Meanwhile, Opus Genetics, the original holder of PCS3117, has undergone significant changes of its own. The company, previously Ocuphire, came into possession of PCS3117 through its 2020 merger with Rexahn Pharmaceuticals. In 2024, it rebranded as a gene therapy-focused entity following its acquisition of Opus Genetics, adopting the name and pivoting its attention to inherited retinal diseases.
