After several years of development, Processa Pharmaceuticals has determined that the nearest milestone for anticancer asset PCS3117 is still too far away. Instead, the biotech is handing the oral analog of Eli Lilly’s Gemzar back to Opus Genetics.
“After determining that the time and cost required to advance PCS3117 to a meaningful milestone would be too high, Processa has terminated the license agreement,” the company said in a July 1 business update.
The portfolio streamlining is meant to help Processa focus on another oncology asset, a modification of a precursor molecule of approved chemotherapy 5-fluorouracil, sold as Adrucil by Teva Pharmaceuticals. Processa is currently enrolling patients in a phase 2 metastatic breast cancer trial for this candidate, called next-generation capecitabine, according to the release.
“We are taking deliberate steps to focus our resources on programs with the highest potential for clinical success and commercial impact,” David Young, Ph.D., Processa’s president of research and development, said in the release. “Our approach continues to center on developing safer, more effective treatments for cancer while creating value through strategic business development and disciplined pipeline management.”
Processa first licensed PCS3117 from Opus—then known as Ocuphire Pharma—in June 2021. Under the terms of that deal, Processa gained the exclusive worldwide right to develop and commercialize PCS3117 outside China. After securing the asset, Processa ran a 46-patient phase 1/2 trial in metastatic pancreatic cancer that wrapped up in 2023.
PCS3117, known as next-generation gemcitabine, is turned into its active form by a different enzyme system than Gemzar once in the body, according to Processa. This means the candidate could be used in patients who have resistance to Gemzar. Processa said in August 2024 that it intended to convene with the FDA to discuss the design for PCS3117’s next trial later that year or in early 2025.
For its part, Occuphire only acquired the asset through a 2020 merger with Rexahn Pharmaceuticals. In 2024, Ocuphire transformed itself into a gene therapy outfit through the acquisition of Opus Genetics, adopting the latter’s name and launching a focus on inherited retinal diseases.
Aside from next-gen capecitabine, Processa also has an analog of irinotecan, which is commonly used in combination with capecitabine and fluorouracil, in development.