Processa Pharmaceuticals Terminates License for Cancer Drug PCS3117, Shifts Focus to Next-Generation Capecitabine

Processa Pharmaceuticals has announced the termination of its license agreement for the anticancer asset PCS3117, citing excessive time and cost requirements to reach a meaningful milestone. The oral analog of Eli Lilly's Gemzar will be returned to Opus Genetics as part of a strategic portfolio streamlining effort.

PCS3117 Development Halted

Processa initially licensed PCS3117, also known as next-generation gemcitabine, from Opus Genetics (formerly Ocuphire Pharma) in June 2021. The company had conducted a 46-patient phase 1/2 trial in metastatic pancreatic cancer, which concluded in 2023. However, after several years of development, Processa determined that the nearest milestone for PCS3117 remained out of reach.

"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 stated in a July 1 business update.

PCS3117 was designed to be activated by a different enzyme system than Gemzar once in the body, potentially offering a treatment option for patients resistant to Gemzar. As recently as August 2024, Processa had intended to meet with the FDA to discuss the design for PCS3117's next trial.

Strategic Shift to Next-Generation Capecitabine

With the termination of the PCS3117 program, Processa is redirecting its resources to focus on another oncology asset: a modification of a precursor molecule of the approved chemotherapy 5-fluorouracil, marketed as Adrucil by Teva Pharmaceuticals. This next-generation capecitabine is currently being evaluated in a phase 2 metastatic breast cancer trial.

David Young, Ph.D., Processa's president of research and development, explained the company's strategy: "We are taking deliberate steps to focus our resources on programs with the highest potential for clinical success and commercial impact. Our approach continues to center on developing safer, more effective treatments for cancer while creating value through strategic business development and disciplined pipeline management."

In addition to next-generation capecitabine, Processa is also developing an analog of irinotecan, which is commonly used in combination with capecitabine and fluorouracil.

This portfolio realignment reflects Processa's commitment to optimizing its drug development pipeline and allocating resources to projects with the greatest potential for success in the competitive oncology market.