Processa Pharmaceuticals Reports Progress Update On Ongoing Phase 2 Trial In Metastatic Breast Cancer

Processa Pharmaceuticals, Inc., a clinical-stage biopharmaceutical company focused on developing Next Generation Cancer therapies, has shared a clinical update from its ongoing Phase 2 study of NGC-Cap in patients with advanced or metastatic breast cancer. NGC-Cap is a combination treatment made up of PCS6422 and capecitabine, a commonly used chemotherapy drug. The update is based on data from the first 16 of 19 patients currently enrolled in the study. These early results show that NGC-Cap significantly increases patient exposure to the active capecitabine metabolites responsible for killing cancer cells. 

Importantly, this higher exposure was achieved without increasing the severity of side effects when compared with standard capecitabine treatment given alone, known as monotherapy capecitabine or Mono-Cap. This balance between higher drug activity and manageable safety reflects the core goal of Processa’s Next Generation Cancer platform, which aims to improve the effectiveness of existing cancer drugs while minimizing treatment-limiting toxicity. Processa plans to conduct a full interim analysis once 20 patients have been enrolled in the study. This analysis will include a more comprehensive review of both efficacy and safety data and is expected to be available in early 2026.

According to Dr. David Young, President of Research and Development at Processa, the emerging data continue to support the company’s Next Generation Cancer strategy. He explained that combining capecitabine with PCS6422 appears to increase exposure to the metabolites that actively destroy cancer cells, while at the same time reducing exposure to breakdown products associated with dose-limiting side effects. One of the most common and challenging toxicities linked to standard capecitabine treatment is hand-foot syndrome, and the current findings suggest NGC-Cap may help limit this risk without compromising treatment intensity.

George Ng, Chief Executive Officer of Processa Pharmaceuticals, said the company believes NGC-Cap is showing a distinct and potentially meaningful pharmacologic profile as the study moves toward its planned interim analysis. He noted that improving the therapeutic index of capecitabine-based therapy could represent a significant advancement for patients with advanced or metastatic breast cancer. He also described the program as an important value driver for the company and a promising opportunity to address an unmet need in this patient population.

Overall, the preliminary Phase 2 results suggest that NGC-Cap may enable patients to receive higher levels of the most effective cancer-killing components of capecitabine therapy without experiencing increased severity of side effects typically seen with standard treatment. Processa believes this improved balance between potential efficacy and tolerability could play a key role in enhancing treatment outcomes for patients with advanced breast cancer.