As of May 30, 2025, there are no new data reports from Processa Pharmaceuticals presented at the 2025 American Society of Clinical Oncology (ASCO) Annual Meeting regarding their cancer drug development. However, the company has made notable strides in ongoing cancer drug trials, particularly with their NGC-Cap therapy.
In October 2024, Processa kicked off a Phase 2 clinical trial for NGC-Cap, a drug combining PCS6422 and capecitabine, targeted at patients with advanced or metastatic breast cancer. This trial aims to assess the effectiveness of two different doses of NGC-Cap against the standard monotherapy capecitabine. Earlier in July 2024, the FDA granted clearance for Processa's Investigational New Drug application, paving the way for this trial's initiation. Significant positive data was also shared in April 2024 at the American Association for Cancer Research (AACR) Annual Meeting, showing enhanced 5-FU exposure and a favorable safety profile.
Processa Pharmaceuticals has been proactive in its strategic approach. In January 2024, they successfully completed a Phase 1b safety evaluation, which helped establish recommended doses for the Phase 2 trial. Looking ahead, Dr. David Young, President of Research & Development at Processa, planned to present at the World Orphan Drug Congress USA 2025. This presentation will delve into applying FDA's Project Optimus principles to both oncology and rare disease treatment strategies, as reported by Nasdaq.