Shares of Processa Pharmaceuticals Inc. (NASDAQ:PCSA) jumped 23.8% on Wednesday after the company reported early Phase 2 clinical data indicating that its Next Generation Cancer (NGC) therapy achieved higher exposure to cancer-fighting metabolites while maintaining a safety profile comparable to existing treatments.
The clinical-stage biotech company said results from 16 of the 19 patients enrolled so far show that NGC-Cap—a combination of PCS6422 and capecitabine—significantly increases exposure to the active, cancer-killing metabolites of capecitabine without worsening overall side effects relative to standard capecitabine monotherapy.
Patients treated with NGC-Cap also demonstrated markedly reduced exposure to FBAL, a catabolite metabolite linked to hand-foot syndrome (HFS). FBAL levels were reported to be as much as ten times lower than those observed in patients receiving capecitabine alone. Although a similar proportion of patients in both groups experienced HFS, symptoms in the NGC-Cap group were limited to mild cases, compared with more severe manifestations among patients on monotherapy.
“These emerging data continue to validate the central premise of our Next Generation Cancer strategy,” said Dr. David Young, President of Research and Development at Processa. “NGC-Cap appears to meaningfully increase exposure to the capecitabine metabolites responsible for killing cancer cells, while reducing exposure to the catabolite metabolites associated with dose-limiting toxicity.”
Processa said it remains on schedule to conduct a formal interim analysis of safety and efficacy data from the first 20 patients in early 2026. The ongoing study is assessing NGC-Cap in individuals with advanced or metastatic breast cancer.
The company expects to complete enrollment of the final patient required for the interim analysis by the end of the first quarter of 2026, in line with the study’s protocol.