NGC-Cap shows enhanced cancer-killing exposure with comparable safety ahead of 2026 interim analysis
Processa Pharmaceuticals (PCSA) provided a positive clinical update on its ongoing Phase 2 study evaluating NGC-Cap, a combination of PCS6422 and capecitabine, in patients with advanced or metastatic breast cancer. Preliminary data suggest the therapy may significantly enhance cancer-fighting activity without increasing treatment-related toxicity, reinforcing the potential of the company’s Next Generation Cancer (NGC) platform.
Data from the first 16 of 19 enrolled patients indicate that NGC-Cap meaningfully increases exposure to capecitabine’s active cancer-killing metabolites compared with standard capecitabine monotherapy. Importantly, this improved pharmacologic exposure did not lead to greater severity of side effects, a critical limitation of current dosing strategies. These findings point to a more favorable therapeutic balance between efficacy and tolerability.
Dr. David Young, President of Research and Development at Processa, said the results validate the company’s core strategy. He noted that NGC-Cap appears to boost exposure to metabolites responsible for tumor cell destruction while simultaneously reducing formation of toxic catabolites, such as FBAL, which are linked to dose-limiting side effects like hand-foot syndrome (HFS).
While patients receiving NGC-Cap experienced a higher number of side effects related to increased active metabolite exposure, the severity remained comparable to those receiving capecitabine alone. Notably, exposure to FBAL was up to ten times lower in the NGC-Cap group. Consistent with this finding, HFS symptoms in the combination arm were limited to mild cases, whereas patients receiving monotherapy experienced more severe symptoms.
George Ng, Chief Executive Officer of Processa Pharmaceuticals, described NGC-Cap as a key value driver for the company and an important potential advance for patients with advanced breast cancer. He emphasized that the ability to increase therapeutic impact without worsening tolerability could represent a meaningful improvement over existing treatments.
Processa expects to complete enrollment for the formal 20-patient interim safety and efficacy analysis by the end of the first quarter of 2026, with full interim results anticipated shortly thereafter.
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