Processa presents two abstracts at AACR 2024 including data on NGC-Cap trial

Processa Pharmaceuticals presented two abstracts at the American Association for Cancer Research Annual Meeting 2024, including new Phase 1b data on its Next Generation Capecitabine product. The NGC-Cap Phase 1b trial evaluated ascending doses of capecitabine when combined with a fixed dose of PCS6422 in patients with advanced, relapsed, or refractory progressive gastrointestinal cancer. These patients had to relapse from or fail all other treatments. NGC-Cap demonstrated greater 5-FU exposure and lower fluoro-beta-alanine exposure with a better or similar side effect profile compared with monotherapy capecitabine. The poster presentation, titled “Next generation capecitabine in Phase 1b trial significantly increases 5-FU exposure while improving safety profile compared to capecitabine,” reported the following more recent findings: 18 patients were enrolled in the first four dose levels of capecitabine in NGC-Cap; The 5-FU exposure, expressed as the area under the 5-FU plasma concentration curve or AUC, for the two highest doses cohorts of 150 and 225 mg twice-daily NGC-Cap were 4,551 and 6,889 ng-hr/ml, respectively, which is approximately 5-10 times the AUC of 698 previously reported for a larger dose of approximately 2,250 mg twice-daily of monotherapy capecitabine; Similarly, the 5-FU maximum plasma concentrations for these two cohorts were greater at 1.5 times the Cmax of monotherapy capecitabine; As expected, with the greater 5-FU exposure for all the NGC-Cap cohorts, the incidence of anabolite related side effects was also greater than monotherapy treatment, suggesting that more drug was distributed to duplicating cancer cells and normal cells; The extremely low FBAL catabolite formation and exposure across all NGC-Cap doses resulted in the incidence of catabolite related side effects to be less with only one patient having Grade 1 hand-foot-syndrome, an FBAL related side effect often requiring dose modifications. In addition, Processa presented a second abstract at AACR titled “Application of phase 1 and pre-clinical data to assist in determining the optimal dosage regimen for cancer drugs using the principles of Project Optimus.” This abstract briefly describes the U.S. Food and Drug Administration’s Project Optimus Initiative and draft optimal dosage regimen guidance, which requires an ODR justified by a dose-ranging efficacy and safety study, as opposed to a maximum tolerated dose approach. Processa provided preclinical and Phase 1 oncology study examples to demonstrate how the exposure-response relationships for safety and efficacy can provide the recommended dose range to define and justify the optimal dosage regimen in an efficacy-safety study, in a pivotal study, and for FDA approval. The abstract also noted that Project Optimus may require alterations to the design, analysis, and interpretation of clinical trials for cancer drugs compared with what has been done in the past.