Processa Pharmaceuticals Begins Phase 2 Trial of NGC-Cap in Metastatic Breast Cancer

Processa Pharmaceuticals, Inc. has commenced dosing the first patient in a Phase 2 clinical trial targeting advanced or metastatic breast cancer with its experimental drug, NGC-Cap. The primary objective of this clinical trial is to assess the safety and efficacy of NGC-Cap compared to the conventional chemotherapeutic agent capecitabine.

NGC-Cap, a combination of capecitabine and PCS6422, aims to enhance treatment by mitigating adverse side effects associated with both capecitabine and the closely related 5-fluorouracil (5-FU). PCS6422 is an irreversible inhibitor of the dihydropyrimidine dehydrogenase (DPD) enzyme, which plays a crucial role in the conversion of 5-FU into harmful catabolites. By inhibiting this enzyme, NGC-Cap seeks to increase the concentration of cancer-fighting anabolites while reducing side effects.

David Young, the President of Research and Development at Processa, views the initiation of dosing in this Phase 2 trial as a pivotal development. Young anticipates that the Phase 2 trial will build on the positive findings from the earlier Phase 1b study. The company expects to share interim analysis results by mid-2025.

The global, multicenter, open-label Phase 2 trial (NCT06568692) is designed with an adaptive structure to compare two different doses of NGC-Cap against FDA-approved monotherapy capecitabine. The study will enroll approximately 60 to 90 patients with advanced or metastatic breast cancer. The trial's goals are to determine the safety and effectiveness of NGC-Cap, establish the optimal dosing regimen, and explore the potential for personalized therapy. This study aligns with the FDA Project Optimus Initiative, which requires a thorough evaluation of dosage regimens to maximize therapeutic benefits and minimize adverse effects.

Currently, three clinical trial sites have received institutional review board approval to participate, with more in the pipeline. Processa aims to activate around 30 sites globally to ensure a comprehensive and diverse patient pool.

Breast cancer remains a significant health challenge worldwide. It is the second most common cancer and a leading cause of cancer-related mortality. In 2022, over 2 million new cases were diagnosed, and more than 665,000 deaths were recorded globally. The five-year survival rate for metastatic breast cancer stands at approximately 30%.

Capecitabine, the principal component of NGC-Cap, is a well-established chemotherapy drug that converts into 5-FU in the body. 5-FU then metabolizes into anabolites that target cancer cells and catabolites that cause adverse side effects. By incorporating PCS6422, NGC-Cap aims to minimize these side effects, thereby enhancing the therapeutic profile of capecitabine.

Processa Pharmaceuticals focuses on developing the next generation of chemotherapeutic drugs that offer improved safety and efficacy. Their proprietary approach involves modifying existing FDA-approved oncology treatments to alter their metabolism and distribution while retaining their cancer-killing mechanisms. This strategy aims to create more effective and better-tolerated therapy options for cancer patients, utilizing an efficient regulatory pathway.

By advancing its novel oncology pipeline, Processa aims to offer cancer patients more effective therapies with improved tolerability, ultimately enhancing patient outcomes. This ongoing Phase 2 trial represents a significant step in that direction.