FDA Clears IND for Processa's Phase 2 Trial of NGC-Cap in Breast Cancer

HANOVER, Md., July 30, 2024 — Processa Pharmaceuticals, Inc., a clinical-stage pharmaceutical company, recently received clearance from the U.S. Food and Drug Administration (FDA) for its Investigational New Drug (IND) application for Next Generation Capecitabine (NGC-Cap). This approval allows the company to commence a Phase 2 clinical trial targeting patients with advanced or metastatic breast cancer.

David Young, President of Research and Development at Processa, highlighted the significance of this milestone by stating, “We are proud to achieve this significant milestone for NGC-Cap and look forward to entering the clinic for the treatment of advanced or metastatic breast cancer, where capecitabine is a standard of care.” Young underscored that prior Phase 1b studies indicated NGC-Cap's superiority in potency compared to monotherapy capecitabine, offering up to 5-10 times more 5-fluorouracil exposure to cancer cells. This heightened exposure translated into improved efficacy while maintaining a similar or better safety profile.

Capecitabine remains one of the most commonly used chemotherapy drugs for solid tumors. However, Young noted that a more effective treatment with fewer or less severe side effects is still needed. He expressed optimism that NGC-Cap could fill this gap.

Breast cancer continues to be the second most prevalent cancer and a leading cause of cancer-related deaths, with over 2 million new cases and more than 665,000 deaths recorded globally in 2022. The survival rate for those diagnosed with metastatic breast cancer remains approximately 30% over five years.

The upcoming Phase 2 study will be a global, multicenter, open-label trial involving 60 to 90 patients with advanced or metastatic breast cancer. Using an adaptive design, the study will compare two different doses of NGC-Cap against FDA-approved monotherapy capecitabine. The objective is to assess the safety and efficacy profiles of NGC-Cap, establish optimal dosage regimens as per the FDA Project Optimus Initiative, and explore the potential for personalizing NGC-Cap therapy. The first patient enrollment is anticipated in the third quarter of 2024.

About Capecitabine Administered with PCS6422 (NGC-Cap)

NGC-Cap integrates PCS6422, Processa’s irreversible dihydropyrimidine dehydrogenase (DPD) enzyme inhibitor, with low doses of capecitabine. Capecitabine, an oral prodrug of 5-FU, remains one of the most widely used chemotherapy drugs for treating solid tumors. After oral ingestion, capecitabine converts into 5-FU, which subsequently metabolizes into cancer-killing molecules called anabolites and side-effect-causing molecules called catabolites. The DPD enzyme is crucial in the undesirable conversion of 5-FU into catabolites, thereby reducing tumor exposure to 5-FU and its effective anabolites.

The Phase 1b study of NGC-Cap evaluated varying doses of capecitabine combined with a fixed dose of PCS6422 in patients with advanced, relapsed, or refractory progressive gastrointestinal tract cancer. These patients had exhausted all other treatment options. Results showed that NGC-Cap achieved greater 5-fluorouracil (5-FU) exposure and lower fluoro-beta-alanine (FBAL) exposure with a similar or better side effect profile compared to monotherapy capecitabine. Preliminary anti-tumor activity was also observed, with partial responses or stable disease seen in 66.7% of evaluable patients.

About Processa Pharmaceuticals, Inc.

Processa Pharmaceuticals is a clinical-stage company focused on advancing Next Generation Chemotherapy (NGC) drugs that aim to improve both the safety and efficacy of existing cancer treatments. By modifying the metabolism and distribution of FDA-approved oncology therapies while preserving their cancer-killing mechanisms, Processa aims to develop more effective and better-tolerated treatment options through an efficient regulatory pathway.

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