Processa Pharmaceuticals Updates on Product Pipeline and Financials

Processa Pharmaceuticals, a clinical-stage company, has provided updates on its ongoing projects, upcoming milestones, and financial results for the first half of 2024. The company's focus is on developing next-generation chemotherapeutic drugs with enhanced efficacy and safety. George Ng, CEO of Processa Pharmaceuticals, announced the initiation of a Phase 2 trial for their lead candidate, NGC-Cap, in metastatic breast cancer following FDA approval.

Processa's primary strategy involves modifying FDA-approved oncology drugs to improve their metabolism and distribution within the body, thereby enhancing patient outcomes. The company follows a Regulatory Science Approach, incorporating principles from the FDA's Project Optimus Oncology initiative to optimize the benefit-risk profile of its drug products.

The company's lead candidate, NGC-Cap, combines PCS6422 with capecitabine, a prodrug of the cancer treatment 5-fluorouracil (5-FU). PCS6422 alters 5-FU metabolism, increasing its concentration in cancer cells. In July 2024, Processa received FDA clearance for a Phase 2 trial of NGC-Cap in patients with metastatic or advanced breast cancer. This global multicenter, open-label trial will compare two doses of NGC-Cap with monotherapy capecitabine in 60 to 90 patients.

In the Phase 1b trial, NGC-Cap demonstrated increased 5-FU exposure and reduced fluoro-beta-alanine (FBAL) exposure. The trial included patients with advanced, relapsed, or refractory progressive gastrointestinal cancer who had failed other treatments. Results showed a promising safety profile and preliminary anti-tumor activity, with 66.7% of patients achieving partial responses or stable disease and progression-free survival ranging from 5 to 11 months. Further data presented at the American Association for Cancer Research (AACR) Annual Meeting 2024 supported the potential of NGC-Cap to deliver higher 5-FU concentrations to cancer cells at lower doses, minimizing FBAL-related side effects.

Another key candidate, NGC-Gem, is an oral analog of gemcitabine (Gemzar®) designed to be activated by a different enzyme system. This drug has the potential to benefit patients resistant to or who develop resistance to gemcitabine. Processa plans to meet with the FDA in late 2024 or early 2025 to discuss trial designs and the implementation of Project Optimus initiatives.

Processa is also advancing NGC-Iri, an analog of SN38, the active metabolite of irinotecan. NGC-Iri is designed to improve efficacy and safety for cancers treated with irinotecan. Recent studies showed that NGC-Iri resulted in higher SN-38 accumulation in tumors and lower accumulation in non-cancerous tissues, suggesting a better safety-efficacy profile. Preclinical data presented at AACR 2024 supported the potential of NGC-Iri to determine the optimal dosage regimen using FDA’s Project Optimus guidelines.

Financially, Processa reported research and development expenses of $1.7 million for the second quarter of 2024, consistent with the previous year. General and administrative expenses increased to $1.4 million, primarily due to higher professional fees. The net loss for Q2 2024 was $3.0 million, compared to $2.6 million in Q2 2023. Cash and cash equivalents stood at $5.6 million as of June 30, 2024.

Processa Pharmaceuticals is committed to advancing its NGC drug pipeline, focusing on improving the safety and efficacy of existing cancer treatments. The company's strategy includes leveraging FDA-approved therapies and applying its Regulatory Science Approach to provide better therapeutic options for cancer patients.