Processa Pharmaceuticals' Latest Updates on Drug Pipeline
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Processa Pharmaceuticals Provides Product Pipeline and Financial Update
Phase 2 trial with NGC-Cap in breast cancer underway
NGC-Cap Phase 1b trial demonstrated a favorable safety profile with preliminary anti-tumor activity
Preclinical studies demonstrated NGC-Iri delivers more cancer-killing SN-38 molecules to tumor than either irinotecan or Onivyde
Processa Pharmaceuticals, Inc. (Nasdaq: PCSA), a clinical-stage pharmaceutical company focused on developing the next generation of chemotherapeutic drugs with improved efficacy and safety, provides updates on its product pipeline, upcoming milestones, and business activities, along with financial results for the three and six months ended June 30, 2024.
“We made significant progress in advancing our three development programs year-to-date, with a particular focus on our lead candidate NGC-Cap,” said George Ng, Chief Executive Officer of Processa Pharmaceuticals. “Upon receiving FDA clearance of our NGC-Cap IND application, we initiated a Phase 2 clinical trial in metastatic breast cancer. We look forward to enrolling patients in this multicenter, open-label study and expect to have an initial data readout in mid-2025.”
Key Program Updates
Processa is dedicated to developing next-generation chemotherapies (NGC) by enhancing widely used FDA-approved oncology drugs to extend patient survival and improve quality of life. This is achieved by modifying how drugs are metabolized and distributed in the body, including their delivery to cancer cells. Additionally, Processa uses its Regulatory Science Approach, incorporating principles from FDA’s Project Optimus Oncology initiative, to optimize the benefit-risk profile of its NGC drug products.
NGC-Cap (PCS6422)
NGC-Cap is a combination of PCS6422 and capecitabine, the oral prodrug of the cancer drug 5-fluorouracil (5-FU). PCS6422 enhances the metabolism of 5-FU, leading to increased distribution to cancer cells. In July 2024, the FDA approved the Company’s IND application for a Phase 2 trial with NGC-Cap in metastatic breast cancer. Following this, Processa commenced the Phase 2 study, a global, multicenter, open-label, adaptive design trial comparing two doses of NGC-Cap to FDA-approved capecitabine in about 60 to 90 patients.
The NGC-Cap Phase 1b study revealed that partially 66.7% of evaluable patients administered one dose of PCS6422 along with seven days of capecitabine exhibited partial responses or stable disease, demonstrating promising anti-tumor activity.
PCS3117: Next-Generation Gemcitabine (NGC-Gem)
NGC-Gem is an oral analog of gemcitabine (Gemzar) that is processed by a different enzyme system, aiming to respond positively in patients who are intrinsically resistant to or develop resistance to gemcitabine. Processa is assessing NGC-Gem's potential against pancreatic and other cancers and plans discussions with the FDA regarding trial designs, including advancements in the Project Optimus initiative.
PCS11T: Next-Generation Irinotecan (NGC-Iri)
NGC-Iri is designed as an improved formulation of SN-38, the active metabolite of irinotecan, intended to enhance safety and efficacy. Recent studies showed NGC-Iri yields a significant accumulation of SN-38 in tumors while reducing exposure in non-cancerous tissues, which could provide better efficacy and a favorable side effect profile compared to traditional treatments.
Second Quarter Financial Results
In the second quarter of 2024, Processa reported research and development expenses totaling $1.7 million, unchanged from the same quarter in 2023. General and administrative expenses increased to $1.4 million compared to $1.0 million in the second quarter of last year, primarily driven by higher professional fees.
The net loss for the quarter was $3.0 million, reflecting a loss of $1.01 per share, compared to $2.6 million or $1.94 per share in the second quarter of 2023. Cash and cash equivalents were reported at $5.6 million as of June 30, 2024.
About Processa Pharmaceuticals, Inc.
Processa Pharmaceuticals is committed to developing Next Generation Chemotherapy (NGC) drugs that offer enhanced safety and efficacy. The Company focuses on modifying existing FDA-approved oncology therapies to alter drug metabolism and distribution while maintaining their cancer-killing mechanisms. By leveraging a robust oncology pipeline combined with effective regulatory strategies, Processa aims to provide better therapeutic options for cancer patients.
Frequently Asked Questions
What is the status of Processa's NGC-Cap trial?
Processa is currently conducting a Phase 2 clinical trial for NGC-Cap in metastatic breast cancer, with initial data expected in mid-2025.
What financial results did Processa announce for Q2 2024?
For Q2 2024, Processa reported a net loss of $3.0 million, with cash and cash equivalents totaling $5.6 million as of June 30, 2024.
What are NGC drugs?
NGC drugs are next-generation chemotherapies designed to enhance the efficacy and safety of existing cancer treatments by modifying their metabolism and distribution in the body.
What other drugs is Processa developing?
In addition to NGC-Cap, Processa is developing NGC-Gem, an oral analog of gemcitabine, and NGC-Iri, designed to improve the safety and efficacy of irinotecan treatments.
How does Processa approach regulatory science?
Processa employs a Regulatory Science Approach that integrates principles from initiatives like FDA’s Project Optimus to ensure a favorable benefit-risk profile for its drug candidates.
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