Processa Pharmaceuticals Reports Positive Preclinical Data for NGC-Iri

Processa Pharmaceuticals, Inc. recently shared promising preclinical data underscoring the potential of their Next Generation irinotecan (NGC-Iri) as a superior cancer treatment. NGC-Iri, a novel prodrug of SN-38—the active anticancer metabolite of irinotecan—shows enhanced efficacy and a more favorable side-effect profile compared to current FDA-approved therapies such as irinotecan and Onivyde®.

In research utilizing the human melanoma xenograft mouse model, SN-38 accumulation in tumor tissue, plasma, and other tissues was scrutinized following administration of NGC-Iri, irinotecan, and Onivyde®. In the studies, mice received equivalent doses of SN-38, enabling a direct comparison of the different treatment modalities.

Key findings indicated that NGC-Iri administration resulted in significantly higher concentrations of SN-38 in tumor tissues relative to other non-cancerous tissues like muscle. The tumor-to-muscle ratio for NGC-Iri was approximately 200, compared to less than 15 for both irinotecan and Onivyde®. Additionally, the tumor-to-plasma ratio was around 10 for NGC-Iri, versus less than 7 for irinotecan and Onivyde®. Conversely, the muscle-to-plasma ratio was notably lower for NGC-Iri (less than 0.10) compared to irinotecan and Onivyde® (greater than 0.4), suggesting a reduced accumulation in non-cancerous tissues.

Dr. David Young, President of Research and Development at Processa Pharmaceuticals, highlighted the significant side effects associated with existing treatments irinotecan and Onivyde®, which often prevent patients from completing their therapy regimens. He emphasized that NGC-Iri’s ability to deliver more SN-38 directly to tumors, with decreased exposure to healthy tissues, could translate to better efficacy and fewer side effects, potentially offering a more favorable alternative for cancer patients.

Currently, Processa Pharmaceuticals is mapping out the regulatory trajectory for NGC-Iri, which includes pinpointing the specific patient demographics and cancer types to present to the FDA. Updates regarding the regulatory pathway and timeline will be provided once these parameters are established.

Irinotecan is extensively utilized for various solid tumors, including colorectal, pancreatic, ovarian, and lung cancers. It serves as a first-line therapy in combination with other chemotherapeutic agents for metastatic colon and rectal cancers and extensive-stage small cell lung cancer (SCLC). It is also employed as a second or third-line therapy for an array of other solid tumors, such as metastatic pancreatic, gastric, esophageal, breast cancers, and relapsed or refractory SCLC. Despite its severe side effects, in 2021, Medicare reported over 1.8 million doses of irinotecan and Onivyde® being administered.

NGC-Iri aims to enhance the pharmacokinetic profile of SN-38, ensuring it is preferentially delivered to cancer cells over normal cells. A distinct molecule is attached to SN-38, making it more attracted to the internal electric field of cancer cell membranes. This results in the creation of intra-membrane prodrug depots of NGC-Iri. Animal studies have demonstrated that NGC-Iri not only preferentially targets cancer cells but also extends the half-life of SN-38. Furthermore, SN-38 derived from NGC-Iri accumulates more in cancer cells and less in other tissues compared to irinotecan and Onivyde®. Dose-ranging studies in the human melanoma xenograft mouse model revealed a spectrum of doses with similar efficacy but differing safety profiles.

Processa Pharmaceuticals, Inc. is dedicated to developing Next Generation Chemotherapy (NGC) drugs with enhanced safety and efficacy. By altering the metabolism and distribution of existing FDA-approved oncology drugs while maintaining their cancer-killing mechanisms, Processa aims to offer more effective and tolerable treatments for cancer patients through an efficient regulatory approach.