NGC-irinotecan (PCS-11T) / Teva, Aposense, Processa Pharma - LARVOL DELTA

Preclinical Project Optimus dose escalation of SN-38 pro-drug PCS11T. (ASCO 2025) - "11T efficacy of 100% TGI was maintained from MTD to 25% MTD while the adverse events (AEs) continually decreased suggesting that the ODR is not the MTD but likely lower than the MTD. This differs from Iri where both efficacy and AEs decrease with decreasing dose making the MTD a potential ODR. The difference in the dose-efficacy vs dose-safety relationships may be because 11T selectively enhances tumor permeability and prolongs SN-38 tumor exposure."

Preclinical • Colorectal Cancer • Oncology • Solid Tumor

Processa Pharmaceuticals Announces Presentation and Publication of Three Abstracts at 2025 ASCO Annual Meeting (GlobeNewswire) - "Processa Pharmaceuticals, Inc...today announced the acceptance of three abstracts for the 2025 American Society of Clinical Oncology (ASCO) Annual Meeting, taking place May 30 to June 3, 2025, at McCormick Place in Chicago, Illinois. The abstracts highlight Processa’s pipeline of Next Generation Cancer (NGC) drug candidates, including PCS6422 (NGC-Cap) and PCS11T (NGC-Iri), showcasing both preclinical and clinical advances."

Clinical data • Preclinical • Breast Cancer

Processa Pharmaceuticals Provides Product Pipeline and Financial Update (GlobeNewswire) - "Processa is evaluating the potential of NGC-Gem in patients with pancreatic and other cancers, as well as ways to identify patients who are more likely to respond to NGC-Gem than gemcitabine alone. The Company plans to meet with the FDA in late 2024 or early 2025 to discuss potential trial designs, including implementation of the Project Optimus initiative....The Company is currently evaluating the manufacturing process and potential sites for NGC-Iri. In addition, Processa is defining the potential paths to approval, which include defining the target patient population and the type of cancer, with the expectation to conduct IND-enabling toxicology studies in 2025."

FDA event • Preclinical • Gastrointestinal Cancer • Oncology • Pancreatic Cancer • Solid Tumor

Processa Pharmaceuticals Announces Positive Preclinical Data for NGC-Iri (GlobeNewswire) - "Processa Pharmaceuticals, Inc...announces positive data from preclinical studies that support the potential for NGC-Iri to have improved efficacy and a better side effect profile compared with the commonly used FDA-approved cancer treatments irinotecan and Onivyde (the liposomal formulation of irinotecan)....Accumulation of SN-38 in the tumor compared with other tissues, such as muscle, was greater after NGC-Iri administration than after irinotecan or Onivyde administration, as demonstrated by the tumor-to-muscle ratio of approximately 200 for NGC-Iri and less than 15 for irinotecan and Onivyde; More SN-38 accumulated in the tumor after NGC-Iri administration than after irinotecan or Onivyde administration, as demonstrated by the tumor-to-plasma ratio being approximately 10 for NGC-Iri and less than 7 for irinotecan and Onivyde."

Preclinical • Melanoma • Oncology • Skin Cancer • Solid Tumor