Monopar and EDNOC Announce Expanded Access Program for MNPR-101-Zr and MNPR-101-Lu in Advanced Cancers

Core Viewpoint - Monopar Therapeutics has received FDA authorization for the Expanded Access Program (EAP) for investigational imaging agent MNPR-101-Zr and therapeutic agent MNPR-101-Lu, aimed at patients with advanced solid tumors [1][2][3] Group 1: Expanded Access Program (EAP) - The MNPR-101 EAP is now open for enrollment at Excel Diagnostics and Nuclear Oncology Center (EDNOC) in Houston, Texas, targeting patients with advanced solid tumors [2][5] - EAPs provide a pathway for patients with serious or life-threatening conditions to access investigational products outside of clinical trials when no satisfactory alternative treatments are available [5] Group 2: Product Details - MNPR-101 is a proprietary antibody targeting the urokinase plasminogen activator receptor (uPAR), expressed in various tumor types including pancreatic, breast, and colorectal cancers [6] - MNPR-101-Zr is designed for imaging advanced cancers, while MNPR-101-Lu is an investigational treatment for advanced solid cancers [6] Group 3: Company Background - Monopar Therapeutics is a clinical-stage biopharmaceutical company focused on developing innovative treatments for unmet medical needs, including late-stage programs for Wilson disease and radiopharmaceuticals [7] - The company is advancing its radiopharmaceutical pipeline, which includes Phase 1 clinical trials for MNPR-101-Zr and MNPR-101-Lu [3][7] Group 4: Collaboration and Expertise - The EAP will be conducted under the supervision of Dr. Ebrahim S. Delpassand, a renowned investigator and medical director at EDNOC, which is recognized as a Radiopharmaceutical Therapy Center of Excellence [2][4][9] - The collaboration aims to provide access to therapies targeting difficult-to-treat cancers, marking a promising advancement in radioligand therapy [4]