- FDA authorizes Expanded Access Program (EAP) for MNPR-101-Zr and MNPR-101-Lu in advanced cancers.
- Program targets aggressive cancers, including triple-negative breast, pancreatic, and colorectal cancer.
- Collaboration with EDNOC, a recognized Radiopharmaceutical Therapy Center of Excellence.
Monopar Therapeutics Inc. (MNPR, Financial), a clinical-stage biopharmaceutical company focused on innovative treatments, has received FDA authorization for an Expanded Access Program (EAP) for their investigational agents MNPR-101-Zr and MNPR-101-Lu. These agents are designed to target aggressive cancers such as triple-negative breast, pancreatic, and colorectal cancers, by utilizing the urokinase plasminogen activator receptor (uPAR) as a molecular target.
The EAP is now open for enrollment at the Excel Diagnostics and Nuclear Oncology Center (EDNOC) in Houston, Texas. EDNOC, designated as a Radiopharmaceutical Therapy Center of Excellence by the Society of Nuclear Medicine and Molecular Imaging (SNMMI), will conduct the program under the supervision of Dr. Ebrahim S. Delpassand. This initiative builds on Monopar's ongoing Phase 1 clinical trials in Australia initiated last year.
By providing compassionate use access, the program aims to deliver targeted radiopharmaceutical therapy to patients with limited treatment options, while concurrently gathering additional real-world clinical data. This dual-track development approach exemplifies Monopar's strategy to advance their radiopharmaceutical pipeline.
