Monopar Administers First Dose of MNPR-101-Lu

WILMETTE, Ill., Dec. 05, 2024 – Monopar Therapeutics Inc. (Nasdaq: MNPR), a biotech company in the clinical stage of development, has announced the first administration of MNPR-101-Lu—a pioneering radiopharmaceutical therapeutic. This treatment couples MNPR-101, an antibody specifically targeting the urokinase plasminogen activator receptor (uPAR), with the radioisotope lutetium-177. uPAR plays a role in tumor advancement and spread and is present in some of the most severe cancers such as pancreatic, ovarian, triple-negative breast, and colorectal cancers.

The MNPR-101-Lu intravenous infusion was administered under a compassionate use protocol to a patient with metastatic pancreatic cancer in the United States. The treatment was preceded by imaging the cancer using MNPR-101-Zr, a zirconium-89-based imaging agent connected to MNPR-101, which revealed uPAR expression through PET/CT scanning. The infusion was well-received by the patient, with no serious adverse reactions reported.

Chandler Robinson, MD, the Chief Executive Officer of Monopar, expressed optimism, citing promising clinical data from MNPR-101-Zr's biodistribution and dosimetry studies. These earlier results have fueled anticipation for the therapeutic potential of MNPR-101-Lu in providing benefits to urgently needing cancer patients.

Andrew Cittadine, Chief Operating Officer of Monopar, highlighted the significance of the event, suggesting it might be the first instance globally of a patient receiving a uPAR-targeted therapeutic radiopharmaceutical. Monopar is actively registering participants in two Phase 1 clinical trials in Australia, one for imaging using MNPR-101-Zr and another for treating advanced solid tumors with MNPR-101-Lu. Details regarding the MNPR-101-Lu Phase 1a trial can be found under ClinicalTrials.gov identifier NCT06617169, while further information on the MNPR-101-Zr imaging and dosimetry clinical trial is listed under identifier NCT06337084.

Monopar Therapeutics Inc. is dedicated to developing innovative treatments for conditions with unmet medical needs. Among its projects is ALXN-1840 for Wilson disease, which has successfully completed a Phase 3 trial. The company is also advancing radiopharmaceutical programs including MNPR-101-Zr and MNPR-101-Lu, both in Phase 1 trials, and MNPR-101-Ac225, which is in the late preclinical stage for cancer treatment. For more information about Monopar's endeavors, visit their official website.