Monopar Releases Initial Data on First Patient in MNPR-101-Zr Phase 1 Radiopharma Trial

Monopar Therapeutics Inc., a clinical-stage radiopharmaceutical company listed on Nasdaq under the ticker MNPR, has announced the successful administration of their uPAR-targeted imaging radiopharmaceutical MNPR-101-Zr to the first patient in an open-label Phase 1 clinical trial. The trial focuses on imaging and dosimetry, a technique used to measure and assess radiation doses absorbed by tissues.

During this initial phase, MNPR-101-Zr was well-received by the patient with no significant adverse reactions observed through the last imaging timepoint. Preliminary data from the trial indicated that the pharmacokinetics and biodistribution of MNPR-101-Zr showed a low radiation dose impact on healthy tissues, aligning with prior preclinical biodistribution data. The dosimetry analysis revealed that the radiation absorption in organs was within accepted safety limits, with the dose to red bone marrow being approximately 14 mGy—significantly less than the generally accepted limit of 2-to-3 Gy.

Moreover, no unexpected or excessive uptake of MNPR-101-Zr was noted in critical organs throughout the patient’s imaging period. The patient involved in this first administration has a metastatic disease from a cancer type not typically associated with high uPAR expression. The trial aims to include patients with cancers known to exhibit high levels of uPAR as well as those with unknown uPAR expression levels to better understand MNPR-101-Zr’s tumor uptake profile.

In response to the early findings, Andrew Cittadine, Chief Operating Officer of Monopar, expressed confidence in the ongoing Phase 1 study and the upcoming therapeutic study based on the safety profile and positive biodistribution data observed thus far.

Monopar Therapeutics is dedicated to developing innovative treatments for cancer patients. Their pipeline includes MNPR-101-Zr, currently in Phase 1 for imaging advanced cancers, and MNPR-101, a radio-immuno-therapeutic (RIT) in late preclinical stages for treating advanced cancers. The company is also engaged in early development programs targeting solid tumors.

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