Monopar Reports Positive Early Human Data Validating MNPR-101-Zr Tumor Targeting

Monopar Therapeutics Inc., a clinical-stage radiopharmaceutical company listed on Nasdaq under the ticker MNPR, has reported encouraging early results from its ongoing MNPR-101-Zr Phase 1 imaging and dosimetry clinical trial. These findings confirm the ability of MNPR-101-Zr to specifically target tumors in humans.

MNPR-101, Monopar's innovative humanized monoclonal antibody, targets cancers that express the urokinase plasminogen activator receptor (uPAR). This receptor is prevalent in a variety of cancers, including triple-negative breast, colorectal, bladder, ovarian, gastric, and pancreatic cancers. In the initial phase of the trial, a total-body positron emission tomography (PET) scan was conducted 168 hours (7 days) after the administration of MNPR-101-Zr. This imaging radioisotope is zirconium-89 conjugated to MNPR-101. The first patient in the trial, diagnosed with a high uPAR-expressing cancer, exhibited promising results. The PET images showed that MNPR-101-Zr had a high specificity and uptake in metastatic tumors compared to normal tissue. The areas with higher uptake corresponded to the locations of metastatic tumors observed in previous conventional FDG PET imaging.

Andrew Cittadine, Monopar’s Chief Operating Officer, expressed satisfaction, stating that the results demonstrated a highly preferential uptake in the tumors, which was the desired outcome.

The trial also compared MNPR-101-Zr against FDG, the current standard for detecting metastatic tumors. Using the Siemens Biograph Vision Quadra™ PET/CT scanner, it was observed that MNPR-101-Zr had significant uptake at known disease sites, showing retention over extended periods. This outcome is promising for future therapeutic applications, according to Professor Rodney Hicks, the lead investigator of the Phase 1 imaging and dosimetry trial.

In addition to the ongoing imaging trial, Monopar has received clearance in Australia to commence a Phase 1 therapeutic trial for MNPR-101-Lu, scheduled to start in the fourth quarter of this year.

Monopar’s Chief Executive Officer, Chandler Robinson, revealed that the company is looking forward to presenting additional data at the upcoming European Association of Nuclear Medicine 2024 Annual Congress in Hamburg, Germany. Their abstract has been recognized as a 'Top-Rated Oral Presentation' within the Scientific Program, highlighting the significance of their research.

Monopar Therapeutics Inc. is dedicated to developing novel treatments for cancer patients. Their pipeline includes MNPR-101-Zr for imaging advanced cancers, MNPR-101-Lu in Phase 1 for therapeutic applications, MNPR-101-Ac225 in late preclinical stages, and other early-stage programs targeting solid cancers.

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