Monopar Begins Trial of New uPAR-Targeted Cancer Therapy

Monopar Therapeutics Inc. (Nasdaq: MNPR), a company in the clinical stages of developing radiopharmaceutical treatments for cancer, announced the initiation of its Phase 1a clinical trial for the novel therapeutic radiopharmaceutical MNPR-101-Lu. This compound, which is MNPR-101 linked to lutetium-177, is aimed at treating patients with advanced cancers. The trial is now active and recruiting participants.

The Phase 1a trial is designed as an open-label, dose-escalation study targeting patients with solid tumors. The Melbourne Theranostic Innovation Centre (MTIC) in Australia is the first site activated for this study. To identify patients who could benefit most from MNPR-101-Lu, the trial will include only those who are also participating in the ongoing MNPR-101-Zr Phase 1 imaging and dosimetry clinical trial.

MNPR-101, Monopar’s proprietary antibody, targets the urokinase plasminogen activator receptor (uPAR), a receptor found in various tumor types such as pancreatic, breast, colorectal, ovarian, and bladder cancers. Monopar's strategy involves selectively targeting uPAR to deliver radiopharmaceutical therapy that can kill cancer cells while minimizing harm to healthy tissue. Both clinical and preclinical data have demonstrated specific and sustained tumor uptake of MNPR-101-Zr, which is MNPR-101 linked to zirconium-89.

Chandler Robinson, MD, Monopar’s Chief Executive Officer, expressed optimism about the trial. “We are very encouraged by the recently released human clinical data and preclinical efficacy results, and are thrilled to be launching this therapeutic trial months ahead of our originally planned schedule,” Robinson said.

Andrew Cittadine, Monopar’s Chief Operating Officer, added, “We believe this may be the world’s first uPAR-targeted therapeutic radiopharma clinical trial. Our goal is to illuminate the tumors with MNPR-101-Zr and then treat them with MNPR-101-Lu.”

Additional details about the MNPR-101-Lu trial can be found at ClinicalTrials.gov under the study identifier NCT06617169. Information regarding the ongoing MNPR-101-Zr Phase 1 imaging and dosimetry clinical trial is also available at ClinicalTrials.gov under the study identifier NCT06337084.

Monopar Therapeutics Inc. is a clinical-stage radiopharmaceutical company dedicated to developing novel treatments for cancer patients. Their pipeline includes MNPR-101-Zr, which is in Phase 1 for imaging advanced cancers, MNPR-101-Lu in Phase 1a for treating advanced cancers, and MNPR-101-Ac225 in late preclinical stages. They are also working on early development-stage radiopharma programs targeting solid tumors.

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