Monopar Gets Green Light for Phase 1 Trial of MNPR-101-Zr in Advanced Cancer Patients

Monopar Therapeutics Inc., a biopharmaceutical firm listed on Nasdaq as MNPR, has been given the green light by the Human Research Ethics Committee (HREC) in Australia to initiate a Phase 1 dosimetry study for its innovative radiopharmaceutical, MNPR-101-Zr. This marks a pivotal step for the company, which is dedicated to creating advanced cancer treatments.
The clinical trial, designed for patients with advanced-stage cancers, will employ positron emission tomography (PET) to evaluate the uptake of the drug in tumors, its distribution in normal organs, and its overall safety. MNPR-101-Zr is distinguished by its use of zirconium-89, an imaging radioisotope, and is a derivative of Monopar’s proprietary monoclonal antibody, MNPR-101. This antibody is specifically targeted against the urokinase plasminogen activator receptor (uPAR), which is overexpressed in various cancer types.
Preclinical studies using PET imaging on models of triple-negative breast, colorectal, and pancreatic cancers have demonstrated MNPR-101-Zr's high uptake in uPAR-expressing tumors. These findings, along with the promising results from preclinical efficacy studies using actinium-225 (Ac-225), a potent alpha-emitting therapeutic radioisotope, have set the stage for the development of MNPR-101 as a targeted radiopharmaceutical for a range of advanced cancers.
Monopar’s CEO, Dr. Chandler Robinson, expressed optimism about the potential of MNPR-101, citing recent advancements in radiopharmaceutical treatments and the company's well-prepared position in the field. The Phase 1 trial is expected to include approximately 12 patients and is set to begin shortly. If the initial results are positive, the company plans to assess the therapeutic effectiveness of MNPR-101 when radio-labeled with an isotope like Ac-225.
Monopar Therapeutics is a clinical-stage company with a pipeline that includes camsirubicin for soft tissue sarcoma, MNPR-101 for radiopharmaceutical applications, and the early-stage camsirubicin analog, MNPR-202.

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