Monopar Gets Approval to Start Phase 1 Trial of New Radiopharmaceutical for Advanced Cancers

Monopar Therapeutics Inc. (Nasdaq: MNPR), a clinical-stage company specializing in radiopharmaceuticals for cancer treatment, revealed that it has obtained Human Research Ethics Committee (HREC) approval in Australia to initiate a Phase 1 clinical trial for its innovative radiopharmaceutical MNPR-101-Lu.

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MNPR-101-Lu fuses the therapeutic radioisotope lutetium-177 (Lu-177) with Monopar’s proprietary humanized monoclonal antibody  MNPR-101, which specifically targets the urokinase plasminogen activator receptor (uPAR). The Phase 1 clinical trial for MNPR-101-Lu aims to enroll patients with advanced solid tumors and will act as a therapeutic extension to the ongoing MNPR-101-Zr imaging and dosimetry trial.

Preclinical studies of MNPR-101-Lu show promising results. In a 90-day study evaluating efficacy in a human pancreatic cancer xenograft mouse model, a single injection of MNPR-101-Lu induced sustained antitumor activities, completely eliminating tumors for the study's entire duration.

Additional insights into the therapeutic efficacy were provided by imaging data from a human pancreatic cancer xenograft mouse model presented in March (see link and Figure 2 below). The imaging results indicate high specificity and sustained uptake of MNPR-101-Lu within the tumor as compared to normal tissues.

“We are thrilled with the HREC clearance and optimistic about the potential of MNPR-101-Lu to offer substantial clinical benefits for patients with uPAR-positive tumors,” commented Chandler Robinson, MD, Monopar’s Chief Executive Officer. “Several highly aggressive and lethal cancers, such as triple-negative breast cancer and pancreatic cancer, express uPAR. We are eager to initiate the trial as swiftly as possible.”

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According to the data provided by the Synapse Database, As of August 26, 2024, there are 18 investigational drugs for the uPAR target, including 37 indications, 16 R&D institutions involved, with related clinical trials reaching 15, and as many as 14345 patents.

MNPR-101 is a monoclonal antibody drug developed by Monopar Therapeutics, Inc., with its highest phase being pending. The drug targets uPAR and is intended for use in the therapeutic areas of neoplasms. Monoclonal antibodies are a type of biopharmaceutical drug that are designed to target specific proteins in the body. In the case of MNPR-101, the target is uPAR, which is a receptor that is often overexpressed in cancer cells. By targeting uPAR, MNPR-101 aims to inhibit the growth and spread of neoplastic cells, potentially offering a new treatment option for cancer patients.