Monopar Cleared for Phase 1 Trial of New Cancer Radiopharmaceutical

WILMETTE, Ill., Aug. 21, 2024 — Monopar Therapeutics Inc. (Nasdaq: MNPR), a clinical-stage company dedicated to developing novel cancer treatments, has announced receiving clearance from the Human Research Ethics Committee (HREC) in Australia to begin a Phase 1 therapeutic trial of its innovative radiopharmaceutical, MNPR-101-Lu.

MNPR-101-Lu integrates lutetium-177 (Lu-177), a therapeutic radioisotope, with Monopar’s unique humanized monoclonal antibody MNPR-101. This antibody is highly selective for the urokinase plasminogen activator receptor (uPAR), a target implicated in numerous aggressive cancers. The Phase 1 trial will involve patients with advanced solid tumors and serves as a therapeutic extension to the ongoing MNPR-101-Zr imaging and dosimetry trial.

Preclinical data for MNPR-101-Lu has shown promising outcomes. For instance, in a 90-day study involving a human pancreatic cancer xenograft mouse model, a single injection of MNPR-101-Lu resulted in a durable antitumor effect, completely eliminating tumors for the study's duration.

Imaging data from a human pancreatic cancer xenograft mouse model published in March further supports the potential of MNPR-101-Lu. The imaging results highlighted the specific and sustained uptake of MNPR-101-Lu in tumors compared to normal tissues, underscoring its potential therapeutic efficacy after a single dose.

Chandler Robinson, MD, CEO of Monopar, expressed optimism about the HREC clearance. “We are thrilled about this clearance and the potential of MNPR-101-Lu to offer significant clinical benefits to patients with uPAR-positive tumors. Many of the deadliest cancers, including triple negative breast cancer and pancreatic cancer, express uPAR,” he stated. “We are eager to initiate the trial as soon as possible.”

Monopar Therapeutics Inc. is a clinical-stage radiopharmaceutical company that focuses on developing cutting-edge treatments for cancer patients. Their pipeline includes MNPR-101-Zr for imaging advanced cancers, MNPR-101-Lu, and MNPR-101-Ac225 for treating advanced cancers, alongside other early-stage programs targeting solid tumors.