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Monopar Granted Clearance for First-in-Human Phase 1 Trial of MNPR-101-Zr, a Novel Radiopharmaceutical Targeting Advanced Cancers

Wednesday, February 21, 2024

Monopar Therapeutics Inc. (Nasdaq: MNPR) has announced the clearance from the Human Research Ethics Committee (HREC) in Australia to initiate a Phase 1 dosimetry trial of its novel radiopharmaceutical MNPR-101-Zr.

This Phase 1 trial aims to evaluate tumor uptake, organ distribution, and safety of MNPR-101-Zr using positron emission tomography (PET) imaging in patients with advanced cancers.

MNPR-101-Zr is a zirconium-89 labeled version of MNPR-101, Monopar’s proprietary monoclonal antibody targeting the urokinase plasminogen activator receptor (uPAR). Preclinical studies in models of triple-negative breast, colorectal, and pancreatic cancers have shown promising uptake of MNPR-101-Zr in uPAR-expressing tumors. These findings, combined with efficacy studies using actinium-225 (Ac-225) bound to MNPR-101 in preclinical tumor models, suggest the potential of MNPR-101 as a targeted radiopharmaceutical for various advanced cancers.

Monopar, stated, “This milestone marks our entry into human clinical trials with our uPAR targeting agent, following notable advancements in the radiopharmaceutical sector targeting PSMA and SSTR2 expressing cancers.”

Pending positive results in tumor uptake, biodistribution, and safety from this Phase 1 trial, which is expected to enroll approximately 12 patients soon, the company plans to assess the efficacy of a therapeutically radio-labeled version of MNPR-101 bound to isotopes like Ac-225.



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