Monopar Therapeutics (NASDAQ: MNPR) stock skyrocketed on news of HREC clearance in Australia for the Phase 1 dosimetry trial of MNPR-101-Zr.
Monopar Therapeutics (MNPR) received clearance from the Human Research Ethics Committee (HREC) in Australia that paves the way for Monopar to initiate its Phase 1 dosimetry trial of MNPR-101-Zr, marking a significant milestone for the company.
The trial will enroll 12 subjects with advanced cancers and focuses on utilizing positron emission tomography (PET) imaging to evaluate tumor uptake, normal organ biodistribution, and safety parameters.
MNPR-101-Zr represents a zirconium-89-labeled variant of MNPR-101, an innovative humanized monoclonal antibody developed by Monopar. MNPR-101 targets the urokinase plasminogen activator receptor (uPAR) with exceptional specificity, making it a promising candidate for imaging purposes as an imaging radioisotope.
PET imaging studies have showcased selective uptake of MNPR-101-Zr in uPAR-expressing tumors in preclinical xenograft models of triple-negative breast, colorectal, and pancreatic cancers.
The imaging findings, coupled with in vivo effectiveness trials utilizing actinium-225 (Ac-225, a potent alpha-emitting therapeutic radioisotope) attached to MNPR-101 in preclinical xenograft tumor models, bolster the development of MNPR-101 as a targeted radiopharmaceutical for various advanced cancer conditions.
Chandler Robinson, MD, Monopar’s Chief Executive Officer, said,
“This is a significant milestone for Monopar.”
He added,
“Following more than 18 months of extensive preclinical development, we believe we are well-positioned in this space. This is our first human clinical trial using our uPAR targeting agent.”
Monopar Therapeutics will evaluate the efficacy of a therapeutically radio-labeled version of MNPR-101 bound to an isotope such as Ac-225 in humans, contingent upon positive outcomes in tumor uptake, biodistribution, and safety observed in this Phase 1 trial.
Monopar Therapeutics (NASDAQ: MNPR) Stock Price Action
MNPR stock soared 95.27% to close at $0.67 on Tuesday. The traders had exchanged hands with 100,113,621 (100.11 million) shares compared to the average daily trading volume of 161.32K.
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