Monopar receives approval to conduct Phase 1 therapy trial of a novel radiopharmaceutical in advanced cancer

WILMETTE, Ill., Aug. 21, 2024 (GLOBE NEWSWIRE) — Monopar Therapeutics Inc. (Nasdaq: MNPR), a clinical-stage radiopharmaceutical company focused on developing innovative treatments for patients with cancer, today announced that it has received approval from the Human Research Ethics Committee (HREC) in Australia to initiate a Phase 1 therapeutic trial of its novel radiopharmaceutical MNPR-101-Lu.

MNPR-101-Lu combines the therapeutic radioisotope lutetium-177 (Lu-177) with Monopar's proprietary humanized monoclonal antibody MNPR-101, which is highly selective against the urokinase plasminogen activator receptor (uPAR). The Phase 1 clinical trial of MNPR-101-Lu will enroll patients with advanced solid cancers. It is a therapeutic follow-on study to the currently ongoing MNPR-101-Zr imaging and dosimetry clinical trial.

The results of preclinical studies of MNPR-101-Lu are promising. For example, in a 90-day efficacy study in a human pancreatic cancer xenograft mouse model (Figure 1, bottom), MNPR-101-Lu demonstrated durable antitumor effects after a single injection, achieving complete tumor elimination that was sustained for the duration of the study.

MNPR-101-Lu imaging data in a human pancreatic cancer xenograft mouse model presented in March (link, Figure 2 below) provide additional insight into the potent therapeutic effect observed following a single injection of MNPR-101-Lu. The imaging data demonstrate the high specificity and durable uptake of MNPR-101-Lu in the tumor compared to normal tissue.

“We are pleased with HREC approval and encouraged by the potential of MNPR-101-Lu to provide meaningful clinical benefit to patients with uPAR-positive tumors. Some of the most aggressive and deadly cancers express uPAR, including triple-negative breast cancer and pancreatic cancer,” said Chandler Robinson, MD, CEO of Monopar. “We look forward to starting the trial as soon as possible.”

About Monopar Therapeutics Inc.

Monopar Therapeutics is a clinical-stage radiopharmaceutical company focused on developing innovative treatments for cancer patients, including MNPR-101-Zr in Phase 1 for imaging advanced cancers and MNPR-101-Lu and MNPR-101-Ac225 in late preclinical stages for the treatment of advanced cancers, as well as early development programs in solid cancers. For more information, visit: www.monopartx.com.

Forward-looking statements

Statements in this press release that are not historical facts are “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995. The words “may,” “will,” “could,” “would,” “should,” “expect,” “plan,” “anticipate,” “intend,” “believe,” “estimate,” “predict,” “project,” “potential,” “continue,” “seek” and similar expressions are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words. Examples of these forward-looking statements include: that the Phase 1 clinical trial of MNPR-101-Lu will enroll patients with advanced solid cancers and will be a therapeutic continuation of the currently ongoing imaging and dosimetry clinical trial of MNPR-101-Zr; that results from the preclinical studies of MNPR-101-Lu are promising; that these data support the potential of MNPR-101-Lu to provide meaningful clinical benefit to patients with uPAR-positive tumors; and that Monopar looks forward to initiating the trial as soon as possible. The forward-looking statements involve risks and uncertainties, including, but not limited to: that Monopar may not initiate its therapeutic trial of MNPR-101-Lu even after it receives regulatory approval; that the Phase 1 imaging and dosimetry clinical trial in patients with advanced cancer with MNPR-101-Zr may not produce satisfactory results, if any; that future preclinical or clinical data may not be as promising as data to date; that MNPR-101-Zr and/or MNPR-101-Lu may cause unexpected serious side effects or may not detect or effectively target cancer tumors in humans; and the substantial general risks and uncertainties associated with the research, development, regulatory approval and commercialization of imaging agents and therapeutics. Actual results may differ materially from those expressed or implied by such forward-looking statements. The risks are more fully described in Monopar's filings with the Securities and Exchange Commission. All forward-looking statements contained in this press release speak only as of the date hereof. Monopar undertakes no obligation to update such statements to reflect events or circumstances that occur after the date hereof. All forward-looking statements contained in this press release represent the views of Monopar only as of the date hereof and should not be relied upon as reflecting views as of any subsequent date.

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CONTACT:

Monopar Therapeutics Inc.
Investor information
Karthik Radhakrishnan
Chief Financial Officer
[email protected]

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