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Monopar Announces First Patient Enrolled in First-in-Human Phase 1 Trial for Its Novel Radiopharmaceutical MNPR-101-Zr

Key Takeaway: Monopar Therapeutics has announced the enrollment of the first patient in its Phase 1 clinical trial for MNPR-101-Zr, a novel radiopharmaceutical targeting advanced cancers. The trial, led by Professor Rodney Hicks, aims to evaluate the safety and dosimetry of this innovative imaging agent. MNPR-101-Zr combines antibody targeting with zirconium-89 radioisotope to improve cancer imaging. While early preclinical results are encouraging, there are inherent risks associated with the trial and potential adverse effects.
Price reaction · baseline $3.6895 (2024-07-08 close) · hit after-hours · clean, no other MNPR news in the window
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Market Sentiment Analysis

POSITIVE FACTORS

  • Enrollment of the first patient in a groundbreaking Phase 1 trial.
  • Potential of MNPR-101-Zr targeting uPAR for treating aggressive cancers.
  • Support from recognized experts in nuclear medicine overseeing the trial.

CONCERNS & RISKS

  • The study's results may not meet expectations.
  • Potential for unexpected serious adverse effects in humans.
  • Funding limitations could impact the trial's progress.

BiopharmaWatch Analysis

From our catalyst data and publicly available data · not financial advice
Best trade, last catalyst
+140%
120-day peak, hindsight
Typical move
5.5%
average across 4 past catalysts
Cash runway
~97 mo
Minimal dilution risk
Lead asset
MNPR-101-PCTA-177Lu
Phase 1 · Solid Tumor, Adult

Full Press Release Details

WILMETTE, Ill., July 09, 2024 (GLOBE NEWSWIRE) -- Monopar Therapeutics Inc. (Nasdaq: MNPR), a clinical-stage radiopharma company focused on developing innovative treatments for cancer patients, today announced the enrollment of the first patient in its first-in-human Phase 1 dosimetry and imaging clinical trial of MNPR-101-Zr. This novel radiopharmaceutical imaging agent combines MNPR-101, Monopar’s antibody that selectively targets the urokinase plasminogen activator receptor (uPAR), with the radioisotope zirconium-89.
Monopar’s Phase 1 clinical trial, led by internationally recognized nuclear medicine physician Professor Rodney Hicks at the Melbourne Theranostic Innovation Centre, aims to assess the safety and dosimetry of MNPR-101-Zr in up to 12 patients with advanced cancers. This is the first human study to evaluate a radiolabeled monoclonal antibody targeting uPAR.
“uPAR is a well-credentialed cancer target found in some of the most aggressive, deadly cancers, including pancreatic, triple negative breast, and colorectal cancers. We are very much looking forward to seeing the biodistribution and dosimetry data from this study,” said Chandler Robinson, MD, Monopar’s Chief Executive Officer.
“We are pleased to enroll our inaugural patient. Encouraging preclinical results in several challenging cancers underscore the potential of uPAR as a promising target to battle some of the most lethal cancers,” added Andrew Cittadine, Monopar’s Chief Operating Officer.
Further information about this clinical trial is available at www.ClinicalTrials.gov under study identifier NCT06337084.
About Monopar Therapeutics Inc.
Monopar Therapeutics is a clinical-stage radiopharmaceutical company focused on developing innovative treatments for cancer patients, including Phase 1-stage MNPR-101-Zr for imaging advanced cancers and late preclinical-stage MNPR-101 radio-immuno-therapeutic (RIT) for the treatment of advanced cancers, as well as early development programs against solid cancers. For more information, visit: www.monopartx.com.
Forward-Looking Statements
Statements contained in this press release regarding matters 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,” “target” 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 statements concerning: The Company’s Phase 1 trial aims to assess the safety and dosimetry of MNPR-101-Zr in up to 12 patients with advanced cancers; Monopar is very much looking forward to seeing the biodistribution and dosimetry data from this Phase-1 trial; and that encouraging preclinical results in several challenging cancers underscore the potential of uPAR as a promising target to battle some of the most lethal cancers. The forward-looking statements involve risks and uncertainties including, but not limited to: the enrolled patient may not receive the scheduled dose of MNPR-101-Zr; the Phase 1 imaging and dosimetry clinical trial in advanced cancer patients with MNPR-101-Zr may not yield satisfactory results, if at all; that future preclinical or clinical data will not be as promising as the data to date; that MNPR-101-Zr may cause unexpected serious adverse effects in humans; that Monopar may expend available funds sooner than anticipated or require additional funding due to change in circumstances or unanticipated events; and the significant general risks and uncertainties surrounding 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. Risks are described more fully 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 on which they were made. Monopar undertakes no obligation to update such statements to reflect events that occur or circumstances that exist after the date on which they were made. Any forward-looking statements contained in this press release represent Monopar’s views only as of the date hereof and should not be relied upon as representing its views as of any subsequent date.
Monopar Therapeutics Inc.
Karthik Radhakrishnan
Chief Financial Officer
Follow Monopar on social media for updates:
Twitter: @MonoparTx  LinkedIn: Monopar Therapeutics

Frequently Asked Questions

What is the focus of Monopar Therapeutics?

Monopar Therapeutics focuses on developing innovative cancer treatments.

What is MNPR-101-Zr?

MNPR-101-Zr is a radiopharmaceutical imaging agent targeting uPAR.

How many patients will join the Phase 1 clinical trial?

The Phase 1 clinical trial will enroll up to 12 patients.

What type of cancers does uPAR target?

uPAR targets aggressive cancers like pancreatic and triple negative breast cancer.

Where can I find more information about the clinical trial?

More information is available at ClinicalTrials.gov under identifier NCT06337084.

Last updated: Jul 9, 2024