Monopar Provides Update on MNPR-101-Zr Radiopharma Clinical Trial

Rhea-AI Summary

Monopar Therapeutics Inc. announced that Professor Rodney Hicks will lead the MNPR-101-Zr Phase 1 dosimetry clinical trial in advanced cancer patients using advanced PET/CT scanners. The trial aims to develop innovative treatments for pancreatic cancer and triple negative breast cancer.

Oncology Doctor

The involvement of Professor Rodney Hicks, a prominent figure in radiopharmaceutical medicine, as the lead investigator for the MNPR-101-Zr clinical trial, is a significant development for Monopar Therapeutics. Professor Hicks's expertise in translating radiopharmaceutical agents into clinical practice is crucial, given the complexities of developing and assessing novel cancer therapies. The use of the advanced Siemens Biograph Vision Quadra PET/CT scanner at MTIC enhances the potential for precise imaging and targeting of cancer cells, which is vital for the treatment of cancers with high unmet medical needs, such as pancreatic cancer and triple-negative breast cancer.

From an oncological perspective, the Phase 1 dosimetry trial is foundational for establishing the safety profile and optimal dosing of MNPR-101-Zr. The collaboration with MTIC could accelerate the clinical development process and potentially lead to more effective treatment options for patients. The preclinical data mentioned, while not detailed here, seems to suggest promising results that warrant further investigation in a clinical setting.

Medical Research Analyst

Monopar Therapeutics' announcement is a strategic step in the company's clinical development pathway. The appointment of Professor Hicks, coupled with the deployment of cutting-edge imaging technology, is likely to bolster investor confidence. The preclinical data's positive indication, as referenced, suggests that MNPR-101-Zr could be a transformative agent in the treatment of certain cancers.

Investors should note that the trial is at an early stage and while the involvement of a high-caliber investigator and institution is promising, the path to commercialization is long and fraught with regulatory and clinical hurdles. The focus on cancers with high unmet medical needs, however, could position Monopar favorably in terms of potential expedited review processes and market demand if the trials prove successful.

Market Research Analyst

The oncology market is highly competitive, with numerous companies vying for a share of the growing demand for cancer therapeutics. Monopar's decision to engage Professor Hicks and MTIC for their MNPR-101-Zr trial is a strategic move that may differentiate them from competitors. The use of the Siemens Biograph Vision Quadra PET/CT scanner underscores the company's commitment to leveraging advanced technologies for improved patient outcomes.

For stakeholders, the progression of MNPR-101-Zr into clinical trials is a critical milestone that could have a positive impact on Monopar's market valuation. However, it's important to remain cautious, as positive outcomes from Phase 1 trials do not guarantee success in subsequent phases or final approval. The trial's outcome will also be a key determinant in Monopar's ability to secure partnerships or additional funding for further development.

WILMETTE, Ill., Feb. 27, 2024 (GLOBE NEWSWIRE) -- Monopar Therapeutics Inc. (Nasdaq: MNPR), a clinical-stage biopharmaceutical company focused on developing innovative treatments for cancer patients, today announced that the internationally recognized radiopharmaceutical physician, Professor Rodney Hicks, will be the lead investigator for Monopar’s MNPR-101-Zr Phase 1 dosimetry clinical trial in advanced cancer patients. Professor Hicks will enroll patients at the Melbourne Theranostic Innovation Centre (MTIC) and will use one of the world's most sensitive clinical total-body PET/CT (positron emission tomography–computed tomography) scanners, the Siemens Biograph Vision Quadra, to image the targeting ability of MNPR-101-Zr in cancer patients.

“We are very excited to have Professor Hicks as the lead investigator for our MNPR-101-Zr clinical trial,” said Chandler Robinson, MD, Monopar’s Chief Executive Officer. “He is a true pioneer in the radiopharma space, having helped introduce radiopharma agents into the clinic which are now approved globally for neuroendocrine tumors and prostate cancer, and having installed the first PET/CT in Australia and one of the first in the world.”

Professor Rodney Hicks, MBBS(Hons), MD, FRACP, FICIS, FAAHMS is the Founder, Chief Medical Officer, and Board Chair of Precision Molecular Imaging & Theranostics Pty Ltd, the company that operates MTIC. He is the former Director of Cancer Imaging at Peter MacCallum Centre in Melbourne, one of Australia’s largest cancer research centers, and has published over 650 research articles, reviews, and commentaries. In 2023, Professor Hicks received the Saul Hertz Award from the Society of Nuclear Medicine and Molecular Imaging for his lifetime contribution to radionuclide therapy.

“The preclinical data that Monopar announced on this past Thursday encourages us to translate this class of agents into the clinical domain. MNPR-101-Zr is being developed for cancers with very high unmet medical need, such as pancreatic cancer and triple negative breast cancer,” said Professor Hicks. “I founded MTIC in part to help patients gain access to promising new radiopharmaceuticals, and the entire MTIC team is looking forward to activating the MNPR-101-Zr trial shortly and enrolling patients.”

Additional information about the MNPR-101-Zr Phase 1 dosimetry clinical trial for advanced cancer patients as well as the recently announced associated preclinical data can be found at the following links: MNPR-101-Zr Phase 1 and Preclinical Data.

About Monopar Therapeutics Inc. 

Monopar Therapeutics is a clinical-stage biopharmaceutical company focused on developing innovative treatments for cancer patients. Monopar's pipeline consists of Phase 1b-stage camsirubicin for the treatment of advanced soft tissue sarcoma; Phase 1-stage MNPR-101 for radiopharmaceutical use in advanced cancers; and an early-stage camsirubicin analog, MNPR-202. 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: that Professor Rodney Hicks will be the lead investigator on Monopar’s MNPR-101-Zr Phase 1 dosimetry clinical trial in advanced cancer patients; that Professor Hicks will be enrolling patients at the Melbourne Theranostic Innovation Centre (MTIC) and will utilize one of the world's most sensitive PET/CT; and that the MTIC team is looking forward to activating the MNPR-101-Zr trial shortly and enrolling patients. The forward-looking statements involve risks and uncertainties including, but not limited to: that future preclinical or clinical data will not be as promising as the data to date; not initiating and enrolling the Phase 1 clinical trial; that MNPR-101-Zr may cause unexpected serious adverse effects or fail to image or be effective against the cancer tumors in humans; the potential for the HREC to put the Phase 1 trial on clinical hold at any time; 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.  

CONTACT:  

Monopar Therapeutics Inc.
Investor Relations  
Kim R. Tsuchimoto  
Chief Financial Officer  
kimtsu@monopartx.com  

Follow Monopar on social media for updates: 

Twitter: @MonoparTx  LinkedIn: Monopar Therapeutics

Who will be the lead investigator for Monopar's MNPR-101-Zr Phase 1 dosimetry clinical trial?

Professor Rodney Hicks will be the lead investigator for Monopar's MNPR-101-Zr Phase 1 dosimetry clinical trial.

What type of scanners will be used in the clinical trial?

The Siemens Biograph Vision Quadra, one of the world's most sensitive clinical total-body PET/CT scanners, will be used in the clinical trial.

What is the focus of the clinical trial?

The clinical trial aims to develop innovative treatments for cancers with high unmet medical needs, such as pancreatic cancer and triple negative breast cancer.

What is Professor Rodney Hicks' background?

Professor Rodney Hicks is an internationally recognized radiopharmaceutical physician and the Founder, Chief Medical Officer, and Board Chair of Precision Molecular Imaging & Theranostics Pty Ltd.

What award did Professor Hicks receive in 2023?

Professor Hicks received the Saul Hertz Award from the Society of Nuclear Medicine and Molecular Imaging in 2023 for his lifetime contribution to radionuclide therapy.