Monopar Receives Clearance to Proceed with First-in-Human Phase 1 Trial of Novel Radiopharmaceutical MNPR-101-Zr in Advanced Cancers
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Insights
The clearance for a Phase 1 dosimetry trial of MNPR-101-Zr in Australia represents a pivotal step for Monopar Therapeutics in its clinical development pathway. The trial's focus on evaluating tumor uptake, normal organ biodistribution and safety parameters through PET imaging is a critical component of early-stage radiopharmaceutical development. PET imaging is a sophisticated technique that allows for the non-invasive visualization of cellular function and is widely used in oncology to assess the distribution and localization of radiotracers like MNPR-101-Zr.
The urokinase plasminogen activator receptor (uPAR) is a significant biomarker in cancer biology, often associated with tumor invasion and metastasis. Monopar's strategic focus on uPAR with its proprietary antibody MNPR-101 could address a specific niche in targeted cancer therapy, particularly given the high and selective uptake in uPAR-expressing tumors observed in preclinical models. The use of zirconium-89, a radioisotope with a half-life suitable for PET imaging, further underscores the potential for MNPR-101-Zr to provide meaningful insights into tumor biology and therapy response.
However, it is important to note that Phase 1 trials are primarily designed to assess safety and dosimetry, not efficacy. As such, while the trial is a necessary step, its outcomes will not immediately translate into a marketable product but rather inform subsequent development stages. The long-term impact on Monopar's business will depend on the success of this and subsequent trials, including eventual Phase 2 and 3 studies that will more directly assess therapeutic efficacy.
The initiation of a Phase 1 trial in the field of radiopharmaceuticals is particularly noteworthy due to the recent successes in the sector, such as therapies targeting PSMA in prostate cancer and SSTR2 in neuroendocrine tumors. These successes have bolstered the credibility of targeted radiopharmaceuticals as a promising treatment modality. Monopar's MNPR-101-Zr could potentially join the ranks of these innovative treatments if clinical data align with preclinical findings.
From an oncological perspective, the ability to provide targeted treatment to advanced cancer patients, who often have limited options, is of great clinical importance. The utilization of actinium-225 (Ac-225) in future studies as a therapeutic radioisotope is significant due to its potent alpha-emission, which can induce substantial DNA damage within cancer cells. The dual utility of MNPR-101 as both an imaging and therapeutic agent could offer a theranostic approach, wherein the same molecule is used for diagnosis and therapy, streamlining the treatment process for patients with advanced cancers.
Nevertheless, the journey from Phase 1 to a clinically approved treatment is long and fraught with challenges. The small sample size anticipated for the trial (around 12 patients) is typical for Phase 1 studies but limits the generalizability of the results. Moreover, the safety profile and efficacy in humans will need to be robust to justify further investment and development.
The announcement of HREC clearance for Monopar Therapeutics' Phase 1 trial is a development of considerable interest to investors, as it signals progression in the company's pipeline and the potential for future revenue streams. The field of radiopharmaceuticals has been gaining traction, with several high-profile approvals and acquisitions underscoring the market's growth potential. Monopar's entry into this space with a novel agent targeting uPAR could position the company favorably if clinical outcomes are positive.
Investors should, however, maintain a cautious approach. The nature of biopharmaceutical investing involves considerable risk, especially at early clinical stages. The outcomes of the Phase 1 trial will be instrumental in determining Monopar's near-term financial health and its ability to attract further investment or partnership opportunities. Positive trial results could lead to an uptick in investor confidence and potentially an increase in stock value, while any setbacks could have the opposite effect.
Moreover, the biopharmaceutical sector is highly competitive and Monopar's success hinges not only on clinical outcomes but also on navigating regulatory pathways, securing intellectual property rights and scaling up manufacturing capabilities. The long-term financial implications will also depend on the company's strategy for commercialization, including whether they pursue collaborations with larger pharmaceutical companies or aim to bring the product to market independently.
WILMETTE, Ill., Feb. 20, 2024 (GLOBE NEWSWIRE) -- Monopar Therapeutics Inc. (Nasdaq: MNPR), a clinical-stage biopharmaceutical company focused on developing innovative treatments for cancer patients, today announced it has received Human Research Ethics Committee (HREC) clearance in Australia to commence a Phase 1 dosimetry trial of its novel radiopharmaceutical MNPR-101-Zr.
The MNPR-101-Zr Phase 1 dosimetry clinical trial will enroll patients with advanced cancers and will utilize positron emission tomography (PET) imaging to assess tumor uptake, normal organ biodistribution, and safety.
MNPR-101-Zr is a zirconium-89 (imaging radioisotope) labeled version of MNPR-101, Monopar’s proprietary first-in-class humanized monoclonal antibody that is highly selective against the urokinase plasminogen activator receptor (uPAR). PET imaging studies in preclinical xenograft models of triple-negative breast, colorectal, and pancreatic cancers displayed high and selective uptake of MNPR-101-Zr in these uPAR-expressing tumors. The imaging results, along with corresponding in vivo efficacy studies with actinium-225 (Ac-225, a powerful alpha-emitting therapeutic radioisotope) bound to MNPR-101 in preclinical xenograft tumor models, support the development MNPR-101 as a targeted radiopharmaceutical for multiple advanced cancer indications.
“This is a significant milestone for Monopar,” said Chandler Robinson, MD, Monopar’s Chief Executive Officer. “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. There has been quite impressive clinical data generated in the radiopharma sector of late, such as against PSMA and SSTR2 expressing cancers, and we believe this to be just the beginning.”
If the tumor uptake, biodistribution, and safety look encouraging in this Phase 1 clinical trial, which is anticipated to enroll around 12 patients and to initiate in the near future, the plan is to evaluate the efficacy in humans of a therapeutically radio-labeled version of MNPR-101 bound to an isotope such as Ac-225.
About Monopar Therapeutics Inc.
Monopar Therapeutics is a clinical-stage biopharmaceutical company primarily 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 advance 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 MNPR-101-Zr Phase 1 dosimetry clinical trial will enroll patients with advanced cancers and will utilize positron emission tomography (PET) imaging to assess tumor uptake, normal organ biodistribution, and safety; that the Phase 1 clinical trial is anticipated to enroll around 12 patients in the near future; and that the plan is to evaluate the efficacy in humans of a therapeutically radio-labeled version of MNPR-101 bound to an isotope such as Ac-225. The forward-looking statements involve risks and uncertainties including, but not limited to: not initiating and enrolling the Phase 1 clinical trial in 2024, if at all; that MNPR-101-Zr may cause unexpected serious adverse effects or fails to image 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
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FAQ
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What is MNPR-101-Zr and how is it related to MNPR-101?
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Who is Chandler Robinson and what is his role at Monopar Therapeutics Inc. (MNPR)?
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