Monopar and NorthStar Amend & Extend Collaboration
Monopar Therapeutics (Nasdaq: MNPR) and NorthStar Medical Radioisotopes have expanded their collaboration to include a long-term supply agreement for actinium-225 (Ac-225). This strategic move aligns intellectual property rights and leverages NorthStar's expertise in Ac-225 production with Monopar's promising preclinical results using Ac-225 in its MNPR-101 radiopharma program. Monopar has acquired full ownership of MNPR-101's radiopharmaceutical applications, while both companies will share a patent application for a new linker technology. This collaboration aims to support Monopar's current and future cancer therapy developments.
- Long-term supply agreement ensures a stable source of Ac-225 for Monopar.
- Monopar gains full ownership of MNPR-101 radiopharmaceutical platform.
- Shared patent for new linker technology with superior binding properties.
- NorthStar's expertise in Ac-225 production supports Monopar's development.
- Potential to enhance Monopar's cancer treatment pipeline.
- No immediate financial gains or revenues reported from the collaboration.
- Long-term collaboration may delay short-term financial performance.
- Potential dependency on NorthStar for Ac-225 supply.
Insights
The expanded collaboration between Monopar Therapeutics and NorthStar Medical Radioisotopes signifies a substantial development in the realm of radiopharmaceuticals, particularly concerning the therapeutic use of actinium-225 (Ac-225). Monopar's preclinical results with its MNPR-101 platform, which targets aggressive cancers, coupled with NorthStar's investment in Ac-225 manufacturing, present a promising synergy.
Actinium-225 is a potent radioisotope used in targeted alpha therapy (TAT), offering highly lethal radiation to cancer cells with minimal impact on surrounding healthy tissue. The long-term supply agreement guarantees Monopar access to a consistent source of Ac-225, potentially accelerating the development timeline for MNPR-101. This is important as consistent supply chains are imperative for clinical trials and eventual FDA approval.
The amendment also aligns intellectual property rights, which is significant. Full ownership and title to the MNPR-101 platform allow Monopar greater control over its development and commercialization pathways, potentially making the company an attractive candidate for partnerships or acquisitions.
From a financial perspective, this collaboration extension might solidify Monopar's position in the market, providing a stable foundation for future growth. The long-term supply agreement with NorthStar ensures Monopar will have reliable access to Ac-225, which is critical for maintaining development momentum and potentially expediting the time to market for their MNPR-101 platform.
This agreement could also positively impact Monopar's valuation. Investors often view secured supply chains and clear intellectual property rights favorably, as these reduce future uncertainties. Clarity in economic terms and intellectual property ownership can make Monopar more financially attractive and might lead to increased investor confidence, potentially boosting share prices in the short term.
That said, retail investors should remain cautious of the inherent risks in clinical-stage companies, including the high costs and potential failures of clinical trials. While this collaboration mitigates some risks by securing a supply chain and solidifying intellectual property rights, the success of Monopar's MNPR-101 still largely hinges on forthcoming clinical trial results and regulatory approvals.
Highlights:
- Builds on Companies’ respective core strengths
- Aligns intellectual property rights
- Establishes a long-term supply agreement under which NorthStar provides actinium-225 for Monopar’s development and potential future commercial programs
WILMETTE, Ill. and Beloit, Wis., June 11, 2024 (GLOBE NEWSWIRE) -- Monopar Therapeutics Inc. (Nasdaq: MNPR), a clinical-stage radiopharma company, and NorthStar Medical Radioisotopes, LLC, a global innovator in development and commercial production of medical radioisotopes, today announced an amendment and expansion to their existing collaboration. Under terms of the revised collaboration, the Companies entered into a long-term, non-exclusive master supply agreement for NorthStar to provide Monopar with the powerful therapeutic radioisotope actinium-225 (Ac-225). The amendment builds on NorthStar’s significant investment in Ac-225 manufacturing and Monopar’s promising preclinical therapeutic results with Ac-225 in its lead MNPR-101 radiopharma program.
The amendment also clarifies certain economic terms and those related to jointly developed intellectual property rights for Monopar’s MNPR-101 for radiopharmaceutical use. Monopar has acquired those rights from NorthStar, together with certain broad, jointly developed intellectual property pertaining to MNPR-101, giving Monopar full ownership and title to its lead MNPR-101 radiopharmaceutical platform. Both companies will share ownership of the filed patent application on the use of PCTA as a linker with Ac-225, which has shown superior binding and yield with Ac-225 over the current industry-leading linker, DOTA.
“We are excited about the evolution of our collaboration, the promising potential of the MNPR-101 radiopharma platform, and the long-term access to a high-quality source of Ac-225 that can support our current development programs and potential future commercial products,” said Chandler Robinson, MD, Monopar’s Chief Executive Officer.
“Using our proprietary electron accelerator technology, NorthStar is poised to be the first commercial-scale producer of non-carrier added (n.c.a.) Ac-225. We’re delighted to continue and extend our collaboration with Monopar and support development of its exciting MNPR-101 radiopharma platform focused on therapeutic agents to treat aggressive cancers,” said Frank Scholz, PhD, NorthStar’s Chief Executive Officer.
About Monopar Therapeutics Inc. (Monopar)
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. For more information, visit: www.monopartx.com.
About NorthStar Medical Radioisotopes, LLC (NorthStar)
NorthStar Medical Radioisotopes is a commercial-stage radiopharmaceutical company at the forefront of advancing patient care by utilizing novel technologies to produce commercial-scale radioisotopes that, once attached to a molecule, have the ability to detect and treat cancer and other serious diseases. NorthStar’s expanding industry-leading position in the emerging field of radiopharmaceutical therapy is supported by its unique capabilities in the sophisticated production of radioisotopes, proven management team, and state-of-the-art, environmentally preferable technologies. NorthStar routinely produces copper-67 (Cu-67) and is poised to be the first commercial-scale producer of non-carrier-added (n.c.a.) actinium-225 (Ac-225). The Company’s Radiopharmaceutical Contract Development and Manufacturing Organization (CDMO) services unit provides customized service offerings and specialized radiopharmaceutical expertise to help biopharmaceutical companies rapidly advance their development and commercial programs. For more information about NorthStar’s comprehensive portfolio and patient-focused services, visit: www.northstarnm.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: that NorthStar will provide actinium-225 for Monopar’s development and potential future commercial programs; the promising potential of Monopar’s MNPR-101 radiopharma platform, and the long-term access to a high-quality source of Ac-225 that can support Monopar’s current development programs and potential future commercial products; that NorthStar is poised to be the first commercial-scale producer of non-carrier added (n.c.a.) Ac-225; and that NorthStar will continue to support development of Monopar’s exciting MNPR-101 radiopharma platform focused on therapeutic agents to treat aggressive cancers. The forward-looking statements involve risks and uncertainties including, but not limited to: that Monopar’s and shared intellectual property may not result in allowed patents; that if allowed, the patents may be too narrow in scope to provide protection needed to successfully develop the radiopharma program; that NorthStar may not be able to supply Ac-225 at quantities needed, if at all; that NorthStar may not be the first commercial-scale producer of n.c.a. Ac-225; that Monopar may expend available funds sooner than anticipated or require additional funding due to change in circumstances or unanticipated events; that future preclinical or clinical data will not be as promising as the data to date; not successfully enrolling the MNPR-101-Zr Phase 1 clinical trial if at all; that MNPR-101-Zr and/or MNPR-101 conjugated to a therapeutic radioisotope may cause unexpected serious adverse effects or fail to image or be effective against the cancer tumors in humans; 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 and/or NorthStar’s views only as of the date hereof and should not be relied upon as representing its views as of any subsequent date.
CONTACTS:
For Monopar Therapeutics Inc.
Investor Relations
Kim R. Tsuchimoto
Chief Financial Officer
kimtsu@monopartx.com
Follow Monopar on social media for updates:
X (formerly Twitter): @MonoparTx LinkedIn: Monopar Therapeutics
For NorthStar Medical Radioisotopes, LLC :
Investor Relations:
Paul Estrem
Executive Vice President and Chief Financial Officer
pestrem@northstarnm.com
Media/Corporate:
Alison Hess
Vice President, Chief of Staff
ahess@northstarnm.com
FAQ
What is the significance of Monopar and NorthStar's collaboration for MNPR?
How does the Monopar and NorthStar agreement affect MNPR-101?
What are the benefits of the new linker technology in the Monopar and NorthStar patent?
What does the long-term supply agreement mean for Monopar's future developments?
How does NorthStar's Ac-225 production expertise benefit Monopar?
