MNPR Monopar Therapeutics Inc.
Drug Pipeline
| Drug | Stage | Notes |
|---|---|---|
|
Camsirubicin
Soft tissue sarcoma
|
Phase 2
Phase 2
|
Phase 2 trial to commence 2H 2021.
|
|
Validive (VOICE)
Oral mucositis
|
Phase 2/3
Phase 2/3
|
Phase 2b/3 initiation of dosing announced February 16, 2021.
|
Latest News
-
View Full Article Hide Full Article
First Patient Dosed in Validive® Phase 2b/3 VOICE Clinical Trial
Camsirubicin Run-in Clinical Trial Now Planned to Start in 2H 2021
Potential Utility Reported for MNPR-101 as Imaging Agent in Cancer SurgeryWILMETTE, Ill., May 13, 2021 (GLOBE NEWSWIRE) -- Monopar Therapeutics Inc. (Monopar or the Company) (NASDAQ:MNPR), a clinical-stage biopharmaceutical company primarily focused on developing proprietary therapeutics designed to extend life or improve the quality of life for cancer patients, today announced first quarter 2021 financial results and recent business updates.
Recent Business Updates
Validive
- Monopar's Phase 2b/3 VOICE clinical trial of Validive (clonidine HCl mucobuccal tablet) for the prevention of severe oral mucositis (SOM) in patients undergoing chemoradiotherapy (CRT) for oropharyngeal cancer (OPC) dosed its first patient in February 2021 and is actively recruiting patients and initiating additional clinical trial sites. There is no FDA-approved prevention or treatment for CRT-induced SOM.
- The U.S. Patent and Trademark Office (USPTO) allowed a new patent with claims for Validive covering "Clonidine and/or clonidine derivatives for use in the prevention and/or treatment of adverse side effects of chemotherapy." This patent expands coverage on the potential uses of Validive in cancer patients beyond earlier allowed claims limited specifically to the prevention and/or treatment of oral mucositis in patients receiving CRT.
Camsirubicin and Novel Analogs
- Based on the Company's current inability to gain regulatory approval to initiate the camsirubicin Phase 2 clinical trial in Spain, Monopar is evaluating alternatives to move the dose escalation run-in clinical trial forward outside of Spain. Monopar believes that it will be able to initiate the run-in clinical trial in the second half of 2021 in the U.S. or another country.
- The USPTO allowed a new patent with claims covering compositions of matter for a novel family of camsirubicin analogs (2-pyrrilino camsirubicins). This patent expires in 2038, not including any patent term extensions. The patent broadens Monopar's camsirubicin portfolio and covers a pipeline of compounds designed to retain the potentially favorable non-cardiotoxic chemical backbone of camsirubicin along with the potent broad-spectrum antitumor activity of doxorubicin. Preclinical evidence suggests that this new family of 2-pyrrilino camsirubicin analogs could be active against doxorubicin-resistant tumor cells and thereby may enable use in cancer types beyond those treatable with doxorubicin.
MNPR-101 and Related Compounds
- Progress continues in the Monopar/NorthStar Medical Radioisotopes collaboration focused on developing a novel treatment for severe COVID-19 by partnering with (1) IsoTherapeutics Group, LLC to develop, optimize and manufacture humanized urokinase plasminogen activator receptor radioimmunotherapeutics (uPRITs), (2) Aragen Bioscience, Inc. which performed studies to enable the selection of a lead candidate uPRIT along with back-up candidates to potentially advance into IND-enabling development, and (3) The University of Texas Health Science Center at Tyler and its Texas Lung Injury Institute (TLII) to perform in vitro and in vivo studies and to participate in the potential clinical development of uPRITs.
- A peer-reviewed preclinical study that reported the potential utility of MNPR-101 conjugates as uPAR imaging agents to improve surgical outcomes in bladder cancer and for surveillance post-resection was published in The European Journal of Cancer. This publication builds on previous studies using conjugates of MNPR-101 and its mouse analog, ATN-658, for the optical imaging of oral and colon cancer.
- A peer-reviewed study titled "Engineered Antibody Fragment against the Urokinase Plasminogen Activator for Fast Delineation of Triple-Negative Breast Cancer by Positron Emission Tomography" demonstrated the potential to identify breast cancers with urokinase plasminogen activator (uPA) overexpression, and monitor uPA expression during treatment using positron emission tomography (PET) imaging along with the Company's uPA antibody fragment radiotracer.
Results for the First Quarter Ended March 31, 2021 Compared to the First Quarter Ended March 31, 2020
Cash and Net Loss
Cash and cash equivalents as of March 31, 2021 were $25.7 million. Monopar anticipates that its current cash and cash equivalents, which includes $10.9 million of net proceeds raised in the first quarter of 2021 under the Company's Capital on DemandTM Sales Agreement with JonesTrading Institutional Services, at an average gross price per share of $10.20, will fund the Company's major programs at least through June 2022, including: funding and completing the Phase 2b portion of the VOICE clinical trial and commencing of the Phase 3 portion; funding the camsirubicin run-in clinical trial; continuing advancement of the COVID-19 uPRIT program; and developing other MNPR-101 related compounds and technologies. The Company plans to raise additional funds and/or engage a partner within the next 12 months to complete the VOICE clinical program and continue the camsirubicin clinical development beyond the run-in clinical trial.
Net loss for the first quarter of 2021 was $1.9 million or $0.16 per share compared to net loss of $1.1 million or $0.10 per share for the first quarter of 2020.
Research and Development (R&D) Expenses
R&D expenses for the first quarter of 2021 were $1.2 million compared to $0.3 million for the first quarter of 2020. This increase of $0.9 million was primarily attributed to increases of (1) $0.3 million for the planning of the GEIS-sponsored camsirubicin Phase 2 clinical trial including drug product manufacturing, (2) $0.3 million for R&D personnel expenses, (3) $0.2 million for the VOICE clinical trial and manufacturing-related expenses, and (4) $0.1 million for other R&D operating expenses.
General and Administrative (G&A) Expenses
G&A expenses for the first quarter of 2021 were $0.7 million, a nominal decrease from $0.8 million of G&A expenses for the first quarter of 2020.
About Monopar Therapeutics
Monopar Therapeutics is a clinical-stage biopharmaceutical company primarily focused on developing proprietary therapeutics designed to extend life or improve the quality of life for cancer patients. The Company's pipeline consists of Validive® for the prevention of chemoradiotherapy-induced severe oral mucositis in oropharyngeal cancer patients; camsirubicin for the treatment of advanced soft tissue sarcoma; and a preclinical-stage uPAR targeted antibody, MNPR-101, for advanced cancers and severe COVID-19. For more information, and links to SEC filings that contain detailed financial information, visit: https://ir.monopartx.com/quarterly-reports.
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 whether the recently issued patents would provide protection for development and commercialization in potential future indications, our ability to begin the camsirubicin run-in clinical trial in the second half of 2021, whether the Monopar/NorthStar collaboration will be successful in developing a uPRIT to treat severe COVID-19 with its development partners and whether the Company's current cash and cash equivalents will fund the Company's major programs through June 2022. The forward-looking statements involve risks and uncertainties including, but not limited to, not successfully recruiting patients and initiating additional clinical trial sites for the VOICE clinical trial or the camsirubicin clinical program within expected timeframes, if at all; the Company's inability to raise sufficient funds or engage a partner to complete the Phase 3 portion of the VOICE clinical trial and continue the camsirubicin clinical program; not successfully developing a COVID-19 uPRIT with the Company's development collaborators and not successfully developing MNPR-101 conjugates and related compounds for various potential indications and technologies. 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
Kim R. Tsuchimoto
Chief Financial Officer
[email protected]Follow Monopar on social media for updates:
Twitter: @MonoparTx LinkedIn: Monopar Therapeutics
- Monopar's Phase 2b/3 VOICE clinical trial of Validive (clonidine HCl mucobuccal tablet) for the prevention of severe oral mucositis (SOM) in patients undergoing chemoradiotherapy (CRT) for oropharyngeal cancer (OPC) dosed its first patient in February 2021 and is actively recruiting patients and initiating additional clinical trial sites. There is no FDA-approved prevention or treatment for CRT-induced SOM.
-
View Full Article Hide Full Article
− NorthStar has provided reliable molybdenum-99 (Mo-99)/technetium-99m (Tc-99m) supply for more than two years as the only U.S. commercial Mo-99 producer
− Second NorthStar Mo-99 production and processing facility nearing completion ensuring even more reliable supply and additional Mo-99 production capability
− RadioGenix® System sales continue growth, reliably providing hundreds of thousands of Tc-99m doses to inform patient healthcare needs in diagnostic imaging
− Commercial scale-up activities for therapeutic radioisotopes actinium-225 (Ac-225) and copper-67 (Cu-67) production underway with multiple supply relationships in place; SPECT imaging candidate FibroScint holds potential across multiple cardiovascular indications; additional SPECT opportunities in evaluation
− Strategic collaborations with IBA and Monopar Therapeutics target unmet needs for global Tc-99m availability and radiotherapeutic agent for severe COVID-19 and acute respiratory diseases, respectively
NorthStar Medical Radioisotopes, LLC, a global innovator in the development, production and commercialization of radiopharmaceuticals used for medical imaging and therapeutic applications, today announced a corporate update highlighting progress across its key programs during the past twelve months and upcoming milestones.
This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20210413005431/en/
NorthStar Medical Radioisotopes, Beloit, Wisconsin campus (Photo: Business Wire)
"NorthStar has made significant advancements across our portfolio over the past year and we are excited about the Company's future," said Stephen Merrick, President and Chief Executive Officer of NorthStar Medical Radioisotopes. "In advancing our plans to ensure reliable, non-uranium based radioisotope supply for the United States, RadioGenix System (technetium Tc 99m generator) sales continue to increase. Our facility expansions, designed to ensure additional production capacity and supply of Mo-99, are nearing completion. Additionally, NorthStar has broadened its technology platform to address critical unmet needs in radioisotope supply by advancing commercial-scale development of promising therapeutic radioisotopes, and our novel cardiovascular SPECT imaging agent, FibroScint, is advancing towards eIND-enabling studies. We are collaborating with IBA to increase global availability of Tc-99 and with Monopar Therapeutics to develop a targeted radiotherapeutic agent for severe COVID-19 and other acute respiratory diseases. NorthStar anticipates sustained progress and growth as we expand our horizons globally and execute strongly in our mission to provide reliable radioisotope supply to support patients' healthcare needs."
Corporate development and industry leadership
NorthStar is firmly positioned for long term growth and increasing global industry leadership.- In March 2021, NorthStar implemented organizational changes to drive focused growth for its therapeutic and specialized SPECT radioisotopes business. The new structure enables NorthStar to advance its radioisotope development and commercialization planning efforts in parallel with ongoing expansion programs for increased U.S. Mo-99 capacity and production. In conjunction with other organizational changes, NorthStar appointed Dave Wilson, RPh, BCNP, as Vice President, Advanced Radiopharmaceutical and Therapeutic Technologies to lead these initiatives to commercialization.
- In October 2020, NorthStar promoted Chief Financial Officer Paul Estrem to Executive Vice President and he was appointed to the NorthStar Board of Managers. Mr. Estrem has been instrumental in building momentum to create and expand NorthStar's product portfolio. The expanded role positions him to guide NorthStar's corporate strategy and drive its planned corporate and business development initiatives.
- NorthStar is a widely recognized leader in radioisotope technology development and commercialization and the nuclear medicine industry. In July 2020, NorthStar led an update on its ongoing commercial Mo-99 production, expansion plans and the RadioGenix System at the Society of Nuclear Medicine and Molecular Imaging (SNMMI) event, "Industry Outlook on Current and Future Mo-99 Supply." In September 2020, then-Deputy Secretary of Energy Mark W. Menezes visited NorthStar to learn about its U.S.-based Mo-99 production, underscoring the Department of Energy's commitment to reviving and expanding the U.S. nuclear sector and to reduce dependence on foreign imports while bringing new opportunities to the heartland.
RadioGenix System commercial progress
NorthStar's innovative, high tech radioisotope separation platform, the RadioGenix System, uses U.S.-produced, non-uranium based Mo-99 to produce Tc-99m, the most widely used medical radioisotope that informs patient management decisions in 40,000 U.S. imaging studies daily.- RadioGenix System sales continue to steadily increase, with hundreds of thousands of doses provided for patients' diagnostic imaging studies to date. Since becoming commercially available, RadioGenix Systems have provided reliable Tc-99m supply for customers with U.S.-produced Mo-99, despite intermittent shortages from suppliers using legacy, uranium-based production methods.
- Ongoing product development programs continue to maximize operational utility and efficiency in producing Tc-99m. Since initial approval in 2018, NorthStar has received five subsequent Food and Drug Administration (FDA) approvals, the latest in January 2021 for concentrated Mo-98 and RadioGenix System updates.
Commercial U.S. Mo-99 manufacturing and production expansion
NorthStar is the only commercialized U.S. producer of Mo-99. It is aggressively expanding and establishing dual production and processing hubs for additional Mo-99 capacity to better meet customer demand and to ensure sustainable U.S. supply. Two facility expansion projects nearing completion in Beloit, Wisconsin, will augment current Mo-99 production and processing in Columbia, Missouri, conducted in partnership with the University of Missouri Research Reactor (MURR®).- NorthStar's Isotope Processing facility in Beloit will complement current Columbia processing capacity for Mo-99 source vessels. The facility will enable NorthStar to more than double its production of Mo-99, used with RadioGenix Systems to produce Tc-99m. Equipment installation is nearing completion, testing is underway with full qualification to be completed by the end of 2021. NorthStar expects FDA approval for the Beloit Isotope Processing facility in 2022.
- NorthStar's Accelerator Production facility expansion in Beloit will ensure additional Mo-99 capacity, enable flexible production scheduling and minimize customer supply risks. Like other NorthStar processes, accelerator production of Mo-99 using the "neutron knock-out" method is non-uranium based and highly efficient. The first pair of IBA electron beam accelerators will arrive for installation at NorthStar's facility in April 2021. The Company anticipates accelerator production to begin in 2023, pending appropriate licensure and FDA approval.
- In January 2021, the FDA approved NorthStar's process for producing Mo-99 from concentrated Mo-98 and related software updates for the RadioGenix System. This approval is the first and only commercial-scale production of Mo-99 using concentrated Mo-98 technology. It increases NorthStar's Mo-99 production capacity up to four times above its current technology, to provide higher activity source vessels to better meet customer demand.
- FDA approval of concentrated Mo-98 allows NorthStar to serve as much as 40% of the U.S. demand for Mo-99 by the end of 2021. The Company expects that within three to five years, it will have the capability to regularly supply an estimated 65% of U.S. Mo-99 demand, and up to 100% of U.S. demand in an emergency.
Commercial-scale therapeutic radioisotope production − Ac-225 and Cu-67
NorthStar is poised to be the first commercial-scale supplier of the important therapeutic radioisotopes Ac-225 and Cu-67, both used to directly target and deliver therapeutic doses of radiation to destroy cancer cells in patients with serious disease. Current production technology limitations and resultant limited supply have severely constrained development of these promising therapies.- NorthStar is applying its commercial-scale radioisotope production expertise to provide reliable Ac-225 and Cu-67 supply to advance clinical research and for commercial radiopharmaceutical products. The Company is leveraging the same technology expertise demonstrated by the successful launch of the RadioGenix System and non-uranium based Mo-99 supply.
- NorthStar has relationships in place with several large pharmaceutical companies to provide clinical trial supply and commercial-scale quantities of Ac-225 and Cu-67. The Company expects to secure long-term supply agreements during 2021.
Specialized SPECT portfolio
NorthStar is actively developing and growing its strategic portfolio of specialized single photon emission computed tomography (SPECT) radiopharmaceuticals to meet increasing clinical needs for SPECT imaging, driven by scientific advancements in cardiology and oncology.- NorthStar has an exclusive, global licensing agreement with Capella Imaging, Inc. for FibroScint, a novel fibrin-specific diagnostic imaging agent labeled with Tc-99m for SPECT imaging. Pending successful development, FibroScint will have an initial application in the imaging of thrombus (blood clots) associated with left ventricular assist devices (LVADs), and other potential imaging applications in deep vein thrombosis and pulmonary embolism. NorthStar intends to use RadioGenix System-produced Tc-99m in planned clinical studies of FibroScint. Advanced preclinical development is underway, with an exploratory Investigational New Drug (IND) filing for a Phase 1 study planned for early 2022.
- NorthStar is evaluating additional potential opportunities in specialized SPECT radiopharmaceuticals to address unmet healthcare needs and synergies with its product portfolio.
Partnerships and collaborations
NorthStar selectively partners with leading organizations in strategic collaborations designed to augment its portfolio, maximize synergies and drive growth in areas of unmet medical need.- In June 2020, NorthStar and Monopar Therapeutics Inc. (NASDAQ:MNPR) announced a collaboration to help combat severe COVID-19 and other severe respiratory diseases. The collaboration will couple Monopar's targeted monoclonal antibody MNPR-101 to a therapeutic radioisotope supplied by NorthStar to create a highly selective agent with potential to spare healthy cells while quickly reducing cytokine storms and their harmful systemic effects. In December 2020, Monopar and NorthStar announced that a clinical candidate was selected, enabling preclinical studies to begin and advancing one step closer to reaching human clinical trials.
- In March 2021, NorthStar and IBA (Ion Beam Applications S.A., EURONEXT) announced a collaboration to increase global availability of Tc-99m, with potential to result in non-uranium Mo-99 being the leading worldwide source of Tc-99m. Worldwide, diagnostic imaging studies using Tc-99m inform healthcare decisions for approximately 30 million patients annually. The collaboration enables companies outside the United States to access Tc-99m Generation Systems (TCM Generation Systems) that utilize NorthStar's proprietary non-uranium based Mo-99 produced using IBA's accelerators and beamlines. Early discussions with interested companies are underway.
About the RadioGenix® System (Technetium Tc 99m Generator)
The RadioGenix System is an innovative, high tech separation platform that is approved for processing non-uranium based molybdenum-99 (Mo-99) for the production of the important medical radioisotope, technetium-99m (Tc-99m). Prior to availability of RadioGenix technology, the U.S. supply chain for Mo-99 has been subject to frequent and sometimes severe interruptions which negatively impact patient healthcare. Approved by the U.S. Food and Drug Administration (FDA) in 2018, the RadioGenix System is the first and only on-site, automated isotope separation system of its kind for use with non-uranium based Mo-99, designed to help alleviate shortage situations and expand domestic supply.Indication and Important Risk Information about the RadioGenix® System and Sodium Pertechnetate Tc 99m Injection USP
The RadioGenix® System is a technetium Tc-99m generator used to produce Sodium Pertechnetate Tc 99m Injection, USP. Sodium Pertechnetate Tc 99m Injection is a radioactive diagnostic agent and can be used in the preparation of FDA-approved diagnostic radiopharmaceuticals.
Sodium Pertechnetate Tc 99m Injection is also indicated in
- Adults for Salivary Gland Imaging and Nasolacrimal Drainage System Imaging (dacryoscintigraphy).
- Adults and pediatric patients for Thyroid Imaging and Vesicoureteral Imaging (direct isotopic cystography) for detection of vesicoureteral reflux.
IMPORTANT RISK INFORMATION
- Allergic reactions (skin rash, hives, or itching) including anaphylaxis have been reported following the administration of Sodium Pertechnetate Tc 99m Injection. Monitor all patients for hypersensitivity reactions.
- Radiation risks associated with the use of Sodium Pertechnetate Tc 99m Injection are greater in children than in adults and, in general, the younger the child, the greater the risk owing to greater absorbed radiation doses and longer life expectancy. These greater risks should be taken firmly into account in all benefit-risk assessments involving children. Long-term cumulative radiation exposure may be associated with an increased risk of cancer.
- Unintended Re-186 Exposure: Discard the first eluate from every new Potassium Molybdate Mo-99 Source Vessel to minimize the risk of unintended radiation exposure from Rhenium Re-186.
- Temporarily discontinue breastfeeding. A lactating woman should pump and discard breastmilk for 12 to 24 hours after Sodium Pertechnetate Tc 99m Injection administration.
- Sodium Pertechnetate Tc 99m Injection should be given to pregnant women only if the expected benefits to be gained clearly outweigh the potential hazards.
- Only use potassium molybdate Mo-99, processing reagents, saline and other supplies, including kit/packs, provided by NorthStar Medical Radioisotopes. Do not administer Sodium Pertechnetate Tc 99m Injection after the 0.15 microCi of Mo-99/mCi of Tc-99m limit has been reached or when the 24 hour expiration time from elution is reached, whichever occurs earlier.
To report SUSPECTED ADVERSE REACTIONS, contact NorthStar® Medical Radioisotopes, LLC at 1-844-438-6659; or FDA at 1-800-332-1088 or www.fda.gov/medwatch.
For RadioGenix® System version 1.2 Full Prescribing Information, click here or visit https://www.northstarnm.com/wp-content/uploads/2020/12/radiogenix-system-12-package-insert-rev-03-29-dec-2020.pdf.
About NorthStar Medical Radioisotopes, LLC (NorthStar)
NorthStar Medical Radioisotopes is a commercial-stage nuclear medicine company that develops, produces and manufactures reliable and environmentally-friendly diagnostic and therapeutic radiopharmaceuticals. Its first FDA-approved diagnostic imaging product is technetium-99m (Tc-99m), which is used in 40,000 patient imaging studies per day in the United States as standard of care to assess extent and severity of heart disease and cancer. Tc-99m is generated by NorthStar's novel RadioGenix ® System (technetium Tc 99m generator) which uses U.S.-produced, non-uranium based molybdenum-99 (Mo-99) as its source material. The Company is executing a well-defined plan to consistently increase the scale of Mo-99 production and to continuously improve efficiencies to meet anticipated increased demand. Therapeutic radioisotopes are increasingly important cancer treatment options, and NorthStar is developing commercial-scale production technologies to meet high demand for their use in ongoing clinical trials by multiple pharmaceutical companies. In addition, the Company is advancing a portfolio of other radiopharmaceuticals for use in therapeutic and diagnostic applications. For more information, visit: www.northstarnm.com.View source version on businesswire.com: https://www.businesswire.com/news/home/20210413005431/en/
-
View Full Article Hide Full Article
WILMETTE, Ill., March 30, 2021 (GLOBE NEWSWIRE) -- Monopar Therapeutics Inc. (NASDAQ:MNPR), a clinical-stage biopharmaceutical company primarily focused on developing proprietary therapeutics designed to extend life or improve the quality of life for cancer patients, today announced the publication of a peer-reviewed study titled "Engineered Antibody Fragment against the Urokinase Plasminogen Activator for Fast Delineation of Triple-Negative Breast Cancer by Positron Emission Tomography." Urokinase plasminogen activator (uPA) is an established biomarker in current breast cancer clinical practice guidelines and its presence is used to select appropriate drug treatment. This study demonstrates the potential to identify breast cancers with uPA overexpression and monitor uPA activity during treatment using PET imaging and Monopar's uPA antibody fragment radiotracer. Monopar has a panel of proprietary antibodies and antibody fragments to uPA and its receptor uPAR (such as MNPR-101).
uPA and its receptor uPAR work together to drive aggressive tumor invasion, leading to metastasis, morbidity, and mortality in breast and other cancers. However, uPA is difficult to measure and currently requires a substantial amount of fresh frozen tissue. Monopar's antibody fragment (ATN-291 F(ab')2) conjugated to a copper radiotracer enabled rapid PET visualization of tumors with uPA overexpression in a human breast cancer model in mice. PET imaging may expand the current application of uPA as a breast cancer biomarker and enable the monitoring of tumor uPA expression during treatment.
"The publication demonstrates the potential utility of Monopar's uPA antibody fragments as imaging agents in a model of aggressive triple negative breast cancer," said Andrew Mazar, PhD, Chief Scientific Officer of Monopar and a co-author of the study. "Same-day PET imaging may guide treatment decisions for breast cancer, and potentially other solid cancers, given the established role of uPA in this disease."
"We are pleased with the results of this peer-reviewed study," said Chandler Robinson, MD, Chief Executive Officer of Monopar, "and we look forward to exploring the potential of our versatile panel of uPA/uPAR targeted monoclonal antibodies in cancer imaging, cancer treatment, and other possible applications."
About Monopar Therapeutics Inc.
Monopar Therapeutics is a clinical-stage biopharmaceutical company primarily focused on developing proprietary therapeutics designed to extend life or improve the quality of life for cancer patients. Monopar's pipeline consists of Validive® for the prevention of chemoradiotherapy-induced severe oral mucositis in oropharyngeal cancer patients; camsirubicin for the treatment of advanced soft tissue sarcoma; and a late-stage preclinical antibody, MNPR-101, for advanced cancers and severe COVID-19. 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 potential for same-day PET imaging of breast cancer, including aggressive triple negative breast cancer, using Monopar's uPA-targeted antibody fragment (ATN-291 F(ab')2), whether PET imaging may expand the current application of uPA as a biomarker for breast cancer and enable the monitoring of tumor uPA expression during treatment, and the potential of Monopar's versatile panel of uPA/uPAR targeted monoclonal antibodies in cancer imaging, cancer treatment, and other possible applications. The forward-looking statements involve risks and uncertainties including, but not limited to: the lack of any clinical activities to date with respect to Monopar's uPA targeted antibody fragments; that Monopar's MNPR-101 and related compound preclinical development activities to date have been focused on the treatment of cancers and not imaging medical devices; the requirement for additional capital to complete preclinical and clinical development of a medical device utilizing Monopar's uPA antibody fragments, and if successful, commercialization; if funding is available, not being able to successfully develop Monopar's antibody fragments for use as uPA imaging agents in triple negative breast cancer detection, or any other uses or indications; not being able to ensure volumes of ATN-291 F(ab') 2) conjugates or its derivatives can be manufactured and scaled up to meet potential demand; uncertainties about levels of demand if and when a medical device is available for commercialization and the significant general risks and uncertainties surrounding the research, development, regulatory approval and commercialization of medical devices. 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
[email protected]Follow Monopar on social media for updates:
Twitter: @MonoparTx
LinkedIn: Monopar Therapeutics
-
View Full Article Hide Full Article
Validive® Phase 2b/3 VOICE Clinical Trial Commenced
Camsirubicin Phase 2 Clinical Trial Anticipated to Start in Q2 2021
MNPR-101-Conjugate Data Published in European Journal of CancerWILMETTE, Ill., March 25, 2021 (GLOBE NEWSWIRE) -- Monopar Therapeutics Inc. (Monopar or the Company) (NASDAQ:MNPR), a clinical-stage biopharmaceutical company primarily focused on developing proprietary therapeutics designed to extend life or improve the quality of life for cancer patients, today announced fourth quarter and full-year 2020 financial results and recent business updates.
Recent Business Updates
Lead Product Candidate Validive
- Monopar's Phase 2b/3 VOICE clinical trial of Validive (clonidine HCl mucobuccal tablet) for the prevention of severe oral mucositis (SOM) in patients undergoing chemoradiotherapy (CRT) for oropharyngeal cancer (OPC) dosed its first patient in February 2021 and is actively recruiting patients and initiating additional clinical trial sites. There is no FDA-approved prevention or treatment for CRT-induced SOM.
- The U.S. Patent and Trademark Office (USPTO) allowed patent claims for Validive, covering "Clonidine and/or clonidine derivatives for use in the prevention and/or treatment of adverse side effects of chemotherapy." This patent expands coverage on the potential use of Validive in cancer patients beyond earlier allowed claims specifically for the prevention of oral mucositis in patients receiving CRT.
Camsirubicin
- The Phase 2 clinical trial of camsirubicin is anticipated to commence enrollment in the second quarter of 2021. Monopar's clinical development collaborator, Grupo Español de Investigación en Sarcomas (GEIS), will lead the multi-country, randomized, open-label Phase 2 clinical trial evaluating camsirubicin head-to-head against standard-of-care doxorubicin in patients with advanced soft tissue sarcoma (ASTS).
- The trial will begin with an open-label dose escalation "run-in" prior to the randomization portion of the trial. The primary endpoint of the trial will be progression-free survival, with secondary endpoints including overall survival, response rate, and incidence of treatment-emergent adverse events.
- The USPTO allowed patent claims covering compositions of matter (2-pyrrilino camsirubicin) for a novel family of camsirubicin analogs. This patent expires in 2038, not including any patent term extensions. The patent broadens Monopar's camsirubicin portfolio and covers a pipeline of compounds designed to retain the potentially favorable non-cardiotoxic chemical backbone of camsirubicin along with the potent broad-spectrum antitumor activity of doxorubicin. Preclinical evidence suggests that this new family of 2-pyrrilino camsirubicin analogs could be active against doxorubicin-resistant tumor cells which may enable use in cancer types beyond those treatable with camsirubicin.
MNPR-101 and Related Compounds
- Progress continues in the Monopar/NorthStar Medical Radioisotopes collaboration focused on developing a novel treatment for severe COVID-19 by partnering with (i) IsoTherapeutics Group, LLC to develop and manufacture humanized urokinase plasminogen activator receptor radioimmunotherapeutics (uPRITs), (ii) Aragen Bioscience, Inc. which performed studies to enable the selection of a lead candidate uPRIT along with back-up candidates to potentially advance into IND-enabling development, and (iii) The University of Texas Health Science Center at Tyler and its Texas Lung Injury Institute (TLII) to perform in vitro and in vivo studies and to participate in the clinical development of uPRITs.
- The European Journal of Cancer published a peer-reviewed preclinical study which shows the potential utility of MNPR-101 conjugates as uPAR imaging agents to improve surgical outcomes in bladder cancer and for surveillance post-resection.
Results for the Fourth Quarter and Year Ended December 31, 2020 Compared to the Fourth Quarter and Year Ended December 31, 2019
Cash and Net Loss
Cash and cash equivalents as of December 31, 2020 were $16.7 million. Monopar anticipates that its current cash and cash equivalents, which includes an additional $10.9 million of net proceeds raised in the first quarter of 2021 under the Company's Capital on Demand® Sales Agreement with JonesTrading Institutional Services, at an average gross price per share of $10.20, will fund the Company's planned operations at least through March 2022. Planned operations include funding and completing the Phase 2b portion of the Validive "VOICE" clinical trial and commencing of the Phase 3 portion; the funding of the run-in portion of the GEIS Phase 2 camsirubicin clinical trial; and continuation of the development of the COVID-19 uPRIT program along with other MNPR-101 related compounds. The Company plans to raise additional funds or engage a partner in the next 12 months to complete the VOICE clinical program and continue the GEIS camsirubicin clinical trial beyond the run-in phase.
Net loss for the fourth quarter of 2020 was $2.1 million or $0.19 per share compared to net loss of $1.2 million or $0.13 per share for the fourth quarter of 2019. Net loss for the year ended December 31, 2020 was $6.3 million or $0.58 per share compared to net loss of $4.2 million or $0.45 per share for the year ended December 31, 2019.
Research and Development (R&D) Expenses
R&D expenses for the fourth quarter of 2020 were $1.6 million compared to $0.6 million for the fourth quarter of 2019. This increase of $1.0 million is primarily attributed to increases in expenses of $0.5 million for the planning of the GEIS camsirubicin Phase 2 clinical trial including manufacturing, $0.2 million for the VOICE clinical trial planning and manufacturing costs, and $0.3 million for R&D personnel salary and benefits.
R&D expenses for the year ended December 31, 2020 were $4.1 million compared to $2.0 million for the year ended December 31, 2019. This represents an increase of approximately $2.1 million primarily attributed to increases in expenses of $1.1 million for the planning of the GEIS camsirubicin Phase 2 clinical trial including manufacturing, $0.1 million for the VOICE clinical trial planning and manufacturing costs, and $0.9 million for R&D personnel salary and benefits.
General and Administrative (G&A) Expenses
G&A expenses for the fourth quarter of 2020 were $0.6 million, equal to $0.6 million for the fourth quarter of 2019.
G&A expenses for the year ended December 31, 2020 were $2.4 million, equal to $2.4 million for the year ended December 31, 2019.
About Monopar Therapeutics
Monopar Therapeutics is a clinical-stage biopharmaceutical company primarily focused on developing proprietary therapeutics designed to extend life or improve the quality of life for cancer patients. The Company's pipeline consists of Validive® for the prevention of chemoradiotherapy-induced severe oral mucositis in oropharyngeal cancer patients; camsirubicin for the treatment of advanced soft tissue sarcoma; and a preclinical stage uPAR targeted antibody, MNPR-101, for advanced cancers and severe COVID-19. For more information, and links to SEC filings that contain detailed financial information, visit: https://ir.monopartx.com/quarterly-reports.
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 whether the recently issued patents would provide protection for development and commercialization in potential future indications, GEIS's ability to begin the camsirubicin Phase 2 clinical trial in the second quarter of 2021, whether the Monopar/NorthStar collaboration will be successful in developing a uPRIT to treat severe COVID-19 with its development partners and whether the Company's current cash and cash equivalents will fund the Company's planned operations through March 2022. The forward-looking statements involve risks and uncertainties including, but not limited to, not successfully recruiting patients and initiating additional clinical trial sites for the VOICE clinical trial or the Phase 2 GEIS-sponsored camsirubicin clinical trial within expected timeframes, if at all; the Company's inability to raise sufficient funds or engage a partner to complete the Phase 3 portion of the VOICE clinical trial and continue the GEIS camsirubicin trial, and not successfully developing a COVID-19 uPRIT with the Company's development collaborators. 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
Kim R. Tsuchimoto
Chief Financial Officer
[email protected]Follow Monopar on social media for updates:
Twitter: @MonoparTx LinkedIn: Monopar Therapeutics - Monopar's Phase 2b/3 VOICE clinical trial of Validive (clonidine HCl mucobuccal tablet) for the prevention of severe oral mucositis (SOM) in patients undergoing chemoradiotherapy (CRT) for oropharyngeal cancer (OPC) dosed its first patient in February 2021 and is actively recruiting patients and initiating additional clinical trial sites. There is no FDA-approved prevention or treatment for CRT-induced SOM.
-
View Full Article Hide Full Article
WILMETTE, Ill., March 02, 2021 (GLOBE NEWSWIRE) -- Monopar Therapeutics Inc. (NASDAQ:MNPR), a clinical-stage biopharmaceutical company primarily focused on developing proprietary therapeutics designed to extend life or improve the quality of life for cancer patients, today announced it has entered into an agreement with serial medtech entrepreneur, Andrew Cittadine, to explore over the next few months strategic and developmental options for MNPR-101 as an intraoperative imaging agent in bladder cancer surgery as well as other cancers.
Mr. Cittadine is an experienced healthcare executive with a track record of building new businesses from concept through acquisition, including successful exits of Sensant Corp. to Siemens and American Biooptics to Olympus. Mr. Cittadine was the co-founder and Vice President of Marketing at Sensant Corp., and co-founder and CEO of American Biooptics. Sensant was an oncology imaging startup that developed 3D ultrasound imaging systems, and American Biooptics was a startup that developed an advanced oncology diagnostic test for gastrointestinal cancers. His most recent endeavors include serving as the CEO of Diagnostic Photonics, an imaging systems company for cancer surgeries.
"It is a strong fit," said Chandler Robinson, MD, Chief Executive Officer of Monopar, speaking to Mr. Cittadine's expertise and the recent MNPR-101 bladder cancer imaging data published in a peer-reviewed article in the European Journal of Cancer.
"Mr. Cittadine's extensive experience in the oncology diagnostics and surgical imaging space combined with his previous successes makes for an ideal collaboration on exploring the potential of MNPR-101," said Andrew Mazar, PhD, Chief Scientific Officer of Monopar.
"The MNPR-101 based imaging agent has shown early promise in in vivo human bladder cancer models. I am excited to work with the Monopar team exploring ways to further the development of MNPR-101, be it through a spin-out, an out-licensing, a partnership, or developing it in-house," said Andrew Cittadine, MBA.
About Monopar Therapeutics Inc.
Monopar Therapeutics is a clinical-stage biopharmaceutical company primarily focused on developing proprietary therapeutics designed to extend life or improve the quality of life for cancer patients. Monopar's pipeline consists of Validive for the prevention of chemoradiotherapy-induced severe oral mucositis in oropharyngeal cancer patients; camsirubicin for the treatment of advanced soft tissue sarcoma; and a late-stage preclinical antibody, MNPR-101, for advanced cancers and severe COVID-19. 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. The forward-looking statements involve risks and uncertainties including, but not limited to the lack of any clinical activities to date with respect to MNPR-101 and that preclinical development activities to date have been focused on the treatment of cancers and not medical devices; the inability to successfully spin-out, out-license or develop a partnership, or if developed in-house, the requirement for additional capital to complete preclinical and clinical development of a medical device utilizing MNPR-101, and if successful, commercialization; if funding is available, not being able to develop MNPR-101 for use as a uPAR imaging agent in bladder cancer or any other indications; not being able to ensure volumes of MNPR-101 conjugates can be manufactured and scaled up to meet potential demand; uncertainties about levels of demand if and when a medical device is available for commercialization and the significant general risks and uncertainties surrounding the research, development, regulatory approval and commercialization of medical devices. 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
[email protected]Follow Monopar on social media for updates:
@MonoparTx Monopar Therapeutics