Welcome to our dedicated page for Monopar Therapeutics news (Ticker: MNPR), a resource for investors and traders seeking the latest updates and insights on Monopar Therapeutics stock.
Monopar Therapeutics Inc. (MNPR) is a clinical-stage biopharmaceutical company whose news flow centers on drug development milestones, scientific data presentations, financial updates, and capital markets activity. Public communications describe a focus on late-stage ALXN1840 for Wilson disease and MNPR-101-based radiopharmaceutical programs for imaging and treating advanced cancers.
News items for Monopar commonly include clinical and scientific results, such as data from the ALXN1840-WD-204 copper balance study and pooled long-term neurological and safety analyses in Wilson disease. The company also reports on presentations at major medical meetings, including the American Association for the Study of Liver Diseases (AASLD) – The Liver Meeting and the American Neurological Association (ANA) Annual Meeting, as well as publications in peer-reviewed journals like the Journal of Hepatology.
Investors and observers can also find updates on radiopharmaceutical programs, including progress in Phase 1 imaging and therapeutic trials with MNPR-101-Zr and MNPR-101-Lu, and regulatory developments such as U.S. Food and Drug Administration authorization for an Expanded Access Program in advanced solid tumors. In addition, Monopar issues press releases on financial results, describing quarterly performance, research and development spending, and general and administrative expenses, alongside information on cash resources and capital-raising transactions.
Further topics in Monopar’s news include capital markets events, such as underwritten offerings of common stock and pre-funded warrants, share repurchase agreements with existing stockholders, and inclusion in the Russell 3000 and Russell 2000 indexes. Readers interested in MNPR news can use this page to follow these developments and review how the company describes the evolution of its Wilson disease and radiopharmaceutical programs over time.
Monopar Therapeutics (Nasdaq: MNPR) has appointed Laura Kelly as the new Director of Clinical Operations. With extensive experience in clinical research, particularly in oncology, she will oversee the Phase 2b/3 VOICE trial for Validive and other clinical programs. CEO Chandler Robinson emphasized her role is timely given the company's development efforts. Her leadership is expected to enhance clinical trial execution and enrollment. This strategic appointment aims to strengthen Monopar's capabilities in advancing its pipeline for cancer therapies.
Monopar Therapeutics (Nasdaq: MNPR) announced the dosing of the first patient in its Phase 2b/3 VOICE trial for Validive aimed at preventing chemoradiotherapy-induced severe oral mucositis (SOM) in oropharyngeal cancer patients. Validive's formulation allows for easy self-administration and targets a significant unmet need as approximately 40,000 patients in the US suffer from SOM annually. The previous Phase 2 trial indicated a 40% reduction in SOM incidence with Validive. The current trial plans to enroll around 260 patients.
Monopar Therapeutics Inc. (Nasdaq: MNPR) has published a peer-reviewed study in the European Journal of Cancer, highlighting the potential of MNPR-101 as a uPAR imaging agent to enhance surgical outcomes in bladder cancer. The study indicates that MNPR-101 may assist surgeons in better visualizing tumor boundaries, potentially resulting in more successful tumor resections. Given that bladder cancer has a high recurrence rate, the development of this imaging probe could significantly impact treatment efficacy if validated in clinical settings.
Monopar Therapeutics Inc. (Nasdaq: MNPR) announced a new patent for MNPR-101 in Canada, enhancing its global patent protection, which already includes the US, Europe, and Japan. MNPR-101 is a first-in-class antibody targeting the urokinase Plasminogen Activator Receptor (uPAR), prevalent in certain cancer types. This patent allows Monopar to expand its research on MNPR-101, which may also be utilized in treating severe COVID-19. The company is strategically positioned to explore MNPR-101's potential in multiple therapeutic areas.
Monopar Therapeutics (Nasdaq: MNPR) announced the issuance of a new U.S. patent (US 10,450,340), enhancing its camsirubicin intellectual property portfolio, which may expire in 2038. This patent covers a novel family of 2-pyrrilino camsirubicin analogs designed to maintain a non-cardiotoxic profile while exhibiting broad-spectrum antitumor activity. The company is on track to initiate a Phase 2 clinical trial in early 2021, evaluating camsirubicin against doxorubicin for advanced soft tissue sarcoma. Successful development could lead to better patient outcomes by overcoming dosing limitations associated with doxorubicin.
Monopar Therapeutics (Nasdaq: MNPR) and NorthStar Medical Radioisotopes announced the selection of a uPRIT clinical candidate aimed at treating severe COVID-19. This candidate, derived from Monopar's proprietary antibody MNPR-101, targets uPAR, which is associated with pro-inflammatory immune responses. The candidate is now advancing into IND-enabling studies, with preclinical trials forthcoming. The collaboration emphasizes the urgency of developing effective treatments alongside vaccines for COVID-19 patients.
Monopar Therapeutics (MNPR) announced the initiation of its Phase 2b/3 VOICE clinical trial for Validive®, aimed at preventing severe oral mucositis (SOM) in oropharyngeal cancer patients undergoing chemoradiotherapy. The trial is actively recruiting up to 260 patients across multiple sites, following a completed Phase 2 trial that showed a 40% reduction in SOM incidence among those treated with Validive. With more than 40,000 new cases expected in the U.S. in 2021, there is a significant unmet medical need for effective SOM therapies.
Monopar Therapeutics (MNPR) announced key updates from its third quarter 2020. The Phase 2b/3 clinical trial of its lead product, Validive, targeting severe oral mucositis, is set to start before year-end. New patents have been issued for Validive, enhancing its market position. Additionally, a Phase 2 clinical trial for camsirubicin is anticipated to begin by early 2021. As of September 30, 2020, the company holds $18.0 million in cash, expected to fund operations through 2021. However, fundraising will be essential for the Phase 3 trial of Validive.
Monopar Therapeutics (Nasdaq: MNPR) has announced the issuance of new patents for Validive, its lead product candidate, which is currently in Phase 2b/3 trials. The patents extend protection to 2035, enhancing Validive’s use in preventing adverse chemotherapy effects such as gastrointestinal and respiratory disorders. With around 650,000 U.S. cancer patients undergoing chemotherapy annually, this expands Validive's application beyond oral mucositis treatment. The clinical trial for oropharyngeal cancer patients is set to commence by year-end 2020.
Monopar Therapeutics (Nasdaq: MNPR) announced that CEO Chandler D. Robinson will present a corporate update at the H.C. Wainwright 22nd Annual Global Investment Conference, focusing on healthcare and biotech. The virtual conference is scheduled for September 16, 2020, at 1:30 PM EDT. Monopar is a clinical-stage biopharmaceutical company that develops therapeutics aimed at improving the life quality of cancer patients, with a pipeline including Validive, camsirubicin, and MNPR-101.