Monopar Therapeutics Inc Stock Price, News & Analysis

Monopar Therapeutics Inc. (Nasdaq: MNPR), a biopharmaceutical company focused on cancer therapeutics, announced upcoming presentations by CEO Chandler D. Robinson at several investor conferences in March. The presentations include:

• H.C. Wainwright Global Life Sciences Conference on March 9, 2021, at 7:00 a.m. ET.
• 33rd Annual Roth Conference on March 16, 2021, at 12:00 p.m. ET.
• Maxim’s 2021 Emerging Growth Virtual Conference on March 17, 2021, with the timing to be determined.

Monopar develops therapeutics aimed at improving cancer patients' lives.

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.