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Monopar Therapeutics Inc. (Nasdaq: MNPR) is a clinical-stage biopharmaceutical company focused on developing proprietary therapeutics aimed at prolonging life and enhancing the quality of life for cancer patients. Founded in 2014 and headquartered in Wilmette, Illinois, the company has made significant strides in the oncology sector with a robust pipeline of innovative treatments.
Monopar's leading candidate, Validive®, is a clonidine mucobuccal tablet currently in Phase III clinical trials. It aims to treat severe oral mucositis in patients undergoing radiation therapy for oropharyngeal cancer. Another key product, camsirubicin, is a next-generation analog of doxorubicin designed to limit cardiotoxicity while retaining its anticancer efficacy. This compound is presently in a Phase 1b dose-escalation trial for soft tissue sarcoma.
Additionally, Monopar is developing MNPR-101, a humanized monoclonal antibody targeting the urokinase plasminogen activator receptor (uPAR) for the treatment of advanced solid tumors and severe COVID-19. The company's MNPR-101-Zr is currently enrolling patients in a Phase 1 dosimetry clinical trial to evaluate its safety and biodistribution in various advanced cancers.
Monopar has established strategic partnerships to bolster its research and development efforts. The collaboration with Grupo Español de Investigación en Sarcomas is pivotal for advancing camsirubicin, while the partnership with NorthStar Medical Radioisotopes focuses on developing radio-immuno-therapeutics, including the supply of actinium-225 (Ac-225) for MNPR-101.
Financially, Monopar reported significant progress in reducing net loss from $10.5 million in 2022 to $8.4 million in 2023. The company ended 2023 with $7.3 million in cash and additional funding of $3.2 million expected in Q1 2024. These resources are projected to sustain operations through June 2025, enabling Monopar to reach key clinical milestones.
For more information on Monopar Therapeutics and their groundbreaking work in oncology, visit www.monopartx.com.
Monopar Therapeutics Inc. (Nasdaq: MNPR) announced significant updates regarding its clinical trials. The Validive Phase 2b/3 VOICE trial is now active at 43 sites in the US and EU, focusing on preventing severe oral mucositis (SOM) in oropharyngeal cancer patients undergoing chemoradiotherapy. Additionally, early signs of clinical benefit were observed in the open-label Phase 1b trial for camsirubicin, aimed at treating advanced soft tissue sarcoma. The company is also advancing its radiopharmaceutical platform and MNPR-202 in preclinical studies.
Monopar Therapeutics Inc. (Nasdaq: MNPR), a biopharmaceutical company focused on cancer therapeutics, announced that CEO Chandler Robinson, MD, will present at the H.C. Wainwright BioConnect Conference. The presentation will be available for on-demand viewing starting January 10, 2022, at 7:00am ET.
Monopar's pipeline includes Validive® for severe oral mucositis in oropharyngeal cancer, camsirubicin for advanced soft tissue sarcoma, and other promising candidates targeting advanced cancers and COVID-19.
Monopar Therapeutics (MNPR) has received a positive recommendation from its safety review committee to escalate to the second dose level in the camsirubicin Phase 1b trial for advanced soft tissue sarcoma. This decision follows safety data review from the initial dose cohort, allowing the evaluation of a higher dose of camsirubicin.
Camsirubicin, an analog of doxorubicin, has shown potential anti-tumor activity without the severe cardiotoxicity common to doxorubicin. The trial is actively enrolling patients, with results expected to enhance treatment options for cancer patients.
Monopar Therapeutics (Nasdaq: MNPR) reported its Q3 2021 results, highlighting advancements in clinical trials. Validive, aimed at preventing severe oral mucositis, has received clearance in Europe for Phase 2b/3 trials, set to reach interim results in H1 2022. The Camsirubicin Phase 1b trial has initiated dosing, with further site activations planned. As of September 30, 2021, cash and equivalents totaled $22.3 million, expected to fund ongoing trials through December 2022. However, the net loss increased to $2.5 million from $1.6 million year-over-year.
Monopar Therapeutics Inc. (MNPR) has announced the dosing of its first patient in a Phase 1b clinical trial for camsirubicin, targeting advanced soft tissue sarcoma (ASTS). This marks a significant milestone shortly after receiving FDA approval in August 2021. The trial aims to enroll 21 patients, addressing a critical need as ASTS patients typically face a life expectancy of 12-15 months. Camsirubicin, a novel analog of doxorubicin, has previously shown promising results without the severe cardiotoxicity associated with its predecessor. Further details can be found on ClinicalTrials.gov under identifier NCT 05043649.
Monopar Therapeutics (Nasdaq: MNPR) has initiated a Phase 1b clinical trial for camsirubicin, targeting advanced soft tissue sarcoma (ASTS). This open-label study aims to assess the safety and anti-tumor efficacy of escalating doses of camsirubicin with growth factor support. Previous studies showed camsirubicin's comparable anti-tumor activity to doxorubicin without causing irreversible heart damage. The trial enrollment has been expedited due to significant interest from clinical sites, marking a critical step in the drug's development.
Monopar Therapeutics (MNPR) has received authorization to proceed with the Phase 2b/3 VOICE clinical trial in France, targeting severe oral mucositis in oropharyngeal cancer patients undergoing chemoradiotherapy. This follows the trial's initiation in the US and is positioned to expand into other European countries shortly. The upcoming ESMO Congress will feature a presentation detailing the trial's design and rationale. The company anticipates reaching the interim results by early 2022. Validive, the treatment under evaluation, has shown promising Phase 2 results, reducing mucositis incidence significantly.
Monopar Therapeutics Inc. (Nasdaq: MNPR) announced that its CEO, Chandler D. Robinson, will present an overview of the company at two upcoming investor conferences in September 2021. The first presentation will be at the H.C. Wainwright 23rd Annual Global Investment Conference on September 13, 2021, at 7:00 a.m. ET. The second will occur at the Cantor Virtual Global Healthcare Conference 2021 on September 30, 2021, at 11:20 a.m. ET. Monopar focuses on developing therapeutics aimed at extending life and improving the quality of life for cancer patients.
Monopar Therapeutics (MNPR) announced its Q2 2021 financial results and key business advancements. The Phase 2b/3 VOICE trial of Validive has activated 20 sites and is expected to reach interim analysis in H1 2022. The FDA cleared the Phase 1b trial for camsirubicin in soft tissue sarcoma, with patient dosing anticipated in Q4 2021. The company also established a collaboration with the Cancer Science Institute of Singapore for MNPR-202 research. As of June 30, 2021, cash stood at $24.3 million, supporting operations through September 2022.
Monopar Therapeutics (Nasdaq: MNPR) announced the activation of 20 clinical trial sites for the Phase 2b portion of the Validive VOICE trial, aimed at preventing severe oral mucositis in oropharyngeal cancer patients. This milestone reflects higher-than-expected site enrollment rates. The company plans to expand the trial to additional sites and countries due to strong interest. An interim analysis of the trial is anticipated in the first half of 2022. Validive is a self-administered tablet addressing a significant patient need, impacting the lives of over 40,000 U.S. patients annually.
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