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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) received a positive recommendation from its safety review committee to advance to the fifth dose level (650 mg/m2) in its camsirubicin Phase 1b trial for advanced soft tissue sarcoma (ASTS). This decision follows safety reviews from prior doses, indicating the drug's favorable safety profile compared to doxorubicin. The trial aims to improve progression-free survival, showing promise based on earlier studies. Camsirubicin, a novel analog of doxorubicin, has not shown the cardiotoxicity linked to the original drug in earlier trials, making it a significant advancement in treatment options for ASTS.
Monopar Therapeutics Inc. (Nasdaq: MNPR) announced promising preclinical data for its drug candidate MNPR-202, developed in collaboration with the Cancer Science Institute of Singapore. MNPR-202, a DNA Damaging Response drug akin to doxorubicin, demonstrates comparable cytotoxic potency while evading resistance in certain tumors. The findings, showcased at the ASH Annual Meeting, suggest that MNPR-202 may enhance immune activation and offer superior results in combination regimens. This positions MNPR-202 as a potential disruptor in the chemotherapy landscape for various cancers.
Monopar Therapeutics (MNPR) announced promising results from its ongoing Phase 1b trial of camsirubicin for advanced soft tissue sarcoma, presented at the CTOS Annual Meeting. The trial has enrolled 11 patients, with 5 of 10 showing stable disease at 12 weeks. Camsirubicin aims to enhance efficacy while minimizing cardiac damage compared to doxorubicin, the current standard. The trial is currently escalating doses, with no drug-related cardiotoxicity observed so far, emphasizing its potential for improved patient outcomes.
Monopar Therapeutics (MNPR) reported its Q3 2022 financial results, revealing cash reserves of $14.3 million, which will fund ongoing clinical trials through at least November 2023. The VOICE trial for Validive is on track with its Phase 2b/3 interim analysis scheduled for Q1 2023. Meanwhile, early data from the Camsirubicin trial will be presented at CTOS 2022. The company’s Q3 net loss was $2.4 million ($0.19 per share), with a slight decrease in R&D expenses but an increase in G&A expenses. Monopar plans to seek additional funding within the next year.
Monopar Therapeutics Inc. (Nasdaq: MNPR) announced plans to present clinical data on camsirubicin and preclinical data on MNPR-202 in the upcoming months. Key events include the presentation of camsirubicin Phase 1b data at the CTOS Annual Meeting from November 16-19, 2022, in Vancouver, and preclinical data on MNPR-202 at the ASH Annual Meeting from December 10-13, 2022, in New Orleans. Additionally, the company will report its interim analysis for the Validive Phase 2b/3 VOICE trial in Q1 2023, with ongoing patient enrollment at 71 sites.
Monopar Therapeutics Inc. (Nasdaq: MNPR) announced that its drug candidate MNPR-202 will be presented at the 64th ASH Annual Meeting & Exposition in New Orleans. This presentation marks the initial data release from the collaboration with Dr. Anand Jeyasekharan, focusing on MNPR-202's effects on DNA damage response in cancer cells. Designed for potential use against cancers resistant to doxorubicin, MNPR-202 aims to enhance therapeutic options. CEO Chandler Robinson expressed optimism about the collaboration's progress and the anticipated findings.
Monopar Therapeutics (MNPR) has announced that its abstract on camsirubicin will be presented at the 2022 Connective Tissue Oncology Society Annual Meeting in Vancouver, Canada, from November 16-19, 2022. This presentation will reveal data from a Phase 1b clinical trial of camsirubicin in advanced soft tissue sarcoma patients, marking the first formal release of this data. The conference gathers leading sarcoma specialists globally, and Monopar aims to share insights derived from its dose-escalation study.
Monopar Therapeutics (Nasdaq: MNPR) has provided an update on its Validive Phase 2b/3 VOICE clinical trial aimed at preventing severe oral mucositis in patients undergoing chemoradiotherapy for oropharyngeal cancer. The company has enrolled over 130 patients, completed the Phase 2b enrollment, and activated 68 sites, including expansions into Germany and Poland. An interim analysis of the Phase 2b data will guide further enrollment in Phase 3, expected to yield results in Q1 2023.
Monopar Therapeutics (Nasdaq: MNPR), a clinical-stage biopharmaceutical company, announced its CEO, Chandler Robinson, will present at the Roth Inaugural Healthcare Opportunities Conference on October 6, 2022, at 12:00 p.m. (ET). The conference will be held at The Yale Club, New York City.
Monopar focuses on developing therapeutics aimed at improving the quality of life for cancer patients, with a pipeline that includes Validive® and camsirubicin for different cancer treatments. For more information, visit www.monopartx.com.
Monopar Therapeutics (Nasdaq: MNPR) reported second quarter 2022 results, announcing ongoing advancements in their clinical programs. They are actively recruiting for the Validive Phase 2b/3 VOICE trial, now with 58 sites, with an interim analysis expected in Q1 2023. The Camsirubicin trial has progressed to the fourth dose level, showing early clinical benefits. Cash reserves of $16.5 million will fund operations through September 2023, while a net loss of $2.8 million was reported for the quarter. The company aims to secure additional funding for future developments.
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