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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 (Nasdaq: MNPR) announced FDA clearance to proceed with a Phase 1b trial for camsirubicin in patients with advanced soft tissue sarcoma. This open-label dose-escalation trial aims to explore the potential of camsirubicin, combined with growth factor support (pegfilgrastim), to extend dosing duration compared to doxorubicin. The Company expects to dose the first patient in Q4 2021. If successful, camsirubicin could be evaluated for 13 other cancer indications.
Monopar Therapeutics Inc. (Nasdaq: MNPR) appointed Dr. Octávio Costa as Chief Medical Officer, effective immediately. Dr. Costa brings over 30 years of experience in clinical development and regulatory affairs, previously serving in significant roles at Merck, Celgene, and Novartis. His expertise in navigating all clinical phases will be crucial as Monopar advances its pipeline, which includes innovative cancer therapies. CEO Chandler Robinson expressed confidence in Dr. Costa’s ability to accelerate the company’s clinical efforts as they enter late-stage studies.
Monopar Therapeutics Inc. (Nasdaq: MNPR) announced the presentation of its oropharyngeal cancer (OPC) patient population analysis from the Phase 2 Validive trial at the MASCC/ISOO 2021 annual meeting. This analysis supports the design of the Phase 2b/3 VOICE trial, which is currently recruiting OPC patients in the US. Validive is aimed at preventing severe oral mucositis caused by chemoradiotherapy, with prior Phase 2 results showing a relative incidence reduction of 40% compared to placebo. The presentation will be available on demand beginning June 25, 2021.
Monopar Therapeutics Inc. (Nasdaq: MNPR) announced a collaboration with the Cancer Science Institute of Singapore to evaluate its new drug MNPR-202, designed to treat chemotherapy-resistant cancers. MNPR-202 maintains a potentially non-cardiotoxic structure similar to camsirubicin but is modified to target cancers that resist traditional therapies. This partnership aims to deepen the understanding of MNPR-202’s impact on cancer cells and its potential to enhance immunotherapy treatments. A clinical trial for camsirubicin is set to begin in late 2021.
Monopar Therapeutics Inc. (Nasdaq: MNPR) announced the appointment of Andrew Cittadine as Chief Operating Officer on June 1, 2021. Cittadine brings extensive experience in healthcare, having founded successful companies such as Sensant Corp. and American Biooptics. He will oversee Monopar's global operations and business strategy, contributing to their goal of developing therapeutics for cancer patients. Monopar's pipeline includes Validive, camsirubicin, and the preclinical antibody MNPR-101. CEO Chandler Robinson expressed confidence in Cittadine’s leadership during this pivotal time for the company.
Monopar Therapeutics (MNPR) and NorthStar Medical Radioisotopes have filed a provisional patent for a radiotherapeutic combining Monopar's MNPR-101 antibody with Actinium-225. The Radio-Immuno-Therapeutic (RIT) shows 98% radiochemical purity, indicating potential as an effective treatment for certain cancers and severe COVID-19.
This development may also allow for more efficient production with reduced material use, thus improving supply chain logistics. If granted, the patent could significantly enhance MNPR-101’s patent estate.
Monopar Therapeutics Inc. (MNPR) and NorthStar Medical Radioisotopes have filed a provisional patent for a new approach to improve the efficacy of Actinium-based radiopharmaceuticals. The patent focuses on using PCTA to enhance binding efficiency of Ac-225 to antibodies, showing nearly 100% binding compared to traditional methods. This innovation could lead to increased efficacy, reduced toxicity, and better manufacturing efficiency. The companies aim to explore development and licensing opportunities for this technology, which holds potential to address challenges in cancer treatment.
Monopar Therapeutics Inc. (Nasdaq: MNPR) announced key updates in their latest press release dated May 13, 2021. The company reported the first patient dosed in the Phase 2b/3 VOICE clinical trial for Validive, aimed at preventing severe oral mucositis in cancer patients. They also received patent allowances for Validive and a novel family of camsirubicin analogs. Financially, Monopar holds $25.7 million in cash, though net losses increased to $1.9 million in Q1 2021.
Monopar Therapeutics (Nasdaq: MNPR) announced the publication of a peer-reviewed study demonstrating the potential of its uPA antibody fragment for imaging triple-negative breast cancer. The study suggests that this technology could facilitate rapid PET imaging to identify and monitor uPA overexpression in tumors, which is crucial for treatment decisions. The company is optimistic about leveraging its panel of uPA-targeted antibodies for cancer imaging and treatment development.
Monopar Therapeutics (Nasdaq: MNPR) recently announced key developments and financial results for Q4 and full-year 2020. The company commenced the Phase 2b/3 VOICE clinical trial for Validive, aimed at preventing severe oral mucositis in oropharyngeal cancer patients. A Phase 2 trial for camsirubicin is set to begin in Q2 2021, evaluating its effectiveness against doxorubicin. The company reported a net loss of $6.3 million for 2020, showing an increase from $4.2 million in 2019, with cash reserves of $16.7 million to support operations at least through March 2022.
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