Monopar Therapeutics Inc. - MNPR STOCK NEWS

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.

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.