Monopar Therapeutics Inc Stock Price, News & Analysis

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.

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.