Monopar Therapeutics, a clinical-stage biopharmaceutical company dedicated to advancing proprietary therapeutics aimed at enhancing the longevity and quality of life for cancer patients, is set to unveil data from its ongoing Phase 1b open-label, dose-escalating clinical trial of camsirubicin in patients with advanced soft tissue sarcoma (ASTS). This revelation will take place later today at the 2023 Connective Tissue Oncology Society (CTOS) Annual Meeting, which has brought together the foremost sarcoma specialists from around the globe. In anticipation of this significant announcement, the stock of Monopar Therapeutics has witnessed a notable surge in value today.
At the time of this publication, Monopar Therapeutics Inc stock (MNPR) has witnessed a surge.
Monopar Therapeutics Inc
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For those interested, Monopar’s detailed poster presentation is accessible via the following link: https://www.monopartx.com/pipeline/Camsirubicin/mnpr-201-001-clinical-trial.
The Phase 1b clinical trial has successfully enrolled 14 ASTS patients, comprising 9 females and 5 males, with ages spanning from 26 to 81 years (median = 52.5 years). These participants are distributed across five dose cohorts. At present, the trial is in progress and has reached the fifth dose level cohort, which involves an administered dosage of 650 mg/m2.
To date, 9 out of the 14 patients have demonstrated stable disease (SD), a designation in accordance with the RECIST 1.1 criteria, subsequent to receiving camsirubicin treatment. Notably, all patients in the fourth and fifth cohorts achieved stable disease. Among these, the three most recently treated patients experienced an approximate 20% reduction in tumor size during their latest study scan. Of particular significance is one patient who initially presented with unresectable cancer. Following the substantial reduction in tumor size, this patient became eligible for resection and subsequently underwent a successful surgical removal of the cancer, achieving clear margins.
Up to this point, there have been no instances of dose-limiting toxicity, as outlined in the trial protocol. However, a medically complex patient within the 650 mg/m2 dose cohort is being closely monitored due to an ongoing decrease in left ventricular ejection fraction (LVEF). This patient possesses a BMI of 42.5, only one functioning kidney, a history of hypertension, a longstanding heart murmur, and a maternal history of heart failure. It is worth noting that there have been no reported toxicities necessitating an expansion of any dose cohort, and as of now, the maximum tolerated dose (MTD) has not yet been determined.