Press release
Monopar Therapeutics Reports Second Quarter 2023 Financial Results and Recent Developments
Camsirubicin Phase 1b Trial Currently at 5th Dose-Level (650 mg/m2), Generating Encouraging ResultsMNPR-101 Radiopharma Program Advancing Toward
About this update from Monopar Therapeutics Inc.
[{"type":"text","content":"Camsirubicin Phase 1b Trial Currently at 5th Dose-Level (650 mg/m2), Generating Encouraging ResultsMNPR-101 Radiopharma Program Advancing Toward First-in-Human Studies WILMETTE, Ill., Aug. 10, 2023 (GLOBE NEWSWIRE) -- Monopar Therapeutics Inc. (Monopar or the Company) (Nasdaq: MNPR), a clinical-stage biopharmaceutical company focused on developing innovative treatments for cancer patients, today announced second quarter 2023 financial results and summarized recent developments. Recent Developments Camsirubicin – Phase 1b Dose-Escalation Trial, Treating Fifth Dose-Level Cohort (650 mg/m2) As recently reported, both of the advanced soft tissue sarcoma (ASTS) patients so far in the fifth dose-level cohort (650 mg/m2) have experienced tumor size reductions – of 18% and 20%, respectively – after the first two cycles of camsirubicin treatment. These patients are set to receive additional cycles of camsirubicin treatment, which may result in further tumor size reduction. Phase 1b clinical trial data continue to support Monopar’s dose-response hypothesis with camsirubicin. The best response seen prior to the current 650 mg/m2 dose level was a 21% reduction in tumor size in a patient after receiving six cycles of camsirubicin treatment at the immediately prior dose level (520 mg/m2). This patient’s cancer was unresectable at study entry, but after the tumor size reduction, the patient was able to undergo a successful surgical removal of the cancer with clear margins. All three patients at this prior dose level (520 mg/m2) achieved stable disease with either a net reduction or no overall change in tumor size per RECIST 1.1 while on study drug. No drug-related cardiotoxicity has been observed in the trial to date as evaluated by the industry standard left ventricular ejection fraction (LVEF). This compares favorably to the well-documented cumulative dose-restricting cardiotoxicity experienced with doxorubicin, the current first-line treatment for ASTS. MNPR101 for Radiopharmaceutical Use – Promising Preclinical Studies Support First in Human Study MNPR-101 is a uPAR-targeting antibody being developed in collaboration with NorthStar Medical Radioisotopes LLC as a precision radiopharmaceutical for both imaging and treatment of cancer. Both the imaging and therapeutic agents are showing promise in preclinical studies and are advanci...