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 Results
MNPR-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 advancing toward first-in-human (FIH) studies potentially as early as the end of this year.