113 0 Kommentare Monopar Therapeutics Reports Third Quarter 2023 Financial Results and Recent Developments

MNPR-101 Radiopharma Program to Enter First-in-Human Studies Potentially As Early As December of This Year Camsirubicin Phase 1b Trial Efficacy and Safety Data Highlighted at the 2023 CTOS Annual Meeting

WILMETTE, Ill., Nov. 09, 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 third quarter 2023 financial results and summarized recent developments.

Recent Developments

MNPR-101 for Radiopharmaceutical Use – First-in-Human Study to Start Potentially As Early As December of This Year

Monopar continues to advance its MNPR-101 radiopharmaceutical program towards a first-in-human study in patients with advanced solid tumors. MNPR‐101 is a highly selective antibody against uPAR, a promising target overexpressed in multiple solid tumors, being developed as a precision radiopharmaceutical for both imaging and treatment of cancer. Much of the work with MNPR-101 is being done in collaboration with NorthStar Medical Radioisotopes LLC.

Preclinical data with MNPR-101 labeled with zirconium-89 (imaging radioisotope) as well as actinium-225 (a powerful alpha-emitting therapeutic radioisotope) so far have shown selective, high, and durable tumor uptake across multiple aggressive cancers including pancreatic, colorectal, and triple negative breast cancers. In addition, a strong, dose-dependent anti-tumor effect has been seen in in vivo pancreatic and triple-negative breast cancer models with favorable biodistribution profiles.

Camsirubicin – Phase 1b Dose-Escalation Trial, Treating Fifth Dose-Level Cohort (650 mg/m²)

The Phase 1b open-label, dose-escalating clinical trial of camsirubicin in patients with advanced soft tissue sarcoma (ASTS) is in the fifth dose-level cohort (650 mg/m²), which is nearly 2.5x the highest dose evaluated in any prior camsirubicin clinical trial (265 mg/m²). We have dosed to date two patients in the fifth dose cohort, and both experienced tumor size reductions, one of approximately 18% and the other of approximately 20%.

At the 2023 Connective Tissue Oncology Society (CTOS) Annual Meeting, Monopar presented Phase 1b clinical trial results to-date. So far, 9 out of the 14 enrolled ASTS patients have had stable disease (SD, as defined by RECIST 1.1 criteria) after camsirubicin treatment, including all patients in the fourth and fifth dose cohorts. No dose-limiting toxicity, as defined in the protocol, has been observed to-date. A medically complex patient in the fifth dose cohort has an ongoing left ventricular ejection fraction ("LVEF") decrease and is being assessed for potential anthracycline (camsirubicin) induced cardiotoxicity. This patient has a BMI of 42.5, one kidney, hypertension, a long-standing heart murmur, and a maternal history of heart failure.