Monopar Therapeutics Reports Third Quarter 2024 Financial Results and Recent Developments
In-licensed ALXN-1840 (a Late-Stage Wilson Disease Drug Candidate) from Alexion, AstraZeneca Rare DiseaseTwo Novel Radiopharma Clinical Trials now Active and Enrolling Patients with Advanced Solid Cancers
WILMETTE, Ill., Nov. 08, 2024 (GLOBE NEWSWIRE) -- Monopar Therapeutics Inc. ("Monopar" or the "Company") (NASDAQ:MNPR), a clinical-stage biotechnology company focused on developing innovative treatments for patients with unmet medical needs, today announced third quarter 2024 financial results and summarized recent developments.
Recent Developments
ALXN-1840 for Wilson disease, Late Stage
On October 23, 2024, the Company entered into an exclusive license with Alexion, AstraZeneca Rare Disease whereby the Company gained worldwide rights to develop and commercialize ALXN-1840 (bis-choline tetrathiomolybdate). ALXN-1840 is a drug candidate for Wilson disease that is in late-stage development, having already completed a Phase 3 clinical trial. Monopar will be assembling a regulatory package and initiating discussions with the FDA, with an initial focus on Wilson disease patients with more severe symptoms. More details on this transaction can be found here (link).
MNPR-101 for Radiopharmaceutical Use, Phase 1
In August 2024, the Company received regulatory clearance in Australia to commence a first-in-human Phase 1a therapeutic clinical trial of its novel urokinase plasminogen activator receptor (uPAR)-targeted radiopharmaceutical therapy MNPR-101-Lu (MNPR-101 conjugated to lutetium-177) in patients with advanced solid cancers. The Company activated its first clinical trial site and launched the study in October 2024; the trial is currently active and recruiting patients.
In September 2024, the Company announced positive early clinical data from its ongoing open-label Phase 1 imaging and dosimetry clinical trial of MNPR-101-Zr that validate the tumor-targeting ability of MNPR-101-Zr. In October, the Company presented additional clinical data at the European Association of Nuclear Medicine Annual Congress 2024. The data demonstrate clear and durable tumor uptake of MNPR-101-Zr in a patient with advanced ovarian cancer and show favorable biodistribution with low off-target binding.
The Company is also actively exploring opportunities to expand its radiopharmaceutical pipeline primarily through internal development efforts. In October 2024, the Company announced the filing of a provisional patent application for new radiopharmaceutical compounds and a family of linkers used to connect radioisotopes with targeting agents, including its uPAR-targeting antibody MNPR-101. This provisional patent could enable the Company to use these linkers to create new proprietary radiopharmaceuticals to pursue well-established, high-value cancer targets of interest.
Capital Raise
On October 30, 2024, the Company completed a registered ...