Tetrathiomolybdate

Monopar Therapeutics and EDNOC have received FDA authorization for an expanded access program providing MNPR-101-Zr imaging agent and MNPR-101-Lu therapeutic agent to patients with advanced solid tumors.

• Monopar Therapeutics presented late-breaker data at EASL 2025 showing sustained clinical improvements in Wilson disease patients treated with ALXN1840 (tiomolybdate choline) over a median treatment duration of 2.63 years. • The pooled analysis from multiple clinical trials (n=255) demonstrated improvements in patient-reported symptoms, copper mobilization, and clinical assessments, with fewer than 5% of patients experiencing drug-related serious adverse events. • Patients reported higher convenience and effectiveness with ALXN1840 compared to standard of care, suggesting the drug candidate could provide meaningful benefits for the management of this rare genetic condition.

Monopar Therapeutics in-licensed ALXN-1840 from Alexion for Wilson disease, planning regulatory discussions with the FDA focusing on patients with severe symptoms.

Monopar Therapeutics has acquired ALXN-1840, a late-stage drug candidate for Wilson disease, from Alexion, AstraZeneca Rare Disease, taking over global development and commercialization.

• Monopar Therapeutics has obtained an exclusive worldwide license from Alexion for ALXN-1840, a Wilson disease drug candidate that has completed Phase 3 trials. • The agreement includes an upfront payment of cash and Monopar equity, along with future tiered royalties and milestone payments for Alexion. • ALXN-1840 demonstrated significant copper mobilization in Phase 3 trials, with generally mild to moderate adverse events and no neurological worsening observed. • Monopar plans to oversee all future global development and commercialization of ALXN-1840, building on substantial clinical data already generated by Alexion.