Monopar Therapeutics Launches FDA-Authorized Expanded Access Program for uPAR-Targeted Radiopharmaceuticals in Advanced Cancers
核心洞察
Monopar Therapeutics and EDNOC (搜索) 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 (搜索).
The program targets aggressive cancers including triple-negative breast, pancreatic, and colorectal cancers through selective targeting of the urokinase plasminogen activator receptor (搜索) (uPAR (搜索)).
EDNOC (搜索) in Houston, Texas serves as the treatment center and is among the first private outpatient facilities designated as a Radiopharmaceutical Therapy Center of Excellence by SNMMI (搜索).
Monopar Therapeutics Inc. (Nasdaq: MNPR) and Excel Diagnostics and Nuclear Oncology Center (搜索) (EDNOC (搜索)) have announced FDA authorization for a physician-sponsored Expanded Access Program (EAP) providing investigational radiopharmaceuticals MNPR-101-Zr and MNPR-101-Lu to patients with advanced solid tumors (搜索).
The program is now open for enrollment at EDNOC (搜索) in Houston, Texas, where patients will be treated under the supervision of Ebrahim S. Delpassand, MD, founder and medical director of EDNOC. The facility is among the first private outpatient centers in the U.S. to receive designation as a Radiopharmaceutical Therapy Center of Excellence by the Society of Nuclear Medicine and Molecular Imaging (搜索) (SNMMI (搜索)).
Targeting Aggressive Cancer Types
"We are pleased to provide patients in the United States with access to MNPR-101-Zr and MNPR-101-Lu, which were developed to target aggressive cancers, such as triple-negative breast, pancreatic, and colorectal cancer (搜索)," said Andrew Cittadine, Chief Operating Officer of Monopar. The EAP represents continued progress following last year's initiation of Phase 1 clinical trials in Australia with both agents.
Dr. Delpassand emphasized the therapeutic potential, stating, "Targeting uPAR (搜索)-expressing solid tumors will be another promising frontier in radioligand therapy to help patients with 'difficult-to-treat' cancers."
Novel uPAR-Targeted Approach
MNPR-101 is Monopar's proprietary antibody targeting the urokinase plasminogen activator receptor (搜索) (uPAR (搜索)), which is expressed in numerous tumor types, including pancreatic, breast, colorectal, ovarian, and bladder cancers. The company aims to deliver targeted radiopharmaceutical therapy that kills cancer cells while minimizing damage to healthy tissue through selective uPAR targeting.
MNPR-101-Zr consists of MNPR-101 conjugated to zirconium-89 and is designed for imaging advanced cancers, while MNPR-101-Lu combines MNPR-101 with lutetium-177 as an investigational treatment for advanced solid cancers.
Expanded Access Program Details
The EAP serves as a pathway for patients with serious or immediately life-threatening conditions to access investigational medical products outside of clinical trials when no comparable or satisfactory alternative treatment is available. Healthcare providers and cancer patients interested in learning more about eligibility criteria can access information through ClinicalTrials.gov using identifiers NCT06980506 for the imaging EAP and NCT06980519 for the therapy EAP.
Company Pipeline Progress
Monopar Therapeutics is a clinical-stage biopharmaceutical company focused on advancing late-stage ALXN1840 for Wilson disease (搜索) alongside its radiopharmaceutical programs. The company's pipeline includes Phase 1-stage MNPR-101-Zr for imaging advanced cancers, Phase 1a-stage MNPR-101-Lu, and late preclinical-stage MNPR-101-Ac (搜索) for treating advanced cancers.
EDNOC (搜索) has been designated as a Radiopharmaceutical Therapy Center of Excellence by SNMMI (搜索) since 2020 and has pioneered bringing several new diagnostic and therapeutic radiopharmaceuticals to the United States for the first time.