MNPR-101-Lu / Monopar Therapeutics - LARVOL DELTA

MNPR‐101 for Radiopharmaceutical Use (GlobeNewswire) - "On September 26, 2025, Monopar received FDA clearance on its IND application for MNPR-101-Lu, which covers the protocol titled 'Phase 1, Open-Label, Multicenter, Dosimetry and Dose-Escalation Trial to Characterize the Safety, Tolerability, and Anti-Tumor Activity of Fractionated MNPR-101-Lu Dosing in the Treatment of uPAR-Expressing Advanced or Metastatic Solid Tumors'."

IND • New P1 trial • Solid Tumor

Monopar and EDNOC Announce Expanded Access Program for MNPR-101-Zr and MNPR-101-Lu in Advanced Cancers (The Manila Times) - "Monopar Therapeutics Inc...announced that the physician-sponsored Expanded Access Program ('EAP') for the investigational imaging agent MNPR-101-Zr and investigational therapeutic agent MNPR-101-Lu has received authorization to proceed from the U.S. Food and Drug Administration ('FDA'). The MNPR-101 EAP is now open for enrollment to patients with advanced solid tumors at EDNOC in Houston, Texas."

Trial status • Oncology • Solid Tumor

Monopar Announces First Patient Dosed with its Novel Therapeutic Radiopharmaceutical MNPR-101-Lu (GlobeNewswire) - "The MNPR-101-Lu intravenous infusion was well-tolerated with no serious adverse reactions reported. This patient, dosed under a compassionate use protocol in the US, has metastatic pancreatic cancer, and prior to dosing, the cancer was imaged using MNPR-101-Zr (a zirconium-89 imaging radioisotope conjugated to MNPR-101) with a PET/CT scanner and showed uPAR expression."

Trial status • Pancreatic Cancer

Results for the Third Quarter Ended September 30, 2024 Compared to the Third Quarter Ended September 30, 2023 (GlobeNewswire) - "Cash and cash equivalents as of September 30, 2024, were $6.0 million...Monopar projects that its current funds will be sufficient to continue operations at least into the first half of 2026...continue to conduct and conclude its first-in-human imaging and dosimetry Phase 1 clinical trial with MNPR-101-Zr; (3) continue to conduct its first-in-human therapeutic radiopharma clinical trial with MNPR-101-Lu; (4) advance its preclinical MNPR-101-Ac program into the clinic, and (5) invest in internal R&D projects to expand its radiopharma pipeline...R&D expenses for the three months ended September 30, 2024 were $984,000, compared to $1,317,000 for the three months ended September 30, 2023....These decreases were partially offset by a net increase of $186,000 due to other R&D expenses attributable to MNPR-101 for radiopharmaceutical use."

Commercial • Oncology • Solid Tumor

Monopar Presents Encouraging Human Clinical Dosimetry Data on its uPAR Program at EANM 2024 (GlobeNewswire) - "Monopar Therapeutics Inc...is presenting today data from the clinical and preclinical development of its novel first-in-class lead radiopharma program based on MNPR-101 at the European Association of Nuclear Medicine (EANM) 2024 Annual Congress held in Hamburg, Germany....Monopar’s presentation, accepted as a 'Top-Rated Oral Presentation' within the Scientific Program, illustrates the potential of the urokinase plasminogen activator receptor (uPAR) as a promising radiopharma target in solid tumors. Preclinical and clinical data show favorable biodistribution, tumor uptake, and low off-target binding of Monopar’s uPAR-targeted radiopharmaceuticals MNPR-101-Zr and MNPR-101-Lu."

Clinical data • Preclinical • Oncology • Solid Tumor

Monopar Initiates Clinical Trial of Novel uPAR-Targeted Radiopharmaceutical Therapy in Advanced Cancers (GlobeNewswire) - "Monopar Therapeutics Inc...announced that the Phase 1a clinical trial for its novel therapeutic radiopharmaceutical MNPR-101-Lu (MNPR-101 conjugated to lutetium-177) is now active and recruiting patients with advanced cancers....The first clinical trial site activated for the study is the Melbourne Theranostic Innovation Centre (MTIC) in Australia. To help identify those patients most likely to benefit from MNPR-101-Lu, the trial will only be open to those participating in the ongoing MNPR-101-Zr Phase 1 imaging and dosimetry clinical trial."

Trial status • Oncology • Solid Tumor

Monopar Receives Clearance to Proceed with Phase 1 Therapeutic Trial of Novel Radiopharmaceutical in Advanced Cancers (GlobeNewswire) - "Monopar Therapeutics Inc...announced it has received Human Research Ethics Committee (HREC) clearance in Australia to commence a Phase 1 therapeutic trial of its novel radiopharmaceutical MNPR-101-Lu....In a 90-day efficacy study in a human pancreatic cancer xenograft mouse model...MNPR-101-Lu demonstrated durable antitumor effects after a single injection, achieving complete elimination of tumors that lasted the duration of the study."

New P1 trial • Preclinical • Gastrointestinal Cancer • Oncology • Pancreatic Cancer • Solid Tumor