MNPR 101 / Monopar Therapeutics, Xoma - LARVOL DELTA

MNPR-101-DFO*-89Zr Expanded Access Program (EAP) for Patients With Solid Tumor Cancer (clinicaltrials.gov) - P=N/A | N=0 | Available | Sponsor: Monopar Therapeutics

New trial • Oncology • Solid Tumor

MNPR-101-PCTA-177Lu Expanded Access Program (EAP) for Patients With Solid Tumor Cancer (clinicaltrials.gov) - P=N/A | N=0 | Available | Sponsor: Monopar Therapeutics

New trial • Oncology • Solid Tumor

MNPR101-Lu-1-01: Dose-Escalation of MNPR-101-PCTA-177Lu in Solid Tumors (clinicaltrials.gov) - P1 | N=12 | Recruiting | Sponsor: Monopar Therapeutics | Trial completion date: Jun 2025 ➔ Jan 2027 | Trial primary completion date: Jun 2025 ➔ Dec 2026

Trial completion date • Trial primary completion date • Bladder Cancer • Breast Cancer • Colorectal Cancer • Gastric Cancer • Genito-urinary Cancer • Lung Cancer • Oncology • Ovarian Cancer • Pancreatic Cancer • Solid Tumor • Triple Negative Breast Cancer • Urothelial Cancer

Monopar Expands Radiopharma Intellectual Property Portfolio with Patent Filing on New Compounds and Linkers (GlobeNewswire) - "Monopar Therapeutics Inc...announced the filing of a provisional patent covering new therapeutic radiopharmaceuticals based on a family of linkers used to connect radioisotopes with targeting agents, including Monopar’s uPAR targeting antibody MNPR-101. Highlights of the patent filing include: Composition of Matter: Claims cover a family of linkers, as well as Monopar’s uPAR targeting agents linked with these along with therapeutic radioisotopes; Stability and Biodistribution: These proprietary new linkers have been created to enhance the stability and biodistribution of Monopar’s array of therapeutic radiopharmaceuticals; Versatility: The newly developed linker family works with a wide range of isotopes and targeting molecules, including small molecules/peptides and antibodies."

Patent • Oncology

MNPR101-Lu-1-01: Dose-Escalation of MNPR-101-PCTA-177Lu in Solid Tumors (clinicaltrials.gov) - P1 | N=12 | Recruiting | Sponsor: Monopar Therapeutics | Not yet recruiting ➔ Recruiting

Enrollment open • Bladder Cancer • Breast Cancer • Colorectal Cancer • Gastric Cancer • Gastrointestinal Cancer • Genito-urinary Cancer • Hepatology • Lung Cancer • Oncology • Ovarian Cancer • Pancreatic Cancer • Solid Tumor • Triple Negative Breast Cancer • Urothelial Cancer

Dose-Escalation of MNPR-101-PCTA-177Lu in Solid Tumors (clinicaltrials.gov) - P1 | N=12 | Not yet recruiting | Sponsor: Monopar Therapeutics

New P1 trial • Bladder Cancer • Breast Cancer • Colorectal Cancer • Gastric Cancer • Gastrointestinal Cancer • Genito-urinary Cancer • Hepatology • Lung Cancer • Oncology • Ovarian Cancer • Pancreatic Cancer • Solid Tumor • Triple Negative Breast Cancer • Urothelial Cancer

Preclinical Evaluation of Anti-uPAR Antibody as a Radiolabeled PET Imaging Candidate in Solid Tumors (SNMMI 2024) - " MNPR-101 was conjugated to a bifunctional chelator, p-SCN-Bn-Deferoxamine (DFO) and radiolabeled with zirconium-89 (89Zr). This preclinical study supports the development of MNPR-101-DFO-89Zr as a radio-diagnostic in a first in human PET imaging study of uPAR expression in various cancers. It also serves as a basis for future therapeutic studies using an Actinium-225 (225Ac) or Lutetium-177 (177Lu) labeled version of MNPR-101. Overall, the data shows that MNPR-101 is a promising theranostic anti-cancer candidate for the treatment of triple-negative breast, pancreatic, and colorectal cancers."

Preclinical • Breast Cancer • Colorectal Cancer • Gastrointestinal Cancer • Hepatology • Oncology • Pancreatic Cancer • Solid Tumor • Triple Negative Breast Cancer

Monopar and NorthStar Amend & Extend Collaboration (GlobeNewswire) - "Monopar Therapeutics Inc...and NorthStar Medical Radioisotopes, LLC...announced an amendment and expansion to their existing collaboration. Under terms of the revised collaboration, the Companies entered into a long-term, non-exclusive master supply agreement for NorthStar to provide Monopar with the powerful therapeutic radioisotope actinium-225 (Ac-225)....Monopar has acquired those rights from NorthStar, together with certain broad, jointly developed intellectual property pertaining to MNPR-101, giving Monopar full ownership and title to its lead MNPR-101 radiopharmaceutical platform. Both companies will share ownership of the filed patent application on the use of PCTA as a linker with Ac-225, which has shown superior binding and yield with Ac-225 over the current industry-leading linker, DOTA."

Licensing / partnership • Oncology

Monopar Announces Filing of Patent Protecting MNPR-101 Radiopharma Optimization Findings (GlobeNewswire) - "Monopar Therapeutics Inc...announced that it has filed a provisional patent application pertaining to the recent advancements and optimizations Monopar has achieved with its MNPR-101 radiopharmaceutical program. The provisional patent titled 'Antibody Radioisotope Constructs' that was filed with the United States Patent and Trademark Office (USPTO) outlines the MNPR-101-Zr construct, including variations on the radioisotopes, linkers, and antibody which could enhance the clinical profile of the construct, including properties such as its stability and biodistribution....Monopar expects this provisional patent application to further strengthen its intellectual property around the MNPR-101 radiopharma program, under which the Company is aiming to develop therapies for numerous hard-to-treat advanced cancers that express uPAR."

Patent • Oncology • Solid Tumor

Monopar Announces Promising Preclinical Data for its MNPR-101 Radiopharma Program Targeting Advanced Cancers (GlobeNewswire) - "Monopar Therapeutics...announced promising preclinical imaging and therapeutic efficacy data for its MNPR-101 radiopharmaceutical program. This novel first-in-class radiopharma program targets cancers expressing the urokinase plasminogen activator receptor (uPAR), which include a majority of all triple-negative breast, colorectal, and pancreatic cancers."

Preclinical • Colorectal Cancer • Pancreatic Cancer • Triple Negative Breast Cancer

Monopar Therapeutics Reports Third Quarter 2023 Financial Results and Recent Developments (GlobeNewswire) - "MNPR-101 for Radiopharmaceutical Use – first-in-human study to start potentially as early as aecember 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."

New P1 trial • Oncology • Solid Tumor

Monopar Announces MNPR-101 Radiopharma Collaboration Agreement with National University of Singapore (GlobeNewswire) - "Monopar Therapeutics Inc...announced a collaboration with the Cancer Science Institute of Singapore (CSI Singapore) at the National University of Singapore (NUS) to evaluate radiopharmaceutical versions of MNPR-101 in several aggressive cancers. MNPR-101 is a novel, first-in-class humanized monoclonal antibody to the urokinase Plasminogen Activator Receptor (uPAR)....In this collaboration, Dr. Jeyasekharan will initially investigate uPAR expression levels in tissue samples from patients with various subtypes of advanced soft tissue sarcoma (ASTS)."

Licensing / partnership • Oncology • Sarcoma • Soft Tissue Sarcoma • Solid Tumor

Side-by-Side Comparison of uPAR-Targeting Optical Imaging Antibodies and Antibody Fragments for Fluorescence-Guided Surgery of Solid Tumors. (PubMed, Mol Imaging Biol) - "In a side-by-side comparison, FGS with uPAR-targeting antibody fragments compared with the parent IgG resulted in earlier tumor visualization at the expense of peak fluorescence intensity."

Journal • Colon Cancer • Colorectal Cancer • Gastrointestinal Cancer • Head and Neck Cancer • Hepatology • Infectious Disease • Oncology • Oral Cancer • Otorhinolaryngology • Pancreatic Cancer • Pancreatic Ductal Adenocarcinoma • Peritoneal Cancer • Solid Tumor • Squamous Cell Carcinoma • Squamous Cell Carcinoma of Head and Neck

Monopar and NorthStar Announce Filing of Composition of Matter Patent Protecting MNPR-101 Radiotherapeutic (GlobeNewswire) - "Monopar Therapeutics Inc...and NorthStar Medical Radioisotopes, LLC...announced the filing of a provisional composition of matter patent titled 'Urokinase Plasminogen Activator Receptor-Targeted Radiopharmaceutical' covering a radiotherapeutic consisting of Monopar’s proprietary antibody MNPR-101 bound to Actinium-225 (Ac-225) via the metal binding agent PCTA. This Radio-Immuno-Therapeutic (RIT) demonstrated a 98% radiochemical purity and has the potential to be a highly selective, potent treatment for a variety of cancers, severe COVID-19, and other diseases characterized by aberrant urokinase plasminogen activator receptor (uPAR) expression."

Patent • Novel Coronavirus Disease • Oncology

uPAR antibody (huATN-658) and Zometa reduce breast cancer growth and skeletal lesions. (PubMed, Bone Res) - "Transcriptome analysis revealed that combination treatment significantly changes the expression of genes from signaling pathways implicated in tumor progression and bone remodeling. Results from these studies provide a rationale for the continued development of huATN-658 as a monotherapy and in combination with currently approved agents such as Zometa in patients with metastatic breast cancer."

Journal • Breast Cancer • Oncology • Solid Tumor

Monopar Partners with Seasoned Medtech Executive to Explore the Potential of MNPR-101 as a uPAR Imaging Agent in Cancer Surgery (GlobeNewswire) - "Monopar Therapeutics Inc...today announced it has entered into an agreement with serial medtech entrepreneur, Andrew Cittadine, to explore over the next few months strategic and developmental options for MNPR-101 as an intraoperative imaging agent in bladder cancer surgery as well as other cancers."

Licensing / partnership • Bladder Cancer • Genito-urinary Cancer • Oncology • Urothelial Cancer

A multimodal molecular imaging approach targeting urokinase plasminogen activator receptor for the diagnosis, resection and surveillance of urothelial cell carcinoma. (PubMed, Eur J Cancer) - "MNPR-101-IRDye800CW is suitable for multimodal imaging of UCC, awaiting clinical translation."

Journal • Bladder Cancer • Genito-urinary Cancer • Oncology • Solid Tumor • Urothelial Cancer • EPCAM

Monopar Announces Issuance of Patent Covering Composition of Matter for MNPR-101 in Canada (GlobeNewswire) - “Monopar Therapeutics Inc…announced the issuance of a patent covering composition of matter for MNPR-101 in Canada, adding to its existing protection in key markets around the world including the US, Europe and Japan.”

Patent • Oncology

Monopar Announces Publication Demonstrating Potential Utility of MNPR-101 as an Imaging Agent to Improve Surgical Outcomes in Bladder Cancer (GlobeNewswire) - "Monopar Therapeutics Inc...announced the publication of a peer-reviewed study in the European Journal of Cancer which shows the potential utility of MNPR-101 as a uPAR imaging agent to improve surgical outcomes in bladder cancer....The publication reports that high expression of uPAR in bladder cancer is localized at the tumor periphery, suggesting that using a fluorescent-conjugated MNPR-101 probe might allow surgeons to better visualize the borders of the tumor, potentially resulting in more complete tumor resection and thereby minimizing relapse. Similar approaches have been utilized successfully in the resection of other tumor types, such as breast cancer."

Preclinical • Bladder Cancer • Breast Cancer • Genito-urinary Cancer • Oncology