MNPR-101-Ac225 / Monopar Therapeutics, NorthStar Medical Radioisotopes - LARVOL DELTA

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

Evaluation of Anti-uPAR Antibody as a Radiopharmaceutical for Imaging and Treatment of Solid Tumors (EANM 2024) - "Efficacy data using 177Lu or 225Ac labeled MNPR-101 showed near complete elimination of established tumors after a single injection of the agents... These preclinical studies support the development of MNPR-101-89Zr as a radio-diagnostic and the recently initiated first-in-human PET imaging study 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 show that MNPR-101 is a promising theranostic anti-cancer candidate for cancer treatment."

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

Monopar Announces Positive Early Human Clinical Data Validating the Tumor Targeting Ability of MNPR-101-Zr (GlobeNewswire) - P1 | N=12 | NCT06337084 | Sponsor: Monopar Therapeutics | "A total-body positron emission tomography (PET) image was taken at 168 hours (7 days) post administration of MNPR-101-Zr (a zirconium-89 imaging radioisotope conjugated to MNPR-101) of the first cancer patient in the trial with one of the known high uPAR-expressing cancer types. The results....demonstrate the specificity, durability, and uptake of MNPR-101-Zr in the metastatic tumors relative to normal tissue. The regions of higher uptake also align with the locations of the previously observed metastatic tumors on conventional FDG PET imaging...We are looking forward to sharing additional data at the upcoming European Association of Nuclear Medicine 2024 Annual Congress to be held in Hamburg, Germany on October 19-23, 2024..."

P1 data • Oncology • Solid Tumor

Monopar Therapeutics Reports Second Quarter 2024 Financial Results and Recent Developments (GlobeNewswire) - "An open-label Phase 1 clinical trial for Monopar’s therapeutic radiopharmaceutical MNPR-101-RIT is on track to initiate as early as Q4 2024. Preclinical in vivo studies of therapeutic radioisotopes, such as actinium-225 and lutetium-177, bound to MNPR-101 have shown near complete elimination of uPAR-expressing tumors after just a single injection."

New P1 trial • Preclinical • Oncology

Monopar Announces MNPR-101-RIT Abstract Accepted as a Top-Rated Oral Presentation at EANM’24 (GlobeNewswire) - "Monopar Therapeutics Inc...announced that its abstract...as been accepted as a 'Top-Rated Oral Presentation' within the Scientific Program of the European Association of Nuclear Medicine (EANM) 2024 Annual Congress to be held on October 19-23, 2024 in Hamburg, Germany. Monopar’s abstract details its MNPR-101-RIT, a novel first-in-class radio-immuno-therapeutic program that targets cancers expressing the urokinase plasminogen activator receptor (uPAR), including triple-negative breast, colorectal, and pancreatic cancers. The Company’s preclinical data demonstrate compelling and durable anti-tumor benefits with MNPR-101 conjugated to therapeutic radioisotopes, including lutetium-177 (Lu-177) and actinium-225 (Ac-225)."

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

Monopar Therapeutics Reports First Quarter 2024 Financial Results and Strategic Focus on its Radiopharma Pipeline (GlobeNewswire) - "Announced that Monopar’s abstract on MNPR-101-Zr radiopharma program was selected for presentation at the Society of Nuclear Medicine and Molecular Imaging’s Annual Meeting on June 8-11, 2024; Monopar is targeting initiating a Phase 1 clinical study in advanced cancers with its therapeutic radiopharmaceutical MNPR-101-RIT as soon as the end of this year or early next year."

Clinical data • New P1 trial • Oncology • Solid Tumor

Monopar Announces Radiopharma Presentation Selected for Society of Nuclear Medicine and Molecular Imaging 2024 Annual Meeting (GlobeNewswire) - "Monopar Therapeutics Inc...today announced that its abstract on the preclinical data for its radiopharmaceutical program MNPR-101-Zr (MNPR-101 conjugated to zirconium-89) submitted to the Society of Nuclear Medicine and Molecular Imaging (SNMMI) 2024 Annual Meeting has been selected for a presentation. SNMMI 2024, held in Toronto, Canada, is recognized as the premier educational, scientific, and research event in the radiopharma space."

Preclinical • Oncology • Solid Tumor

Monopar Announces Positive Preclinical Therapeutic Isotope Data for its MNPR-101 Radiopharma Program (GlobeNewswire) - "Monopar Therapeutics Inc...announced positive preclinical imaging data of a therapeutic radioisotope bound to its proprietary uPAR (urokinase plasminogen activator receptor) targeting agent MNPR-101....Monopar collected a sequential SPECT imaging time-series utilizing MNPR-101 conjugated to Lu-177 (MNPR-101-Lu) in a uPAR-expressing human pancreatic cancer xenograft model....High specificity and durable uptake of MNPR-101-Lu in the tumor relative to normal tissue is readily apparent, and these results are consistent with the previously released data for Monopar’s diagnostic imaging radiopharmaceutical MNPR-101-Zr."

Preclinical • Gastrointestinal Cancer • Oncology • Pancreatic Cancer • Solid Tumor

Monopar Provides Update on MNPR-101-Zr Radiopharma Clinical Trial (GlobeNewswire) - "Monopar Therapeutics Inc...announced that the internationally recognized radiopharmaceutical physician, Professor Rodney Hicks, will be the lead investigator for Monopar’s MNPR-101-Zr Phase 1 dosimetry clinical trial in advanced cancer patients. Professor Hicks will enroll patients at the Melbourne Theranostic Innovation Centre (MTIC) and will use one of the world's most sensitive clinical total-body PET/CT (positron emission tomography–computed tomography) scanners, the Siemens Biograph Vision Quadra, to image the targeting ability of MNPR-101-Zr in cancer patients."

New P1 trial • Breast Cancer • Gastrointestinal Cancer • Oncology • Pancreatic Cancer • Triple Negative Breast Cancer

Monopar Receives Clearance to Proceed with First-in-Human Phase 1 Trial of Novel Radiopharmaceutical MNPR-101-Zr in Advanced Cancers (GlobeNewswire) - "Monopar Therapeutics Inc...today announced it has received Human Research Ethics Committee (HREC) clearance in Australia to commence a Phase 1 dosimetry trial of its novel radiopharmaceutical MNPR-101-Zr...The MNPR-101-Zr Phase 1 dosimetry clinical trial will enroll patients with advanced cancers and will utilize positron emission tomography (PET) imaging to assess tumor uptake, normal organ biodistribution, and safety....If the tumor uptake, biodistribution, and safety look encouraging in this Phase 1 clinical trial, which is anticipated to enroll around 12 patients and to initiate in the near future, the plan is to evaluate the efficacy in humans of a therapeutically radio-labeled version of MNPR-101 bound to an isotope such as Ac-225."

New P1 trial • Oncology

Monopar Announces Projected Timeline of Upcoming Q1 2023 Data Events for Validive, Camsirubicin, and MNPR-101 RIT (GlobeNewswire) - "February 2023: Camsirubicin Phase 1b Clinical Trial Data Update - In addition to the previously reported improvement in median progression free survival over the prior camsirubicin Phase 2 study, Monopar plans to provide details of the Phase 1b trial’s improved toxicity and safety observed to date compared to doxorubicin. MNPR-101 Radioimmunotherapeutic (RIT) Preclinical Data Update - Monopar plans to report an update on recently generated preclinical data and anticipated next steps with partner NorthStar Medical Radioisotopes."

P1 data • Preclinical • Oncology • Sarcoma • Soft Tissue Sarcoma • Solid Tumor

Monopar and NorthStar Partner with IsoTherapeutics for the Manufacturing of Potential Therapeutic for Severe COVID-19 (GlobeNewswire) - "Monopar Therapeutics Inc....and NorthStar Medical Radioisotopes, LLC...today announced a partnership with IsoTherapeutics Group, LLC (Angleton, TX), to develop and manufacture a RIT for the potential treatment of severe COVID-19. IsoTherapeutics will modify Monopar’s proprietary urokinase plasminogen activator receptor (uPAR) targeted antibody...allow the attachment of therapeutic radioisotopes supplied by NorthStar....The plan is for IsoTherapeutics to then advance...into its first in human trials."

Licensing / partnership • Infectious Disease • Novel Coronavirus Disease