Radiopharmaceutical therapy

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Radiopharm Theranostics Receives IND approval from US FDA to Initiate Phase I Therapeutic Clinical Study to target B7H3 with Betabart (RV-01)
Globenewswire· 2025-07-28 12:00
Lu177-B7H3 monoclonal antibody is first in class targeted radiopharmaceutical in development against the 4lg subtype of B7-H3 On track to initiate first-in-human study of RV-01 in solid tumors in 4Q25 "The high affinity and selectivity of RV-01 for the 4Ig isoform of B7H3 allows the antibody to bypass the soluble 2Ig isoform in the blood, boost binding of the radiopharmaceutical to tumor targets and avoid the formation of immune complexes in circulation," noted David Piwnica-Worms, M.D., Ph.D., Professor, M ...
Monopar and EDNOC Announce Expanded Access Program for MNPR-101-Zr and MNPR-101-Lu in Advanced Cancers
Globenewswire· 2025-06-11 11:00
Core Viewpoint - Monopar Therapeutics has received FDA authorization for the Expanded Access Program (EAP) for investigational imaging agent MNPR-101-Zr and therapeutic agent MNPR-101-Lu, aimed at patients with advanced solid tumors [1][2][3] Group 1: Expanded Access Program (EAP) - The MNPR-101 EAP is now open for enrollment at Excel Diagnostics and Nuclear Oncology Center (EDNOC) in Houston, Texas, targeting patients with advanced solid tumors [2][5] - EAPs provide a pathway for patients with serious or life-threatening conditions to access investigational products outside of clinical trials when no satisfactory alternative treatments are available [5] Group 2: Product Details - MNPR-101 is a proprietary antibody targeting the urokinase plasminogen activator receptor (uPAR), expressed in various tumor types including pancreatic, breast, and colorectal cancers [6] - MNPR-101-Zr is designed for imaging advanced cancers, while MNPR-101-Lu is an investigational treatment for advanced solid cancers [6] Group 3: Company Background - Monopar Therapeutics is a clinical-stage biopharmaceutical company focused on developing innovative treatments for unmet medical needs, including late-stage programs for Wilson disease and radiopharmaceuticals [7] - The company is advancing its radiopharmaceutical pipeline, which includes Phase 1 clinical trials for MNPR-101-Zr and MNPR-101-Lu [3][7] Group 4: Collaboration and Expertise - The EAP will be conducted under the supervision of Dr. Ebrahim S. Delpassand, a renowned investigator and medical director at EDNOC, which is recognized as a Radiopharmaceutical Therapy Center of Excellence [2][4][9] - The collaboration aims to provide access to therapies targeting difficult-to-treat cancers, marking a promising advancement in radioligand therapy [4]
Altamira Therapeutics .(CYTO) - 2024 H2 - Earnings Call Transcript
2025-04-30 13:02
Financial Data and Key Metrics Changes - Total operating loss from continuing operations increased from $6.6 million in 2023 to $6.9 million in 2024 [21] - Research and development expenses rose to $3.7 million in 2024 from $3.4 million in 2023 [21] - General and administrative expenses decreased from $3.5 million in 2023 to $3.2 million in 2024 [21] - Net finance expense decreased from $1.5 million in 2023 to $0.8 million in 2024 [21] - The company's net loss for 2024 was $8.5 million compared to $4.3 million in the previous year [22] - Cash and cash equivalents at year-end 2024 rose to $1 million from $0.7 million at the end of 2023 [24] Business Line Data and Key Metrics Changes - The RNA delivery business continued to gain momentum with two new partners for the X4 platform and improvements in the manufacturing process [6] - The company filed a provisional patent application for circular RNA technology, which could open new collaboration opportunities [12] - Significant progress was made in the development and refinement of nanoparticles for RNA payload delivery [11] Market Data and Key Metrics Changes - The global radiopharmaceutical market reached $8.4 billion in size in 2024 and is expected to grow to $17.1 billion by 2033 [13] Company Strategy and Development Direction - The company plans to spin off a majority of its Swiss subsidiary, Altamira Therapeutics AG, to focus on RNA delivery business [9] - The parent company will become more of a holding company, managing minority stakes in subsidiaries and legacy assets [9] - The company aims to advance at least one flagship program to an investigational new drug IND filing with the FDA in 2026 [14] Management's Comments on Operating Environment and Future Outlook - The delisting from NASDAQ was a significant setback, impacting the ability to raise capital in public markets [27] - The planned partial spin-off and involvement of private equity investors are seen as beneficial alternatives for funding and growth [27] - The company expects operating expenses to decrease significantly following the spin-off [24] Other Important Information - The financial results for 2024 were presented in U.S. dollars for the first time [20] - The company is in discussions with potential partners for its legacy assets, including nasal sprays for allergy and vertigo treatment [19] Q&A Session Summary - No specific questions or answers were documented in the provided content.