Imagion Resumes MagSense® Nanoparticle Manufacturing Capabilities
Imagion Biosystems, Ltd. (ASX: IBX) announced it will resume MagSense® Nanoparticle manufacturing capabilities ahead of its Phase 1b/2 clinical trial and potential commercialization. The company has contracted nanoComposix, a nanoparticle Contract Development and Manufacturing Organization (CDMO). Under the signed agreement, Imagion will provide the proprietary nanoparticle synthesis equipment, software and procedures required for the CDMO to start manufacturing under the company’s direction.
Imagion Biosystems Secures AU$3.75M in Capital Raise Following FDA Clearance of Phase 2 Clinical Trial
Imagion Biosystems, Ltd. (ASX: IBX) announced that it has secured firm commitments for AU$3.75M (US$2.59M) in new capital following the FDA’s clearance of the company’s IND application for a Phase 2 clinical trial. The raise will fund the commencement of the clinical trial of the MagSense® imaging agent in HER2+ breast cancer. The company has already begun trial activation activities and expects to begin patient recruitment later this year.
Imagion Biosystems’ IND Application for MagSense® Phase 2 Clinical Trial Clears FDA Review
Imagion Biosystems, Ltd. (ASX: IBX) has announced that the US Food and Drug Administration (FDA) completed its review of the company’s investigational new drug (IND) application, issuing a “Study May Proceed” letter for Phase 1b/2 clinical trials of the MagSense® Imaging Agent in HER2+ breast cancer.
Medical-imaging company Imagion Biosystems Lodges IND with FDA for Phase 2 Trial of MagSense® HER2 targeted imaging agent
Imagion Biosystems, Ltd. (ASX: IBX) announced that the company has lodged an Investigational New Drug (IND) application with the U.S. Food and Drug Administration (FDA) for its MagSense® targeted imaging agent. Following FDA approval, the company expects to start a Phase 2 clinical trial with the imaging agent for the detection of nodal metastases in HER2+ breast cancer patients.
