Imagion Biosystems Limited provided an update on development plans for its MagSense® HER2 imaging agent. Based on feedback the Company has received from the U.S. Food and Drug Administration (FDA), the Company plans to proceed with a multi-site Phase 2 clinical trial in the US. The Phase 2 study will investigate various clinical endpoints while optimizing dose and imaging parameters, which will be necessary before committing to a Phase 3 pivotal study.

The Company has previously reported favourable interim safety and tolerability data from its Phase 1 clinical study and had undertaken an independent expert review to corroborate the prospective ability of its MagSense HER2 Imaging Agent to detect suspicious nodes using Magnetic Resonance Imaging (MRI) in patients with HER2-positive breast cancer (link to announcement). The Phase 1 data and independent review have provided the foundation for the Company now to pursue use of the MagSense® nanoparticle technology for molecular imaging of cancer with mainstream MRI detection. Expanding clinical trials into the U.S. requires filing an Investigational New Drug (IND) application with the FDA.

As previously disclosed, the Company had initiated communication with the FDA earlier this year and is now pleased to report that the feedback from the FDA is in agreement with the key elements of the Company's proposed Phase 2 study design and provided further guidance and recommendations as it relates to the completeness of the Company's nonclinical and clinical Phase 1 data package which would form part of the IND application. The Company notes that the guidance and recommendations are consistent with regulatory oversight for products entering Phase 2 of clinical investigations. The FDA guidance is an important milestone that enables the Company to proceed with preparing and filing the IND.

Accordingly, activities in the coming quarters include: Collecting additional non-clinical and clinical data (pharmacokinetics) in support of commencing a US Phase 2 study; Manufacturing additional MagSense® HER2 imaging agent material to support the US Phase 2 study; and Establishing the initial clinical investigators and sites to support the study. The Company expects to be able to file the IND submission in Fourth Quarter of 2023 or First Quarter of 2024.