Imagion Biosystems Initiates Manufacturing of MagSense HER2 Imaging Agent for FDA Application
Key Insights
Imagion Biosystems (search) has initiated manufacturing of its MagSense HER2 imaging agent (search) as an essential requirement for filing an Investigational New Drug application with the FDA in mid-2025.
The imaging agent is designed to assess axillary nodal disease (search) in HER2-positive breast cancer (search) patients, targeting a more aggressive cancer subtype that affects over 400,000 patients globally each year.
Manufacturing is expected to commence in mid-April and complete in June, with the company anticipating IND filing within 30-60 days after production completion.
Imagion Biosystems (search) has initiated manufacturing of its MagSense HER2 imaging agent (search), marking a critical milestone toward filing an Investigational New Drug (IND) application with the US Food and Drug Administration (search) in mid-2025. The cancer detection specialist lodged the manufacturing application as an essential requirement for advancing its novel imaging technology into Phase 2 clinical trials.
Targeting Aggressive HER2-Positive Breast Cancer
The MagSense HER2 imaging agent (search) is being developed to assess axillary nodal disease (search) in patients diagnosed with HER2-positive breast cancer (search). This cancer subtype represents an aggressive phenotype with high rates of recurrence and metastasis, creating an urgent need for more sensitive and specific imaging methods.
Currently, ultrasound serves as the most commonly employed assessment method for HER2-positive breast cancer (search), but demonstrates limited diagnostic accuracy with pooled sensitivity ranging from 49% to 87% and specificity from 55% to 97%. The development of MagSense HER2 (search) could provide significant clinical value for the more than 400,000 HER2 breast cancer (search) patients diagnosed globally each year.
"Precise nodal staging is an essential component in the management of patients with breast cancer (search), with the successful creation of MagSense HER2 (search) of significant clinical value," said Bob Proulx, Executive Chairman of Imagion Biosystems (search).
Manufacturing Timeline and Regulatory Pathway
Based on the contract manufacturer's availability of the Good Manufacturing Practices (GMP) suite, manufacturing is expected to commence in mid-April with production completion scheduled for June. The company anticipates filing the IND application within 30 to 60 days after manufacturing completion.
Imagion has previously manufactured two batches of the imaging agent for its Phase 1 study, which successfully achieved a key milestone in assessing basic safety. This new batch will be used in the proposed Phase 2 study and must comply with FDA guidance for Good Manufacturing Practices for human clinical investigational use.
Phase 2 Study Objectives
The Phase 2 clinical study represents a critical development step for both the MagSense HER2 imaging agent (search) and the broader MagSense imaging technology platform. The study aims to optimize the dose of the imaging agent and refine the imaging protocol to establish diagnostic performance parameters.
Key tasks associated with meeting the IND milestone include establishing a Principal Investigator to lead the study and engaging with that investigator to finalize the study protocol in accordance with FDA recommendations.
Financial Support and Future Funding
The $3 million raised through a 2024 capital raising will support the current manufacturing and IND preparation activities. "The receipt of funds from our recent capital raise has provided us with the resources needed to aggressively pursue our goal of filing an IND and preparing for the next phase of clinical testing of our novel imaging technology," Proulx stated.
While the company has sufficient capital to proceed with activities necessary for IND filing, additional funding will be required to conduct the Phase 2 study once FDA approval is obtained.