Imagion Biosystems advances MagSense HER2 imaging agent with FDA application

Cancer detection specialist Imagion Biosystems (ASX: IBX) has taken the next step in progressing its MagSense HER2 imaging agent, lodging an application with the US Food and Drug Administration (FDA).

The application for initiated manufacturing of MagSense HER2 is an essential requirement for filing an Investigational New Drug (IND) application with the FDA in mid-2025.

The company is developing MagSense HER2 to assist with the assessment of axillary nodal disease in patients diagnosed with HER2+ breast cancer.

Aggressive phenotype

The HER2-positive subtype of breast cancer is an aggressive phenotype with a high rate of recurrence and metastasis, leading to the need for the development of a more sensitive and specific imaging method.

Ultrasound is currently the most commonly employed method for assessing HER2+, with pooled diagnostic sensitivity and specificity of 49% to 87% and 55% to 97%, respectively.

Imagion executive chair Bob Proulx said precise nodal staging is an essential component in the management of patients with breast cancer, with the successful creation of MagSense HER2 of significant clinical value for the more than 400,000 patients diagnosed with HER globally each year.

With a production schedule from the contract manufacturer now in hand, the company is confident it can establish a timeline for completing the additional key tasks and anticipates being able to file the IND application 30 to 60 days after manufacturing has been completed.

Basic safety milestone

Imagion has already achieved a key milestone in assessing the basic safety of MagSense HER2 with the successful completion of a Phase 1 study.

Under Phase 2, the company will look to optimise the dose of the imaging agent and the imaging protocol to establish the diagnostic performance.

The company has previously made two batches of the imaging agent, which were used in the Phase 1 study.

It will use a new batch of material in the Phase 2 study that will be proposed to the FDA in the IND application.

Based on the contract manufacturer’s availability of the GMP suite, Imagion expects to commence manufacture in mid-April and complete production in June.

Successful capital raising

The $3 million in proceeds from a capital raising the company conducted in 2024 will support the new work on MagSense HER2.

“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,” Mr Proulx said.

“With this key activity now in process, we are marching towards our next key development milestone.”