Imagion Biosystems Starts Manufacture of MagSense Imaging Agent for Phase 2 HER2 Breast Cancer Trial

Imagion Biosystems (ASX: IBX) has commenced manufacturing of its MagSense imaging agent ahead of a Phase 2 HER2 breast cancer clinical trial to start in the US before year end.

The agent will assess axillary nodal disease in patients diagnosed with HER2+ breast cancer and Imagion believes it will be of significant clinical value to the more than 400,000 females diagnosed globally each year.

The company has also advanced its communications with the US Food and Drug Administration (FDA) regarding an investigational new drug (IND) application later this year, subject to completion of analytical testing of the imaging agent.

Trial Still Primary Focus

Executive chair Bob Proulx said the trial and IND submission remain the company’s primary focus.

“Establishing the appropriate manufacturing processes and analytical testing methods are critical in the product development process—if it is not done correctly at this stage, it could delay future trials and regulatory authorisation,” he said.

“By developing robust manufacturing processes now, we can ensure that the appropriate methods are in place and avoid any future delays in the development program as we work towards potential commercialisation.”

MRI Protocol Agreement

Imagion has entered into a collaborative service agreement with magnetic resonance imaging (MRI) experts at Wayne State University School of Medicine in Michigan to develop optimised imaging protocols for use with the MagSense HER2 imaging agent.

The project aims to determine the lowest concentration (or dose) of MagSense it needs in order to achieve detection sensitivity for clinical utility, and will include the outcomes in the IND application.

Imagion anticipates implementing the new protocols at each clinical site of the Phase 2 trial with the support of Siemens Healthineers under an existing collaboration agreement.

“The quantitative imaging techniques pioneered by Wayne State University researchers could significantly improve the diagnostic utility of our molecular MRI technology and set the stage for the development of artificial intelligence diagnostic tools using data from the Phase 2 trial,” Mr Proulx said.

New Director Appointed

Imagion has appointed Dr Nina Webster to its board as a non-executive director.

Dr Webster has held leadership roles in the biotechnology and drug development space for over 30 years and currently serves as managing director of clinical-stage biopharmaceutical company Dimerix (ASX: DXB), which is developing a portfolio of drugs to treat inflammatory diseases.

Her former roles include commercial director of Acrux (ASX: ACR) and director of commercialisation and intellectual property for Immuron (ASX: IMC), and she currently serves as non-executive chairperson for SYNthesis BioVentures and non-executive director for Linear Clinical Research.

Mr Proulx said Dr Webster would be a welcome addition to Imagion’s leadership team as the company continues to mature and develop its pipeline of MagSense molecular imaging technologies.