++Imagion Biosystems (ASX: IBX)++ has received positive results on dosage tests in preparation for a Phase 2 clinical trial of HER2 breast cancer imaging agent MagSense.
Testing in collaboration with Wayne State University (WSU) in Michigan focused on establishing the lower limits of detectability to help establish the dose range for the trial and optimise magnetic resonance imaging (MRI) protocols for improved quality.
The collaboration confirmed that a lower dose of MagSense than that used in the Phase 1 study is likely to still be detectable, which is an important step for clinical development that strengthens the product’s safety profile while delivering a better care experience for patients.
Optimised Sequence Improvement
WSU’s optimised sequences improved upon MRI sequences the company used in the Phase 1 study and will serve as the foundation for imaging procedures at sites participating in the Phase 2 trial.
Additionally, the use of quantitative imaging protocols in combination with molecular imaging agents may create AI-ready imaging data to improve and democratise the trial’s diagnostic accuracy.
Imagion will use the results to support an investigational new drug (IND) application for the Phase 2 trial, which it will submit to the US Food and Drug Administration before year end.
Analytical testing of a ++newly manufactured batch of MagSense++ is currently underway and on track for inclusion in the trial following approval of the application.
Better Dosage Understanding
Imagion chief business officer Ward Detwiler said the company was happy with the collaboration’s outcomes.
“Optimised protocols and a better understanding of minimum dosages give us further confidence as we move forward toward our planned IND application this year,” he said.
“Furthermore, the findings from quantitative MRI techniques that could unlock greater diagnostic precision through AI are extremely encouraging.”
Commonly Diagnosed Cancer
Breast cancer is one of the most commonly-diagnosed cancers and the second leading cause of cancer death among women.
Current breast cancer diagnosis relies on nodal assessment via physical examination or conventional imaging techniques such as ultrasound that aim to identify abnormal nodes but cannot confirm the presence of cancer.
Of the four subtypes of breast cancer, HER2 represents up to 20% of diagnoses and has significant prognostic and predictive implications due to it being an aggressive phenotype with a high rate of recurrence and metastasis.
Imagion developed MagSense to assess axillary nodal disease in patients diagnosed with HER2, and the company believes it will be of significant clinical value to the more than 400,000 females diagnosed globally each year.
