Imugene (ASX:IMU) achieves FDA clearance to begin first-in-class onCARlytics study

• Imugene (IMU) receives US Food and Drug Administration (FDA) Investigational New Drug (IND) clearance to begin a study of its oncolytic virotherapy candidate, onCARlytics
• Through this clearance, IMU can start patient recruitment and dosing in a first-in-class phase-one study for patients with solid tumours
• IMU MD and CEO Leslie Chong says FDA clearance is a “crucial step forward”
• The company’s CF33-CD19 oncolytic virus, when combined with the CD19 targeting bispecific monoclonal antibody Blicyto, can target and eradicate solid tumours
• Shares in IMU were up 8.7 per cent, trading at 12.5 cents at 11:00 am AEST

Imugene (IMU) has received US Food and Drug Administration (FDA) Investigational New Drug (IND) clearance to begin a phase one study of its oncolytic virotherapy candidate, onCARlytics.

The company announced the clearance meant it can start patient recruitment and dosing in a first-in-class study for patients with solid tumours.

Imugene Managing Director and CEO Leslie Chong said achieving FDA clearance was a “crucial step forward”.

“The start of our onCARlytics study, which is first-in-class, is a significant milestone for clinicians treating patients faced with the challenge of solid tumour cancers, which to date have been untreatable with CD19-targeting biological drugs,” she said.

“Accomplishing this goal speaks to the perseverance and dedication of Imugene’s and City of Hope’s research and development teams as we continue to build on our clinical and commercial potential.”

The company reported its CF33-CD19 oncolytic virus, when combined with the CD19 targeting bispecific monoclonal antibody Blicyto, has the potential to target and eradicate solid tumours that otherwise cannot be treated with Blicyto therapy alone.

Shares in IMU were up 8.7 per cent, trading at 12.5 cents at 11:00 am AEST.