Imugene Ltd (ASX:IMU, OTC:IUGNF) marked a milestone today with the start of its Phase 1 clinical trial for onCARlytics, a CD19 oncolytic virotherapy drug candidate.
Targeting metastatic solid tumours
The trial, known as OASIS (Oncolytic Assessment and Safety in Solid Tumours), represents a world-first in clinical research, combining CD19 oncolytic virotherapy with a CD19 targeting bispecific monoclonal antibody, blinatumomab (Blincyto® Amgen (NASDAQ:AMGN)).
The primary objective of the OASIS trial is to assess the safety and tolerability of onCARlytics (CF33-CD19) when administered intravenously or intratumorally in combination with blinatumomab.
The trial targets adult patients with advanced or metastatic solid tumours, a patient group that has limited treatment options.
This groundbreaking approach seeks to make solid cancers visible and vulnerable to attack by approved CD19 drugs, including Amgen's Blincyto® and Gilead (NASDAQ:GILD)'s Yescarta®.
Multiple sites across US
The OASIS trial is designed as a dose escalation study and is being conducted at multiple sites across the US.
The first patient, diagnosed with ovarian cancer, has already been dosed at the City of Hope's NCI-Designated Comprehensive Cancer Center in Duarte, California, USA.
onCARlytics represent a potential game-changer in the field of oncology, expanding treatment options for solid tumour patients who have exhausted other avenues.
This Phase 1 clinical trial marks a significant step towards bringing this innovative therapy to those in need.
Imugene managing director and CEO Leslie Chong said: “This is a milestone we’ve been eagerly anticipating, given the encouraging signs we have seen from the pre-clinical work performed to date.
“We believe onCARlytics may provide a new solution for clinicians treating solid tumours that have previously been untreatable using CD19-targeting biological drugs, and we hope our technology can bring much needed relief to patients in want of new treatments.
“I am particularly pleased with the speed at which our team drove the pre-clinical data from a novel therapy, into a Phase 1 trial in a little over two years, and reflects the enthusiasm for this promising therapy, from all involved.”