Imugene (ASX: IMU) has confirmed the delivery of its first “onCARlytics” combination therapy dose to a bile duct cancer patient in the initial phase of a world-first trial at the City of Hope medical centre in the United States.
The dose delivered to the patient living with the condition also known as “cholangiocarcinoma” – a rare and aggressive cancer that originates in the bile ducts and typically shows a poor response to established immunotherapy drugs – is the first in the intravenous (IV) infusion combination arm of the company’s “OASIS” trial that is expected to enrol up to 45 patients with advanced solid cancers.
Back in February, the company dosed its first bile tract cancer patient in the IV monotherapy arm of the trial at the same site in California.
The trial has been designed to evaluate the safety and efficacy of both intratumoural injection and intravenous infusion. It is the first of its kind globally where an oncolytic virus that expresses the cancer marker “CD19” is being combined with a drug that targets CD19.
Oncolytic virus (OV) therapy uses modified viruses that can selectively infect and destroy tumour cells. The primary objective of Imugene’s plan is to convert difficult-to-treat “targetless” tumours into masses that can be recognised by its onCARlytics therapy, either on its own or in combination with a cancer immunotherapy known as “Blincyto.”
While CD19 has been a powerful target for blood cancers, no such targets currently exist for solid cancers. We aspire to change that with onCARlytics, which causes cancers to display CD19 on their cell surface so that an approved CD19 therapeutics can target and kill the cancer.
Imugene managing director and CEO Leslie Chong
Chong said that if successful, onCARlytics could open up 90 per cent of the market as CD19 products have only been approved in blood cancer treatment to date and could provide a new medical option for patients with solid tumors.
The onCARlytics therapy is a CD19 oncolytic virus that enters solid tumour cells and stimulates them to display a marker or protein on the surface of cancer cells. It makes the cancer cell a target for already-approved CD19-targeting drugs such as blinatumomab, which kills blood cancer cells exhibiting CD19 targets.
More dominant solid cancers such as breast, lung, gastric and colon and others lack common targets on their cell surfaces. Subject to the rate of patient enrolment, Imugene says preliminary data from its early combination trials are expected in the last quarter of this year.
A successful trial could mean the availability of a new treatment option for millions of patients with solid tumours in a market that is estimated to be valued at about US$532 billion (AU$801 billion) by 2032.
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