In a world first, ASX-listed medtech Imugene has dosed the first cancer patient with its novel onCARlytics CD19 virus technology which it says has the potential to target and eradicate solid tumours.
onCarlytics is a novel “immunotherapy” utilising the CF33 oncolytic virus to deliver and present CD19 antigen on the surface of cancer cells. It enhances the expression of CD19 and allows it to be better targeted by cancer-fighting drugs.
Imugene is seeking to harness and enhance the body’s own immune system through the use of immunotherapies – a class of medical treatment that is gathering attention at a rapid rate of knots.
The new trial, for adult patients with advanced or metastatic solid tumours, aims to evaluate the safety and efficacy of two routes of administration, intratumoral injection and intravenous infusion, either alone or in combination with blinatumomab - or CD19 targeting agents.
The company says introducing the virus can reverse the tumour’s suppressed microenvironment, making it more receptive to receiving CD19 targeting cell therapy.
The therapy seeks to turn and render solid cancers visible and vulnerable to attack from approved CD19-targeting drugs such as Amgen’s “Blincyto” and Gilead’s “Yescarta”, and in the future, Imugene’s CAR T cell therapy drug “Azer-cel”.
Imugene is angling to provide the lucrative health industry with its first approved off-the-shelf CAR T-cell cancer therapy with Azer-cel. The company previously reported positive feedback from the United States Food and Drug Administration on its proposed trials and commercial manufacture of Azer-cel to treat patients with certain blood cancers.
Blood cancers however only represent about 10 per cent of all cancer types and the success of these therapies in the setting of solid tumours, which make up about 80 per cent of all cancers, has been limited.
In pre-clinical trials on triple-negative breast, pancreatic, prostate, ovarian, brain and head and neck cancers in mice, onCARlytics in combination with CD19 targeting cell therapy has shown greater potency against solid tumours than either CF33 or CD19 targeting therapy alone according to the company.
Imugene says research showed mice were cured of their solid tumours with the onCARlytics in combination with CAR T cell therapy. The previous trials revealed that once the immune system eradicates the tumours with the combination treatment, it builds a memory response shielding the mice against tumour recurrences.
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. Imugene managing director and chief executive officer Leslie Chong
In a little more than two years, Imugene has taken its promising onCARlytics CD19 virus technology from pre-clinical trials treating mice to its first phase-1 clinical trial treating a patient at City of Hope’s National Cancer Institute in California.
Immunotherapy is an exciting development for cancer sufferers in particular. At face value at least, the idea of simply enhancing a patient’s own immune system to fight the disease seems to make sense.
Imugene is in the vanguard of immunotherapy developers and all eyes will be on the results of the new trial.
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