Imugene (ASX: IMU) has cleared the first hurdle in its clinical trial to test the safety and efficacy of its “onCARlytics” treatment for solid tumours after receiving the green light to advance to the combination phase.
Management says the trial’s Cohort Review Committee observed no safety issues in the onCARlytics single therapy lead-in study and recommended opening the combination phase of testing.
The trial, known as OASIS, is targeting adult patients with advanced or metastatic solid tumours and aims to evaluate the safety and efficacy of both intratumoural (IT) injection and intravenous (IV) infusion. The study is focused on Imugene’s “onCARlytics CD19” virus technology, which it says has the potential to target and eradicate solid tumours.
While CD19 is currently only known as a marker in blood cancers, Imugene’s virus is injected into a patient with a view to replicating the marker in solid tumours and forcing it to the surface so that it can be hunted down and destroyed. The trial is considered a world-first in combining a CD19-expressing oncolytic virus with a CD19-targeting drug.
The next phase of the study will combine the company’s onCARlytics therapy with fellow ASX-listed medtech Amgen’s CD-19-targeting drug “blinotumamab”, which is marketed as “Blincyto” and is currently only specifically approved to treat for liquid blood cancers. Other potential CD-19-targeting therapeutics include Gilead’s Yescarta and Imugene’s own allogeneic “CAR T azer-cel” treatment.
Management says onCARlytics has the potential to target and eradicate solid tumours that otherwise can not be treated with Blincyto therapy alone and will represent a paradigm shift in solid tumour treatment.
Completion of this first monotherapy intratumoural cohort where ovarian, breast and melanoma patients were dosed paves the way for us to move into an important combination dosing with Blincyto, where we’ll be eager to see the greater potential of onCARlytics in targeting and eradicating solid tumours.
Imugene managing director and chief executive officer Leslie Chong
The OASIS trial is aiming to evaluate the safety and efficacy of IT injection and IV infusion, either alone, or in combination with blinatumomab. To date, only ovarian, breast and melanoma patients have been treated during the single therapy arm of the study.
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.
It says research showed mice were cured of their solid tumours by using onCARlytics in combination with CAR T-cell therapy. Previous trials revealed that once the immune system eradicated the tumours with the combination treatment, it built a memory response that shielded the mice against tumour recurrences.
Receiving the green light to move onto the combination stage of the OASIS trial represents a significant step forward for Imugene, with the study to be conducted across multiple sites in the United States and 52 patients proposed to take part.
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