Imugene’s onCARlytics clears Phase 1 milestone in solid tumour therapy trial

Clinical stage immuno-oncology company Imugene (ASX: IMU) has confirmed that a Phase 1 clinical trial of lead drug candidate onCARlytics has cleared its first cohort within the intra-tumoural monotherapy arm of the study.

Known as OASIS, the first-in-class trial combines a CD19-expressing oncolytic virus that flags solid tumours for attack by CD19-targeting therapeutics such as Blincyto (marketed by Amgen), Yescarta (Gilead) and Imugene’s own allogeneic CAR T, azer-cel (azercabtagene zapreleucel).

OnCARlytics enters tumour cells and forces them to express the CD19 protein on the cell surface, presenting a target for CD19-focused therapies.

No safety issues

The trial’s cohort review committee reported no safety issues in the onCARlytics monotherapy lead-in part of the study, which treated patients with melanoma, as well as ovarian and breast cancers.

The committee has since recommended that Imugene progress to the combination dosing arm of the study, which will see onCARlytics combined with CD19-targeting bispecific monoclonal antibody blinatumomab (Blincyto).

Blinatumomab is currently approved only for the treatment of liquid blood cancers.

Paradigm shift

Managing director Leslie Chong said that onCARlytics has the potential to target and eradicate solid tumours that otherwise cannot be treated with Blincyto therapy alone, representing a paradigm shift in solid tumour treatment.

“Completion of this first monotherapy intratumoural cohort […] paves the way for us to move onto an important combination dosing stage with Blincyto,” she said.

“We’ll be eager to see the greater potential of onCARlytics in targeting and eradicating solid tumours.”

Dose escalation trial

OASIS is a dose escalation trial targeting adult patients with advanced or metastatic solid tumours.

It aims to evaluate the safety and efficacy of two routes of administration — intratumoural injection and intravenous (IV) infusion — either alone or in combination with blinatumomab.

The trial is being conducted across multiple US sites, with 52 patients proposed to take part.

Last month, Imugene reported it had dosed the first patient of the IV monotherapy arm at the City of Hope cancer treatment centre in California.