Imugene Ltd (ASX:IMU, OTC:IUGNF) is ready to begin combination dosing solid tumour patients with CD19 targeting drug blinatumomab as part of a Phase 1 clinical trial of CD19 oncolytic virotherapy drug candidate onCARlytics (on-CAR-19, CF33-CD19 HOV4).
The combination arm of the study treatment will see onCARlytics combined with CD19 targeting bispecific monoclonal antibody blinatumomab (marketed as Blincyto® by Amgen (NASDAQ:AMGN) which currently is specifically approved only for liquid blood cancers).
Progression to this phase follows onCARlytics clearing its first cohort within the intratumoural monotherapy arm of the study.
About OASIS trial
Known as OASIS, the first-in-class clinical trial is targeting adult patients with advanced or metastatic solid tumours and aims to evaluate the safety and efficacy of two routes of administration, intratumoural (IT) injection and intravenous (IV) infusion, either alone, or in combination with blinatumomab.
This trial is titled: 'A Phase I, Dose Escalation and Dose Expansion, Safety and Tolerability Study of onCARlytics (CF33-CD19), Administered Intravenously or Intratumorally in Combination with Blinatumomab in Adults with Advanced or Metastatic Solid Tumors'. See https://clinicaltrials.gov/study/NCT06063317.
“Important combination dosing”
Imugene managing director and CEO Leslie Chong said: “It’s once again a credit to our team and collaborators to see yet another study progressing positively and on schedule.
"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."
No safety issues
The Cohort Review Committee (CRC) observed no safety issues in the onCARlytics monotherapy lead-in study and recommended opening of the combination arm of the study.
Ovarian, breast and melanoma patients have been treated to date in the monotherapy arm.
The OASIS trial is a first-in-class clinical trial combining a CD19-expressing oncolytic virus, which flags solid tumours for attack by CD19-targeting therapeutics such as Amgen’s Blincyto®, Gilead’s Yescarta® and Imugene’s own allogeneic CAR T, azer-cel.
OnCARlytics has the potential to target and eradicate solid tumours that otherwise cannot be treated with Blincyto® therapy alone and, as such OASIS potentially represents a paradigm shift in solid tumour treatment.
OASIS is a dose escalation trial that will be conducted across multiple sites across the United States, with 52 patients proposed to take part in the trial.