Ann: 1st dose level cleared IV combination arm onCARlytics trial, page-2

The first dose level has been cleared in the intravenous (IV) combination arm of the
OASIS trial, targeting adult patients with advanced or metastatic solid tumours
• This first in human study aims to make solid tumours express the validated CD19
target, rendering them vulnerable to be attacked by approved CD19 targeting
therapies.
• Dose escalation to follow as the trial progresses toward full recruitment of 40-50
patients
Sydney, Australia, 3 April 2025: Imugene Limited (ASX: IMU), a clinical-stage immuno
oncology company, is pleased to announce it has received clearance from the Cohort
Review Committee (CRC) to escalate the dose level in the intravenous (IV) combination
arm of its Phase 1 onCARlytics trial.
With the successful completion of the safety observation period the IV combination arm
will progress to a higher dose level.
Known as OASIS, the Phase 1 dose escalation onCARlytics clinical trial is targeting adult
patients with advanced or metastatic solid tumours. The trial aims to evaluate the safety
and efficacy of two routes of administration, intratumoural (IT) injection and intravenous
(IV) infusion of either onCARlytics (a CD19-expressing oncolytic virus) alone, or in
combination with CD19 targeting bispecific monoclonal antibody blinatumomab
(Blincyto®), which is a cancer immunotherapy.
OASIS is being conducted at seven sites in the U.S. including City of Hope, University of
Cincinnati, MD Anderson Cancer Center, Emory, Roswell Park, University of Pittsburgh,
Northwestern and University of Nebraska, with the potential to open a total of 10 sites to
recruit approximately 40-50 patients with advanced solid cancers that have spread.
Imugene’s Managing Director and Chief Executive Officer, Leslie Chong, said:
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“CD19 is a very significant target for blood cancers, but solid cancers like breast, lung or
gastric do not have a common target on their cell surface, and therefore the aim with
onCARlytics is to make available a target for CD19 therapies to treat these solid cancers. As
the trial continues to progress and dose escalation is executed, we are eager to learn of the
potential impact our treatment is having for patients in need.”
The 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