On April 2, 2025 Imugene Limited (ASX: IMU), a clinical-stage immuno oncology company, reported 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 (Press release, Imugene, APR 2, 2025, View Source [SID1234651765]).
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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:
"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."