Imugene Limited has commenced the intratumoral arm of its Phase 1 OASIS (oncolytic assessment and safety in solid tumours) trial, dosing the first patient at Northwestern University in the US. This trial evaluates Imugene’s onCARlytics (CF33-CD19) in combination with Amgen's blinatumomab (Blincyto®) in patients with advanced or metastatic solid tumors.
The OASIS trial is a first-in-human clinical study combining Imugene's CD19 oncolytic virotherapy with a CD19-targeting bispecific monoclonal antibody. The primary objective is to assess the safety and tolerability of onCARlytics when administered intratumorally (IT) in combination with blinatumomab.
The trial targets adult patients with advanced or metastatic solid tumors who have limited treatment options. The combination approach is designed to induce CD19 expression on the surface of solid tumors, rendering them susceptible to existing CD19-directed therapies. This strategy aims to convert tumors that are typically 'invisible' to these therapies into targets that can be recognized and attacked.
onCARlytics Mechanism and Trial Design
onCARlytics has the potential to induce the expression of CD19 on solid tumors, allowing CD19 therapies to recognize and attack the cancer. When combined with blinatumomab, onCARlytics can target and eradicate solid tumors that are otherwise untreatable with blinatumomab alone.
The OASIS trial is being conducted across seven sites in the US and may expand to a total of 10 sites, with the capacity to enroll up to 40 patients with advanced solid cancers that have metastasized. The trial will evaluate the safety and efficacy of onCARlytics administered both intratumorally (IT) and intravenously (IV), either alone or in combination with blinatumomab.
In February, the first patient with bile tract cancer was dosed in the intravenous (IV) monotherapy component of the trial at City of Hope in California. Preliminary data from the IT and/or IV combination arms are expected in the fourth quarter of 2024.
Clinical Significance
The trial represents a significant step forward in developing new treatment options for patients with advanced solid tumors. By converting 'targetless' tumors into CD19-expressing targets, onCARlytics has the potential to expand the applicability of existing CD19-directed therapies to a broader range of cancers.
