- 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
- OASIS potentially represents a paradigm shift in solid tumour treatment
- 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 treated to date in the monotherapy arm
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, intratumoral (IT) injection and intravenous (IV) infusion, either alone, or in combination with blinatumomab.
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
The combination arm of the study will see onCARlytics combined with CD19 targeting bispecific monoclonal antibody blinatumomab (marketed as Blincyto® by Amgen which currently is specifically approved only for liquid blood cancers). onCARlytics has the potential to target and eradicate solid tumours that otherwise cannot be treated with Blincyto® therapy alone and will represent a paradigm shift in solid tumour treatment.
OASIS is a dose escalation trial that will be conducted across multiple sites across
Imugene Managing Director and CEO
“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 intratumoral 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.”
onCARlytics is a CD19-expressing oncolytic virus that enters tumour cells and forces them to express the CD19 protein on the cell surface, presenting a target for CD19 targeting therapies.
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