Ann: Next cohort reached in IV arms of CF33-hNIS (VAXINIA) study, page-2

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Imugene MD & CEO Leslie Chong said: “As we near closer to opening and completing the
final cohorts that were planned at the beginning of the trial, we have an opportunity to
expand the trial by enrolling patients in additional cohorts for the monotherapy dose
escalation component. This will provide us with a far more robust data set to analyse and
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speak to at the conclusion of the MAST study, and provide us with a stronger platform as
we further the clinical development of CF33 and VAXINIA.”
The multicenter Phase 1 MAST trial commenced by delivering a low dose of VAXINIA to
patients with metastatic or advanced solid tumours who have had at least two prior lines
of standard of care treatment. The City of Hope-developed oncolytic virus has been
shown to shrink colon, lung, breast, ovarian and pancreatic cancer tumours in preclinical
laboratory and animal models¹. Overall the study aims to recruit up to 100 patients across
approximately 10 trial sites in the United States and Australia.
The clinical trial is titled “A Phase I, Dose Escalation Safety and Tolerability Study of
VAXINIA (CF33- hNIS), Administered Intratumorally or Intravenously as a Monotherapy or
in Combination with Pembrolizumab in Adult Patients with Metastatic or Advanced Solid
Tumours (MAST).” The trial commenced in May 2022 and is anticipated to run for
approximately 24 months while being funded from existing budgets and resources.
Full study details can also be found on clinicaltrials.gov under study ID: NCT05346484