Medicenna Therapeutics' subsidiary Medicenna BioPharma has begun dosing patients in the Phase IIb trial of its MDNA55 to treat recurrent glioblastoma (rGB).
MDNA55 is a form of targeted immunotherapy being developed to remove tumour cells and adjacent immunosuppressive cells present in the tumour microenvironment that over-express interleukin-4 receptor (IL4R).
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The multi-centre, single-arm, open-label Phase IIb trial will evaluate MDNA55 in around 43 adult patients who have progressed or recurred after prior therapy.
A single intra-tumoural infusion of MDNA55 will be given through convection enhanced delivery (CED) technique, which is expected to result in minimal systemic side effects.
Medicenna chairman and chief executive officer Dr Fahar Merchant said: "Dosing the first patient in this clinical trial is a significant milestone for the company as we look to build upon the promising results from earlier studies with MDNA55.
"We are pleased to be working with leading neuro-surgical centres in the US as we explore the benefits of MDNA55 for the treatment of rGB and other types of brain cancer."
The primary endpoint of the trial is measure of overall response rate (ORR) using magnetic resonance imaging and the revised assessment in neuro-oncology (RANO) criteria.
The trial will also assess secondary outcomes such as progression-free survival, overall survival and exploratory predictors of outcome examined utilising IL4R expression in archived tumour biopsies.
The trial's enrolment will be conducted at up to ten sites in the US and is estimated to be completed by the end of this year, while the top-line data is expected to be available in the first half of next year.
