Medicenna to present bizaxofusp rGBM survival data at SNO 2026

Medicenna's IL-4-targeted glioblastoma candidate will receive an oral slot at the Society for Neuro-Oncology meeting in November.

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A modern MRI scanner with its patient table sits in a brightly lit medical room with large windows on the left and a desk with three monitors on the right.

Medicenna Therapeutics has secured an oral presentation slot at the 31st Annual Meeting of the Society for Neuro-Oncology (SNO 2026), where new survival data for its lead candidate bizaxofusp in recurrent glioblastoma (rGBM) will be presented on 13 November in Philadelphia.

The abstract covers survival outcomes in unresectable, IDH-wildtype rGBM patients using a propensity score-weighted external control arm, analysed in the population Medicenna intends to enrol in a prospective Phase 3 study. The presentation will be delivered by Dr Nicholas Butowski, Professor of Neurological Surgery and Director of Translational Research in Neuro-Oncology at the University of California, San Francisco.

The candidate and its mechanism

Bizaxofusp, formerly known as MDNA55, is engineered to bind selectively to the interleukin-4 receptor, which Medicenna says is overexpressed on glioblastoma cells and in the surrounding tumour microenvironment. The drug is administered directly into the tumour via convection-enhanced delivery, a technique that bypasses the blood-brain barrier by infusing therapeutic agents under positive pressure through stereotactically placed catheters. More than 130 patients have been treated across five clinical trials, including a completed Phase 2b study in rGBM. The FDA has granted bizaxofusp both Fast Track designation and Orphan Drug status; Orphan Drug designation has also been awarded in Europe.

Fahar Merchant, President and Chief Executive of Medicenna, said the selection for an oral presentation "highlights the interest of the neuro-oncology community in the continued clinical development of bizaxofusp" and that the company would use SNO 2026 to engage with potential pharmaceutical partners.

Market landscape and regulatory context

Recurrent glioblastoma is one of the most difficult indications in oncology. Median overall survival after recurrence is typically measured in months, and no therapy has achieved regulatory approval in the recurrent setting in the major markets since bevacizumab received accelerated approval in the United States more than a decade ago, a designation that was subsequently contested on the basis of overall survival data. The absence of an approved standard of care creates both a clinical opportunity and a regulatory challenge: without a recognised comparator arm, sponsors face pressure to justify trial design choices, which is why external control arm methodology is attracting growing interest from both companies and regulators.

The FDA and EMA have issued guidance on the use of real-world data and external controls in oncology, with the FDA's Project Optimus and broader RWD frameworks offering a pathway for sponsors operating in indications where randomised control is difficult. Medicenna's propensity score-weighted external control approach is consistent with this trend, though regulators will ultimately determine whether the methodology is sufficient to support a registrational endpoint.

Medicenna is also advancing a pipeline beyond bizaxofusp, including MDNA11, a long-acting IL-2 Superkine in Phase 1/2, and MDNA113, a PD-1 x IL-2 bifunctional asset. The SNO readout will be closely watched by investors and potential partners as a signal of whether the Phase 3 design is on solid evidential footing before the company commits the capital required for a pivotal study in this high-unmet-need but historically unforgiving indication.

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