Dr. Fahar Merchant reports

MEDICENNA ANNOUNCES COMPELLING SURVIVAL BENEFIT FROM PHASE 2B STUDY OF BIZAXOFUSP IN RECURRENT GLIOBLASTOMA AT THE 28TH ANNUAL MEETING OF THE SOCIETY FOR NEUROONCOLOGY

A poster presentation and an oral summary highlighting longer-term follow-up results from Medicenna Therapeutics Corp.'s phase 2b clinical trial of bizaxofusp (formerly known as MDNA55), the company's first-in-class IL-4R targeted therapy for the treatment of patients with recurrent glioblastoma (rGBM), will be presented by Dr. Steven Brem, MD (medical director, Centre for Precision Surgery, Abramson Cancer Center, Perelman School of Medicine, University of Pennsylvania), at the Society for Neuro-Oncology (SNO) 2023 annual meeting, taking place from Nov. 15 to 19, 2023, in Vancouver, Canada.

"Bizaxofusp represents an exciting new approach by demonstrating a dose-dependent effect on the receptor of IL-4, an immuno-suppressive cytokine. Further, use of bizaxofusp as a single agent or in combination could flip the switch on glioblastoma to convert it from an immunologically cold (unresponsive) tumour to one that is responsive, using convection enhanced delivery to take the fight to the tumour. The data offers new hope for patients with glioblastoma who have few treatment options at recurrence," said Dr. Steven Brem.

"We are very encouraged by the 100-per-cent increase in survival benefit in unresectable rGBM achieved from a single treatment with bizaxofusp, even after 22 months of additional follow-up, which reinforces the robustness of the initial primary analysis," said Dr. Fahar Merchant, PhD, president and chief executive officer of Medicenna. "In conjunction with regulators, our pioneering efforts have secured us a precedent-setting phase 3 trial design in rGBM using an external control arm and are actively pursuing partnerships to further advance the bizaxofusp registrational study. Following the publication of our phase 2b results in the journal Neuro-Oncology earlier this year, it is a great privilege to be able share these updated four-year follow-up results with the medical and scientific communities at SNO 2023."

Four-year follow-up results from the phase 2b study

This multicentre, open-label, single-arm phase 2b study enrolled and treated 44 patients with rGBM following surgery or radiotherapy plus or minus adjuvant therapy or other experimental therapies. A separate analysis collected rGBM data from 81 patients who had contemporaneously received treatment at major clinical centres using current standard of care, were used to establish a matched external control arm (ECA). The blinded survival data from the matched ECA (established by matching with the bizaxofusp-treated population based on 11 different prognostic factors using propensity scoring methods) were then used as a control arm versus survival data from the phase 2b bizaxofusp trial.

The data demonstrated that a single treatment with bizaxofusp increased median overall survival (mOS) by 72 per cent compared with the ECA (12.4 months versus 7.2 months). Overall survival (OS) for bizaxofusp-treated patients increased 370 per cent at year 1 and increased more than 50 per cent at year 2. Importantly, bizaxofusp doubled mOS (14.5 months versus 7.2 months) irrespective of IL4R expression (high or low) compared with ECA. No systemic or clinically significant laboratory abnormalities were reported. treatment-related adverse events were primarily neurological or aggravation of pre-existing neurological deficits due to rGBM.

Details for the SNO 2023 poster presentation

Title:  Survival outcomes in recurrent glioblastoma (rGBM) patients treated with a single intra-tumoural administration of bizaxofusp, an IL-4R-targeting toxin, in a phase IIb trial

Presenter:  Dr. Brem, MD, University of Pennsylvania

Abstract number:  CTNI-52

Session:  Clinical trials: non-immunologic

Presentation date and time:  Friday, Nov. 17, 2023: 7:30 to 9:30 p.m. PT

Oral presentation date and time:  Friday, Nov. 17, 2023: 7:30 p.m. PT

A copy of the poster and a related slide deck will be posted after the presentation to the events and presentations page of Medicenna's website.

About Medicenna Therapeutics Corp.

Medicenna is a clinical-stage immunotherapy company focused on developing novel, highly selective versions of IL-2, IL-4 and IL-13 superkines and first-in-class class-empowered superkines.

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