Medicenna Shows Bizaxofusp Improves Survival in Recurrent Glioblastoma at 2024 ASCO

Medicenna Therapeutics Corp. has released promising data from its Phase 2b clinical trial investigating bizaxofusp, also known as MDNA55, in patients with unresectable recurrent glioblastoma (rGBM). The results were presented at the 2024 Annual Meeting of the American Society of Clinical Oncology (ASCO) in Chicago.

Bizaxofusp, an Empowered Superkine targeting the IL-4 receptor (IL-4R), demonstrated a significant survival benefit. A single treatment with the drug increased median overall survival (mOS) to 13.5 months compared to 7.2 months for a matched external control group, marking an 88% improvement (p=0.009). Additionally, the risk of death was reduced by nearly half (hazard ratio: 0.54, 95% confidence interval: 0.34-0.83). This survival benefit was observed regardless of IL-4R expression levels, broadening the potential applicability of the treatment.

Dr. Fahar Merchant, President and CEO of Medicenna, highlighted the significance of these findings, emphasizing the potential for bizaxofusp to serve as a novel therapeutic approach for rGBM, a severe type of brain cancer lacking approved standard treatments. The updated Phase 2b data, which now include a larger patient pool, have shown that improvement in survival with bizaxofusp is statistically significant when compared to a well-balanced external control arm. Medicenna is leveraging these findings to seek Breakthrough Therapy Designation and align with the European Medicines Agency (EMA) for a Phase 3 trial.

The Phase 2b study involved 44 patients with rGBM who had undergone surgery or radiotherapy with or without additional therapies. An external control arm was established using data from 81 rGBM patients treated at major clinical centers. This control arm was matched with the bizaxofusp-treated group based on 11 prognostic factors, including IL-4R expression levels. The updated analysis excluded IL-4R expression as a prognostic factor, thus expanding the number of patients eligible for analysis.

In addition to the overall survival benefits, the study showed that patients who achieved tumor control following bizaxofusp treatment had significantly longer median overall survival (16.7 months) compared to those without tumor control (8.5 months, p=0.017). This correlation between tumor control and improved survival is noteworthy as previous therapies for rGBM have not established such a connection.

Bizaxofusp has undergone evaluation in five clinical trials involving over 130 patients, including the Phase 2b study for rGBM. The results of these studies have been promising, leading to the drug receiving FastTrack and Orphan Drug status from the FDA and EMA. Medicenna aims to conduct the Phase 3 LIGHT trial, which will involve high-dose bizaxofusp treatment for rGBM patients, and is actively seeking partnerships for this endeavor.

Medicenna is a clinical-stage immunotherapy company developing novel Superkines, including IL-2, IL-4, and IL-13 variants, designed to enhance immune responses against cancer. Besides bizaxofusp, the company is also developing MDNA11, a next-generation IL-2 Superkine, and early-stage programs like BiSKITs™ and T-MASK™ aimed at improving treatment for immunologically "cold" tumors.

These promising results for bizaxofusp bring hope for better treatment options for rGBM patients and mark a significant step forward in Medicenna's mission to develop effective immunotherapies.