Medicenna Therapeutics Corp. (“Medicenna” or the “Company”) , a clinical stage immuno-oncology company, is pleased to announce that it has completed enrolment in the Phase 2b clinical study of MDNA55 for the treatment of recurrent glioblastoma (rGBM), the most common and uniformly fatal form of brain cancer.
“The completion of patient enrolment with our flagship clinical asset is a significant milestone for Medicenna and we look forward to reporting interim top-line data from this trial in June 2019.” said Dr. Fahar Merchant, Chairman, President and CEO, “Glioblastoma is a devastating disease and it is particularly aggressive in patients overexpressing the IL4 receptor (IL4R), a biomarker that is specifically targeted by MDNA55. The interim results we presented in February 2019 demonstrated that a single low dose treatment with MDNA55 was able to extend survival by 2-fold to 15.2 months in rGBM patients expressing the IL4R when compared to expected survival of 6 to 8 months. We would like to thank our shareholders for their patience, the Cancer Prevention and Research Institute of Texas (CPRIT) for a generous grant, investigators, clinical sites, patients and their families for their continued support to bring MDNA55 to patients who need it the most.”
The Company is now evaluating data from 25 patients with rGBM treated at the high dose and assessing the impact of IL4R expression on survival outcomes as well as tumor response. Interim top-line results for all patients will be announced this quarter. To date MDNA55 has been used to treat more than 130 patients in multiple clinical trials, including more than 110 patients with rGBM, building a significant safety profile, evidence of anti-tumor effect and mechanistic dataset. Medicenna expects multiple presentations of clinical results at relevant conferences this year and provide updates following meetings with regulatory agencies regarding future path to commercialization of MDNA55.
MDNA55, an IL4R directed toxin, has been the subject of a Phase 2b open-label study in up to 52 patients with glioblastoma (GBM) at first or second relapse. In the study, investigators administered MDNA55 only once directly into the brain tumor using a technique known as Convection Enhanced Delivery (CED). CED allows precision delivery of MDNA55 directly into the tumor tissue and the surrounding healthy brain containing infiltrative tumor cells, while avoiding exposure to the rest of the body. Retrospective analysis of GBM tissue obtained at first diagnosis is performed by immunohistochemistry for IL-4Ra expression. Biopsy samples are categorized based on IL4Rα expression levels and compared against survival outcomes.