Medicenna BioPharma, a wholly owned subsidiary of Medicenna Therapeutics Corp., a publicly listed clinical stage immuno-oncology company, announced that it has treated the first patient in its phase 2b clinical trial of MDNA55, the company's lead candidate. MDNA55 is being developed for the treatment of recurrent glioblastoma (rGB), the most common and uniformly fatal form of brain cancer.
"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," said Dr. Fahar Merchant, chairman and chief executive officer of Medicenna. "We are pleased to be working with leading neuro-surgical centers in the US as we explore the benefits of MDNA55 for the treatment of rGB and other types of brain cancer."
MDNA55 is a targeted form of immunotherapy designed to purge tumor cells and adjacent immunosuppressive cells in the tumor microenvironment that over-express the interleukin-4 receptor (IL4R), which is common in a majority of patients with rGB. By directly eliminating tumor cells and boosting a therapeutic immune response in rGB patients, MDNA55 provides a two-pronged approach to treat brain cancer patients.
"We are delighted to have included the first patient in this important study," said Dr. Andrew Brenner, Clinical Investigator, Institute of Drug Development at UT Health San Antonio Cancer Center. "The state-of-the-art neuro-surgical and imaging techniques to optimize drug delivery together with MDNA55, which simultaneously targets killing of cancer cells and boosts the immune system's response against the tumor, has the potential to alter the treatment paradigm for brain cancer. Our participation in this trial puts Cancer Therapy and Research Center in San Antonio at the forefront of efforts to find new treatments for this terrible disease," added Dr. John Floyd, Neurosurgeon and Interim Chair, Department of Neurological Surgery.
The multi-center, single-arm, open-label, Phase 2 investigation of MDNA55 (ClinicalTrials.gov identifier: NCT02226965) will enroll approximately 43 adult patients with glioblastoma who have progressed or recurred following previous therapy. Patients will be administered MDNA55 by a single intra-tumoral infusion using convection enhanced delivery (CED), a minimally invasive technique used to by-pass the blood brain barrier. The use of precision image guided CED is anticipated to deliver the drug to the tumor and its microenvironment while dramatically reducing systemic side effects.
The primary endpoint is overall response rate (ORR), assessed by magnetic resonance imaging using the Revised Assessment in Neuro-Oncology (RANO) criteria. Secondary outcome measures include progression-free survival, overall survival, and exploratory predictors of outcome assessed by IL4R expression in archived tumor biopsies.
The study will be conducted in approximately ten sites in the United States. Patient enrolment is expected to be completed before the end of 2017 with top-line results anticipated in the first half of 2018.
MDNA55 is a targeted form of immunotherapy designed to purge tumor cells and adjacent immunosuppressive cells in the tumor microenvironment that over-express the interleukin-4 receptor (IL4R), which is common in a majority of patients with glioblastoma and other aggressive forms of brain cancer. By directly eliminating tumor cells and boosting a therapeutic immune response, MDNA55 provides a two-pronged approach to treat brain cancer patients. MDNA55 has received Fast Track Designation from the FDA and Orphan Drug Status from both the FDA and EMA. Earlier results from three Phase 1 and 2a clinical trials in 66 patients with glioblastoma showed potent anti-tumor effects without drug-related systemic toxicity in the majority of patients.