On June 26, 2019 Medicenna Therapeutics Corp. ("Medicenna" or the "Company") (TSX: MDNA;OTCQB: MDNAF), a clinical stage immuno-oncology company, is reported new data on MDNA55 was published in the March 2019 issue of the journal Immunotherapy (Press release, Medicenna Therapeutics, JUN 26, 2019, View Source [SID1234537289]). The authors of the publication entitled "Combination immunotherapy with IL-4- Pseudomonas exotoxin and IFN-α and IFN-γ mediate synergistic antitumor effects in vitro and in a mouse model of human ovarian cancer", are investigators in different branches of the National Institutes of Health (NIH) and FDA’s Center for Biologics Evaluation & Research.
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In the published pre-clinical data, MDNA55 (IL-4 fused to Pseudomonas exotoxin) was shown to effectively target and kill ovarian cancer cells overexpressing the IL-4 receptor (IL4R), consistent with previous data showing the antitumor effect of MDNA55. New results have now shown that MDNA55, when combined with approved drugs called interferons (IFN-α and IFN-γ), act in a highly synergistic fashion to kill tumor cells and increase survival in an aggressive mouse model of metastatic ovarian cancer without causing damage to vital organs. These data suggest that this novel combination could provide a unique and effective approach to treating ovarian cancer.
Ovarian cancer is the seventh most common cancer in women worldwide with over 250,000 new cases diagnosed annually. Ovarian cancer is a difficult and trying disease where more than half of the patients treated with conventional therapy simply do not respond. Because it is most often diagnosed in its advanced stage, the prognosis for women with ovarian cancer has been very poor. Historical progression-free survival in ovarian cancer is 10 to 12 months for first-line treatment and 6 to 8 months for second-line treatment. The IL4R is known to be expressed in 60% of patients with ovarian cancer.
IL-4-Pseudomonas exotoxin was developed by Dr. Raj Puri (a co-author of the publication) at the USFDA and previously licensed to Medicenna and named MDNA55, a first-in-class, fusion cytotoxin that specifically targets the IL4R which is over-expressed by 20 different cancers affecting more than a million cancer patients every year. To date MDNA55 has been used to treat over 130 patients in multiple clinical trials, including over 110 patients with recurrent Glioblastoma (rGBM), building a significant safety profile, evidence of anti-tumor effect and mechanistic dataset in patients with the most aggressive form of brain cancer. MDNA55 has been the subject of a recently completed Phase 2b open-label study in patients with rGBM at first or second relapse. Promising interim top-line results from the rGBM study were announced last week.