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MEDICENNA Medicenna Reports Fiscal Year 2021 Financial Results and Operational Highlights -- Management hosting conference call and webcast today at 8:30 AM ET -- TORONTO and HOUSTON , May 28 , 2021 ( GLOBE NEWSWIRE ) Medicenna Therapeutics Corp. ( " Medicenna " or " the Company " ) ( NASDAQ : MDNA TSX : MDNA ) , a clinical stage immuno - oncology company , today announced its financial results and operational highlights for the fiscal year ended March 31 , 2021. All dollar amounts are expressed in Canadian currency unless otherwise noted . " The strong momentum we have generated over the past year leaves us poised to achieve key milestones that will lay a solid foundation for expansion of our clinical - stage pipeline , " said Fahar Merchant , PhD , President and CEO of Medicenna . " We have recently added significant talent , expertise , and depth to our management team through the appointments of industry veterans and immuno - oncology experts Kevin Moulder , PhD and Mann Muhsin , MD as our CSO and CMO , respectively . Our ability to recruit such ideal candidates to these positions was due in large part to our innovative preclinical assets and robust clinical data set demonstrating the best - in - class potential of our Superkine platform . " Dr. Merchant continued , " Looking ahead , we will work towards the advancement of MDNA11 into the clinic in calendar Q3 and the selection of a lead candidate from our BISKITS ™ program by the end of calendar 2021. We are excited for the fiscal year ahead and believe we are well positioned for sustained growth with multiple upcoming catalysts with cash runway into late 2022. " Program highlights for the year ended March 31 , 2021 , along with recent developments include : MDNA11 : IL - 2 Superkine Program • On May 29 , 2020 , Medicenna announced the presentation of data at the 2020 American Society of Clinical Oncology ( ASCO ) virtual meeting related to MDNA11 , the Company's long - acting IL - 2 super - agonist . Non - human primate data demonstrated that MDNA11 could induce an up to 10 - fold expansion in cancer fighting immune cells without : ( a ) generating anti - drug antibodies , ( b ) causing hypotension associated with vascular leak syndrome , ( c ) inducing cytokine release syndrome , or ( d ) causing other undesirable immune - mediated adverse events . Further , results showed durable tumor control for over 200 days and a strong immune memory response in a murine colon cancer model . ⚫ On October 26 , 2020 , Medicenna announced a poster presentation at the 32nd EORTC - NCI - AACR ( ENA ) Symposium on Molecular Targets and Cancer Therapeutics . The poster highlighted preclinical studies evaluating MDNA11 that supports its potent therapeutic efficacy as a monotherapy agent in multiple tumor models . 。 On November 4 , 2020 , Medicenna held a Scientific Advice Meeting for MDNA11 ( similar to a pre - IND meeting ) with the United Kingdom ( UK ) Medicines and Healthcare products Regulatory Agency ( MHRA ) . During the meeting , the MHRA confirmed that the Company's CMC , pre - clinical and Phase 1 / 2a clinical plans were appropriate for submission of an Investigational Medical Product Dossier ( IMPD ) for a first in human study with MDNA11 in the UK . We are currently in the process of advancing MDNA11 into a Phase 1 / 2a clinical trial in Australia and the UK . Submission of the Australian regulatory package is expected by the end of June 2021 , and initiation of the trial is expected in the third quarter of calendar 2021. Initiating the Phase 1 / 2a trial outside of the U.S. will allow Medicenna to begin dose escalation studies at doses that are closer to therapeutically effective doses and take advantage of an increased prevalence of checkpoint inhibitor naive patients . The company plans to expand the trial to the U.S. and Canada after completion of the study's dose escalation portion , subject to discussions with the respective regulatory agencies . ⚫ On March 25 , 2021 , Medicenna presented new preclinical data on MDNA11 during an oral presentation at the virtual Cytokine - Based Cancer Immunotherapies Summit . Data featured in the presentation showed that treatment with MDNA11 alone or in combination with anti - PD - 1 therapy resulted in 100 % tumor growth inhibition in a murine MC38 tumor model whereas tumor growth in this model was not effectively controlled by anti - PD - 1 monotherapy . MDNA55 : Recurrent Glioblastoma Program ° ⚫ On October 15 , 2020 , Medicenna provided an update on the clinical development of MDNA55 , an interleukin - 4 ( IL - 4 ) - guided toxin targeting recurrent glioblastoma ( rGBM ) , the most common and uniformly fatal form of brain cancer . Following an End of Phase 2 Meeting with the United States Food and Drug Administration ( FDA ) , the agency agreed that Medicenna could conduct an innovative open - label hybrid Phase 3 trial that allows use of a substantial number of subjects ( two - thirds ) from a matched external control arm to support regulatory approval of MDNA55 for rGBM . The FDA also expressed their willingness to consider an interim analysis of the trial if certain criteria are met . Unlike conventional randomized control trials , the hybrid trial design will reduce the overall number of subjects needed in the study to achieve the primary endpoint as well as potentially reduce the cost and timelines associated with completing the trial . Medicenna is currently pursuing a partnership strategy to facilitate MDNA55's further development and commercialization . Throughout fiscal year 2021 , Medicenna presented updated data from the Phase 2b trial evaluating MDNA55 in rGBM subjects . Data from the most recent presentation at the 2nd Annual Glioblastoma Drug Development Summit in December showed that amongst an all - comer population , a single treatment with MDNA55 resulted in a greater than