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Medicenna Reports Third Quarter Fiscal 2021 Financial Results and Operational Highlights TORONTO and HOUSTON , Feb. 12 , 2021 ( GLOBE NEWSWIRE ) Medicenna Therapeutics Corp. ( " Medicenna " or " Company " ) ( NASDAQ : MDNA , TSX : MDNA ) , a clinical stage immuno - oncology company , today announced its financial results and operational highlights for the quarter ended December 31 , 2020. All dollar amounts are expressed in Canadian currency unless otherwise noted . " Last quarter we achieved key regulatory milestones across our pipeline that position us for what we expect to be a catalyst rich calendar year , " said Dr. Fahar Merchant , Chairman , President and Chief Executive Officer of Medicenna . " The FDA's acceptance of our precedent - setting registration trial design for MDNA55 in recurrent glioblastoma we believe has bolstered our pursuit of a partnership for this due to the strength of our clinical data set and the high unmet need that exists for this uniformly fatal brain cancer . We also received positive feedback from the UK's MHRA on our plans for a Phase 1/2 clinical trial of MDNA11 , which is supported by preclinical data demonstrating the long - acting IL - 2 Superkine's best - in - class potential . " Dr. Merchant continued , “ Each of these accomplishments was enabled by the scientific and clinical progress we made throughout the past calendar year , which was facilitated by our team's ability to successfully navigate the challenges of the pandemic and execute on our goals . Moving forward , we will seek to continue to strategically adapt to these challenges as we work to bring MDNA11 to the clinic in mid - calendar 2021 , pursue a partnership strategy for MDNA55 , and position the Company for continued growth . " Program highlights for the quarter ended December 31 , 2020 , along with recent developments , include : MDNA55 : Recurrent Glioblastoma Program : 。 On December 11 , 2020 Medicenna hosted a key opinion leader ( KOL ) call and 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 . The call featured a discussion by KOLS on the design and advantages of the planned Phase 3 registrational trial of MDNA55 in rGBM . The U.S. Food and Drug Administration ( FDA ) has agreed that the trial can have an innovative open label hybrid design that allows use of a substantial number of subjects ( 2/3 ) from a matched external control arm and has also expressed a willingness to consider an interim analysis if certain criteria are met . Compared to conventional randomized control trials , the hybrid trial design will reduce costs , timelines , and the number of subjects needed to achieve the primary endpoint . KOLs also discussed the keys to the FDA's acceptance of this precedent - setting trial design , which include the significant unmet medical need in rGBM and the large effect size exhibited in the MDNA55 Phase 2b study . A replay of the call , which featured Dr. David Reardon ( Harvard Medical School ) , Dr. John Sampson ( Duke School of Medicine ) , Dr. Ruthie Davi ( Acorn Al ) , and Dr. Amy McKee ( Parexel ) can be found here . 。 On October 15 , 2020 Medicenna announced the completion of a positive End of Phase 2 meeting with the FDA regarding the regulatory pathway for MDNA55 . Following the meeting , the Company was authorized by the FDA to proceed with the hybrid trial design highlighted during the KOL call discussed above . Medicenna is currently pursuing a partnership strategy to facilitate MDNA55's further development . ⚫ On December 9 , 2020 Medicenna presented updated data from the Phase 2b trial evaluating MDNA55 in rGBM patients at the 2nd Annual Glioblastoma Drug Development Summit . Amongst an all - comer population , a single treatment with MDNA55 resulted in a greater than 100 % increase in 2 - year survival ( OS - 24 of 22 % vs. 10 % ; calculated from date of relapse ) compared to an eligibility matched external control arm . A single MDNA55 treatment also improved 12 - month progression free survival by more than 100 % compared to what is achieved with approved therapies ( PFS - 12 of 27 % vs. 2 to 10 % ) . Further , a subset of patients treated with low dose bevacizumab to reduce steroid use saw improvements in median survival ( mOS ) and OS - 24 compared to the all - comer population ( mOS of 21.8 months vs. 11.9 months ; OS - 24 of 44 % vs. 20 % ; calculated from time of MDNA55 treatment ) . MDNA11 : IL - 2 Superkine Program ⚫ 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 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 . Submission of the IMPD and initiation of the trial is expected in mid - calendar 2021. Initiating the Phase 1 / 2a trial outside of the U.S. will allow Medicenna to begin dose escalation studies at a higher dose and take advantage of an increased prevalence of checkpoint inhibitor naive patients . The company plans to expand the trial to the U.S. after completion of the study's dose escalation portion . ⚫ On October 26 , 2020 Medicenna announced a poster presentation at the 32nd ENA Symposium on Molecular Targets and Cancer Therapeutics . The poster highlighted preclinical studies evaluating MDNA11 and a long - acting bispecific IL- 2 / IL - 13 Superkine designed to simultaneously activate cancer killing immune cells while reversing anti - inflammatory