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MEDICENNA -- Medicenna Reports Second Quarter Fiscal 2022 Financial Results and Operational Highlights Phase 1/2 ABILITY Study of MDNA11 on track for preliminary data updates in calendar 2021 and mid - calendar 2022 -- Management hosting conference call and webcast today at 8:30 am ET -- TORONTO and HOUSTON , Nov. 12 , 2021 ( GLOBE NEWSWIRE ) Medicenna Therapeutics Corp. ( " Medicenna " or " the Company " ) ( NASDAQ : MDNA TSX : MDNA ) , a clinical stage immuno - oncology company , today provided a business update and announced its financial results and operational highlights for the quarter ended September 30 , 2021. All dollar amounts are in Canadian currency unless otherwise noted . " Our accomplishments over the past few months have laid the foundation towards achieving key milestones that intend to provide the first set of human data of MDNA11 with the aim to show differentiated and potentially superior clinical activity of our lead IL - 2 Superkine asset , ” said Fahar Merchant , PhD , President and CEO of Medicenna . " We recently began dosing patients in the ABILITY study of MDNA11 in Australia and received IND clearance to expand to sites in the United States . We believe that this will position us to present a key safety and biomarker data update late in calendar 2021 and initial efficacy data in mid - calendar 2022. Through these updates , we hope to provide clinical validation of the non - human primate data which demonstrated the advantages of MDNA11's ' beta - only ' approach of stimulating cancer fighting T - cells without the toxic side effects of native IL - 2 . " Dr. Merchant continued , " Alongside our progress with MDNA11 , the MDNA55 Phase 3 clinical trial hybrid design was highlighted in a peer - reviewed manuscript published in The Lancet Oncology and we continue to engage in active discussions in pursuit of a strategic partnership for this asset . We are particularly enthusiastic about advancing our preclinical assets derived from our BISKITS and Superkine platforms , and expect to declare a lead candidate by calendar year end . In concert with the progress of our Phase 1/2 MDNA11 ABILITY study , our programs are designed to fuel sustained growth of our pipeline as we endeavor to advance innovative cytokine - based therapies for patients with unmet medical needs . " Program highlights for the quarter ended September 30 , 2021 , along with recent developments include : MDNA11 : IL - 2 Superkine Program • On September 14 , 2021 , Medicenna announced the initiation of subject dosing in the Phase 1/2 ABILITY Study of MDNA11 , the Company's " beta - only " and long - acting IL - 2 super - agonist . The study is designed to assess the safety , pharmacokinetics ( PK ) , pharmacodynamics ( PD ) , and anti - tumor activity of MDNA11 in patients with advanced solid tumors . It includes a monotherapy dose escalation phase , which will be followed by an expansion phase for both the MDNA11 monotherapy arm at the recommended phase 2 dose ( RP2D ) , and a combination arm designed to evaluate MDNA11 with a checkpoint inhibitor . 。 Medicenna continues to advance the ABILITY study at trial sites in Australia and , subsequent to the quarter end , received IND clearance from the U.S. Food and Drug Administration to expand the trial to sites in the United States . The Company also intends to expand the ABILITY study to additional sites in the UK and Canada and expects to complete the remaining regulatory submissions for these jurisdictions in calendar 2021 . Subsequent to the quarter end , Medicenna announced the presentation of new preclinical data from murine and IND- enabling non - human primate ( NHP ) studies of MDNA11 at the AACR - NCI - EORTC Virtual International Conference On Molecular Targets and Cancer Therapeutics ( Triple Meeting ) . Data from NHP studies showed that MDNA11 did not lead to the safety issues typically associated with IL - 2 and preferentially induced durable proliferation and expansion of anti- cancer immune cells with limited stimulation of pro - tumor Treg cells . In a murine cancer model , MDNA11 alone or in combination with a PD - 1 checkpoint inhibitor resulted in 100 % tumor control and long - term protection against tumor re- challenge by inducing antigen - specific CD8 + T cells . ⚫ Results based on independent research were published in a peer - reviewed publication in Frontiers in Immunology featuring data on MDNA109 , the Company's IL - 2 Superkine platform that forms the basis for MDNA11 . The data highlight the ability of an MDNA109 - armed oncolytic virus to reverse immunosuppressive tumor microenvironments ( TME ) and its potential to treat immunologically “ cold ” tumors such as pancreatic cancer . Collectively , we believe these findings provide external validation of the versatility of our Superkine platform . MDNA55 : Empowered IL - 4 Superkine Program In October 2021 , the design of the planned open - label hybrid Phase 3 trial of MDNA55 in recurrent glioblastoma ( rGBM ) was highlighted in a peer - reviewed manuscript published in The Lancet Oncology , and in an oral presentation at the Society for Neuro - Oncology and American Society of Clinical Oncology's First Annual Conference on CNS Clinical Trials . Unlike conventional randomized control trials , the hybrid trial design will reduce the overall number of patients 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 in active discussions in pursuit of a partnership to facilitate MDNA55's