Earnings release
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MEDICENNA Medicenna Reports First Quarter Fiscal 2022 Financial Results and Operational Highlights -- Phase 1/2 ABILITY Study of MDNA11 in patients with advanced solid tumors remains on track for initiation in the third quarter of calendar 2021 -- Management hosting conference call and webcast today at 8:30 AM ET -- TORONTO and HOUSTON , Aug. 13 , 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 quarter ended June 30 , 2021. All dollar amounts are expressed in Canadian currency unless otherwise noted . " We are off to a strong start in fiscal 2022 and well positioned for continued success with a steady frequency of value creating milestones expected over the coming year , " said Fahar Merchant , PhD , President and CEO of Medicenna . " We are on track to initiate our Phase 1/2 ABILITY Study of MDNA11 in calendar Q3 . We believe MDNA11's ‘ beta - only ' IL - 2 receptor selectivity provides clear differentiation compared to the ‘ pegylated not - alpha ' IL - 2 agents currently in the clinic . We aim to clinically demonstrate MDNA11's best - in - class potential through the ABILITY Study and look forward to providing a preliminary update on safety , PK / PD , and biomarker data by calendar year - end with preliminary efficacy readouts expected over the course of calendar 2022. " TM Dr. Merchant continued , “ Beyond MDNA11 , we remain in active discussions in pursuit of a partnership for MDNA55 and continue to leverage the power of our Superkine and BISKITS platforms to advance the development of additional cytokine- based immunotherapies . With funding through the end of 2022 , we are well positioned to ensure the continued advancement of these programs and our ABILITY Study , which in turn should allow us to generate value for patients and shareholders . " Program highlights for the quarter ended June 30 , 2021 , along with recent developments include : MDNA11 : IL - 2 Superkine Program ° 。 On June 23 , 2021 , Medicenna announced the submission of a clinical trial application to a Human Research Ethics Committee ( HREC ) in Australia to initiate the Phase 1/2 ABILITY Study of MDNA11 , the Company's selective , long- acting and novel 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 will begin with a monotherapy dose escalation phase 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 remains on track to start enrollment in the ABILITY Study in Australia in the third quarter of calendar 2021 , with expansion to additional sites in the US , UK , and Canada to occur thereafter . The remaining regulatory submissions and approvals for these jurisdictions remain on track for completion in calendar 2021 . Subsequent to the quarter end , Medicenna announced the peer - reviewed publication of preclinical data on MDNA109 , the Company's IL - 2 Superkine platform that forms the basis for MDNA11 . The data , which were published in Frontiers in Immunology , 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 , these findings provide external validation for the broad clinical utilization of the MDNA109 platform . MDNA55 : Recurrent Glioblastoma ( rGBM ) Program • On May 7 , 2021 , Medicenna announced the peer - reviewed publication of clinical data from the Phase 2b trial evaluating MDNA55 , an interleukin - 4 ( IL - 4 ) -guided toxin in rGBM . The data , which was published in Clinical Cancer Research , indicated that early determination of progression free survival ( PFS ) with modified RANO ( mRANO ) criteria may be a strong surrogate for overall survival ( OS ) in rGBM . This data supplements previously presented findings observed in Medicenna's proposed patient population showing an 81 % tumor control rate ( 26/32 ) based on mRANO and a median overall survival ( OS ) of 15.7 months , which represents a doubling in survival when compared to an external control arm ( median OS of 7.2 months ) . Medicenna remains in active discussions in pursuit of a partnership to facilitate MDNA55's further development and commercialization . Bifunctional SuperKine Immuno Therapies ( BiSKITS ™ ) Program 。 On April 12 , 2021 , Medicenna presented preliminary preclinical data at the 2021 American Association of Cancer Research ( AACR ) Annual Meeting supporting the immune modulating effects of MDNA19 - MDNA413 , a novel and long- acting Dual Cytokine ( DUCK Cancer ™ ) designed to simultaneously activate cancer killing immune cells while reversing the immunosuppressive TME . The Company believes the presented data demonstrate the ability of MDNA19 - MDNA413 to activate a pro - inflammatory , anti - tumor response due to its highly selective binding and signaling via the intermediate affinity IL - 2 receptor ( CD122 / CD132 ) , while simultaneously inhibiting pro - tumoral immune pathways by blocking IL4 / IL13 signaling via the Type 2 IL - 4 receptor ( IL - 4R / IL - 13Ralpha1 ) .