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     133  0 Kommentare Medicenna Reports First Quarter Fiscal 2021 Financial Results and Operational Highlights - Seite 2

    Program highlights for the quarter ended June 30, 2020, along with recent developments, include:

    MDNA55: Recurrent Glioblastoma Program:

    • In July, 2020 Medicenna submitted its EOP2 meeting package to the FDA and feedback from the FDA is expected in calendar Q4 2020 following this meeting which has been scheduled for 29th September, 2020.
       
    • On May 29, 2020, Medicenna announced that Dr. John Sampson presented new data and analyses from a Phase 2b clinical trial of MDNA55 in rGBM patients at the 2020 ASCO virtual meeting. Results showed a 126% increase in median overall survival (“mOS”) in Medicenna’s proposed patient population (mOS = 15.8 months) compared to an eligibility matched synthetic control arm (mOS = 7.0 months). The proposed patient population included all MDNA55-treated trial participants with high IL4R expression and participants with low IL4R expression that received a high dose of MDNA55 treatment.

    MDNA11: IL-2 Superkine Program

    • On May 29, 2020 Medicenna announced presentation of data at the 2020 ASCO virtual meeting related to MDNA11, the Company’s long-acting IL-2 super-agonist. Non-human primate data demonstrated that MDNA11 could induce 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) cytokine storms, or (d) other undesirable immune mediated side effects. Further, monotherapy with MDNA11 treatment led to durable tumor control for over 200 days and a strong immune memory response in a murine colon cancer model.

    Operational Highlights

    • On July 29, 2020 Medicenna received confirmation that its shares were DTC eligible, allowing non-Canadian investors to easily trade the Company’s stock through the broker of their choice.
       
    • On April 15, 2020 Medicenna announced that agents exercised their over-allotment option in connection with the Company’s public offering of common shares completed on March 17, 2020. As a result of the exercise of this over-allotment option, Medicenna received additional gross proceeds of approximately $5.2M for total gross proceeds of $40.25M, which the Company will use to advance its IL-2 superkine program.

    Upcoming Milestones

    Medicenna will focus on achieving the following milestones in the upcoming quarters:

    • Discuss the development path for MDNA55 for rGBM with the FDA at the EOP2 meeting scheduled for 29th September, 2020. Medicenna expects that feedback from this meeting will be available in Q4 of calendar 2020.
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    Medicenna Reports First Quarter Fiscal 2021 Financial Results and Operational Highlights - Seite 2  - Further advances in recurrent glioblastoma program including submission of End of Phase 2 (“EOP2”) meeting package for MDNA55  - EOP2 meeting scheduled for 29th September, 2020 with FDA input expected in calendar Q4 2020   - Presented new …

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