Benzinga | Jun 23, 2021 09:03AM EDT

Medicenna Announces Submission Of Clinical Trial Application In Australia For Phase 1/2 Study Of MDNA11

Medicenna Therapeutics Corp. ("Medicenna" or "the Company") (NASDAQ:MDNA, TSX:MDNA), a clinical stage immuno-oncology company, today announced that it has submitted a clinical trial application to a Human Research Ethics Committee (HREC) in Australia to initiate a Phase 1/2 clinical study of MDNA11, the Company's selective, long-acting and novel IL-2 super-agonist. Subject to approval by the HREC and acceptance of the Clinical Trial Notification (CTN) by Australia's Therapeutics Goods Administration (TGA), Medicenna expects to initiate this study in the third quarter of 2021. Additionally, pending successful patient recruitment, the Company intends to provide a preliminary update on safety, pharmacokinetic (PK), pharmacodynamic (PD), and biomarker data by year end.

"Submission of this dossier for HREC approval is an important milestone that keeps us on track to execute our broader clinical and corporate strategy," said Fahar Merchant, PhD, President and Chief Executive Officer of Medicenna. "We look forward to the initiation of this trial and reporting results that could support MDNA11's best-in-class potential as a "beta-only IL-2" instead of "not-alpha IL-2" agents currently in the clinic. In addition to MDNA11's first ABILITY Study (A Beta-only IL-2 ImmunoTherapY Study), we are advancing our BiSKITsTM program to identify a new a lead candidate to add to our pipeline while we advance partnering discussions around MDNA55. We are encouraged with recent progress we have made on multiple fronts and are also hopeful that a partnership for MDNA55 will be completed in the coming months. Collectively, our pipeline of opportunities leave us well positioned to achieve a steady cadence of value creating milestones as we work to address the unmet needs of patients."

The planned Phase 1/2 ABILITY Study is designed to assess the safety, PK, PD, and anti-tumor activity of various doses of intravenously administered MDNA11 in patients with advanced solid tumors. It includes both, an MDNA11 monotherapy arm as well as a combination arm designed to evaluate MDNA11 with a checkpoint inhibitor. Following its progress in Australia, Medicenna intends to expand the study to the United Kingdom, the United States and Canada.

Mann Muhsin, MD, Chief Medical Officer of Medicenna, commented, "MDNA11 has the attributes to overcome the limitations of competing IL-2 therapies and the filing of this application represents a crucial step in exploring the pan-tumor potential of MDNA11 and its ability to treat multiple tumor types spanning a wide immunogenicity spectrum. Preclinical data demonstrate MDNA11's ability to selectively stimulate durable expansion of cancer-killing immune cells without the unwanted adverse events typically seen with IL-2. Our Phase 1/2 study is designed to clinically validate these results, as it will include safety and PK/PD assessments as well as collection of biomarker data from paired pre- and on-treatment tumor biopsies. The preliminary efficacy readout from the monotherapy arm is expected in 2022 and most notably will evaluate MDNA11's anti-tumor activity in expansion cohorts comprised of subjects with metastatic melanoma and advanced renal cell carcinoma, tumor types that are known to respond to IL-2 therapy but have yet to show comparable responses with the not-alpha IL-2s."