Benzinga | Oct 26, 2020 07:08AM EDT

Medicenna Highlights Presentation Of Late Breaking Abstract Updating Results From Phase 2b Recurrent GBM Trial At 36th EORTC-NCI-AACR Meeting

-- Amongst an all-comer population, a single treatment with MDNA55 resulted in at least 100% increase in both 12 month progression free survival (PFS-12 of 27% versus 2 to 10%) and 2-year survival (OS-24 of 20% vs 5 to10%) when compared to what is achieved with approved therapies



-- In a subset of all-comer patients treated with transient low dose bevacizumab, to reduce steroid use, median survival (mOS) was 21.8 months and OS-24 was 44%

TORONTO and HOUSTON, Oct. 26, 2020 (GLOBE NEWSWIRE) -- Medicenna Therapeutics Corp. ("Medicenna" or "the Company") (NASDAQ:MDNA, TSX:MDNA), a clinical stage immuno-oncology company, today announced a Late Breaking Abstract poster presentation of updated clinical data from the Company's Phase 2b recurrent glioblastoma ("rGBM") trial at the 36th Annual EORTC-NCI-AACR ("ENA") Symposium on Molecular Targets and Cancer Therapeutics.

Fahar Merchant, PhD, President and Chief Executive Officer of Medicenna, commented, "The updated data presented at the ENA meeting continue to affirm our belief that MDNA55 is a superior treatment option for improved survival and tumor control in difficult to treat rGBM patients. We are continuing to see marked increases in overall and progression-free survival after long term follow-up when compared to approved therapies. These results, combined with FDA's groundbreaking support for a landmark registration trial allowing use of an external control in two-thirds of the control arm, could further bolster our efforts to execute on a partnership strategy and expedite MDNA55's potential to address an urgent unmet medical need that has plagued the global brain tumor community for four decades."

The poster presentation updated long-term survival results from the Phase 2b trial evaluating MDNA55, an interleukin-4 (IL-4)-guided toxin, as a treatment for rGBM, the most common and uniformly fatal form of brain cancer. The new results indicate the potential benefit of including transient low dose Avastin(r) treatment with MDNA55. Enrolled patients had limited treatment options and poor prognostic factors such as non-resectable tumors at first or second relapse, de-novo GBM at initial diagnosis and lack of IDH1/2 mutations.

Highlights from the poster include updated results following a longer follow-up duration and new data based on transient low-dose use of bevacizumab:

* Data from all trial participants show that a single MDNA55 treatment led to a mOS of 11.9 months (expected 6-9 months) which is comparable to earlier reported mOS of 11.6 months, an OS-24 of 20% (expected 0-10%), and a PFS-12 of 27% (expected 2-10%).

* In Medicenna's proposed patient population, mOS was 14.0 months (comparable to mOS of 15 months reported earlier), OS-24 was 20%, and PFS-12 was 24%. 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.

* Unmethylated MGMT promoter affects more than 50% of GBM patients and is associated with treatment resistance and poorer survival outcomes. However, MGMT status did not negatively affect MDNA55 treatment. In the proposed population (N=17), mOS was 14.9 months with an OS-24 of 22%.

* Following MDNA55 treatment, transient (median of 3 cycles) low dose (5 mg/Kg q2w or 7.5 mg/Kg q3w) administration of Avastin(r), used for symptom control and steroid sparring in patients receiving high concentrations of MDNA55, further improved patient survival. Amongst all comers (N=9) and the proposed population (N=8), mOS was 21.8 months and 18.6 months and OS-24 was of 44% and 38%, respectively.

The electronic ENA poster, titled "MDNA55, a Locally Administered IL4 Guided Toxin for Targeted Treatment of Recurrent Glioblastoma Shows Long Term Survival Benefit", was presented by Dr. John Sampson, MD, PhD, MHSc, MBA, Robert H. and Gloria Wilkins Distinguished Professor of Neurosurgery at Duke University School of Medicine. The poster was part of the ENA Meeting's Late Breaking Poster session. A copy of the electronic poster will be posted to the "Events and Presentations" page of Medicenna's website following the conference.