Increased cash balance to $37 million following a $20 million investment by RA Capital extending runway into mid-2026 MDNA11 continues to exhibit compelling deep and durable single agent activity and best-in-class potential relative to other IL-2 therapies in clinical development Results presented at the Annual Meeting of the AACR showed single agent MDNA11 response rate of 29% (4/14) in patients with checkpoint resistant tumors Combination dose escalation with pembrolizumab (KEYTRUDA) continues to enroll patients at the MDNA11 monotherapy expansion dose (90 µg/kg, Q2W) having cleared safety at 60 µg/kg, Q2W Approval of Clinical Trial Application by the European Medicines Agency expands the ABILITY-1 study of MDNA11 to Cancer Centers in the EU Updated MDNA11 monotherapy expansion and combination escalation results to be presented at medical conferences in H2 of 2024 TORONTO and HOUSTON, June 27, 2024 (GLOBE NEWSWIRE) -- Medicenna Therapeutics Corp. ("Medicenna" or the "Company") (TSX:MDNA, OTCQB:MDNAF), a clinical-stage immunotherapy company focused on the development of Superkines, today reported financial results and corporate highlights for the fiscal year ended March 31, 2024, as well as anticipated corporate milestones. "Over the past year, we have continued to demonstrate best-in-class potential of MDNA11, having shown durable single-agent efficacy in end-stage cancer patients who have failed immunotherapies while maintaining an acceptable safety profile," said Fahar Merchant, Ph.D., President and CEO of Medicenna. "We are encouraged by the 29% response rate observed in the study to date, including durable complete regression of target and non-target lesions in a pancreatic cancer patient who remains in remission and a melanoma patient that continues to show durable complete response of the target lesions. On the back of these data, we are delighted with the recent financial backing by RA Capital Management, which has strengthened our balance sheet by $20 million, extending our cash runway into mid-2026. We are also pleased to see acceptable safety profile of MDNA11 in combination with pembrolizumab, which continues to enroll patients at the higher dose used in the MDNA11 monotherapy expansion arm as well as the recent approval by EMA of our application to expand the ABILITY-1 study in Europe. We look forward to sharing new clinical data from the monotherapy dose expansion as well as the combination arms of the study at medical conferences during the second half of 2024." Program highlights for the fiscal year ended March 31, 2024, along with recent developments, include: MDNA11: IL-2 Superkine Program Clinical activity highlights include: Deep and Durable Anti-tumor Activity with Single-Agent MDNA11 29% response rate (N=4/14) and 50% clinical benefit rate (4 patients with partial responses, 3 patients with stable disease > 24 weeks) in high-dose phase 2 eligible patients who failed checkpoint inhibitor therapy A pancreatic cancer patient with 100% regression of target and non-target lesions for over 104 weeks and continues to show remission 4 months after stopping treatment A melanoma patient who is continuing on MDNA11 treatment shows 100% regression of target lesions with continued regression of non-target lesions 2 of 2 MSI-High patients and 2 of 4 evaluable dose expansion patients have had a partial response Previously reported patients with partial responses and stable disease continue on the study further supporting the durability of MDNA11 The monotherapy expansion arm is enrolling patients with metastatic melanoma, non-melanoma skin cancers and MSI-H/dMMR tumors. Combination escalation arm of the ABILITY-1 study is enrolling patients with advanced solid tumors who progressed following earlier lines of treatment. Monotherapy: Acceptable Safety Profile Complete Phase 1 monotherapy dose escalation data was presented and affirmed that MDNA11 has an acceptable safety profile. No dose limiting toxicity (DLT) was reported with no evidence of vascular leak syndrome (VLS). Vast majority (95 %) of treatment-related adverse events (TRAEs) were of grade 1-2 and resolved within 48 hours; grade 3 TRAEs mainly constituted asymptomatic transient LFT elevations; no grade 4 or 5 events were reported. Repeat administration of MDNA11 at the target doses showed further improvement in tolerability. Monotherapy: Pharmacodynamic Analysis Showed Potent and Durable Systemic Immune Activation Significant increases in stemness, central and effector memory and markers of enhanced effector function in circulating CD8+ T and NK cells, all of which are critical for achieving meaningful and durable anti-cancer response. Analysis of gene expression signatures from pre-treatment and on-treatment paired biopsies show that cancer promoting pathways were degraded while immune-related pathways against cancer cells were enhanced following MDNA11 treatment. Combination with KEYTRUDA®: Enrolling in Cohort 2 in the Absence of DLTs in ...