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New data from the Phase 1 dose-escalation and evaluation portion of the trial will be presented at the Society of Immunotherapy for Cancer (SITC) Annual Meeting on November 4, 2023
Company expects to report initial results from both the monotherapy and combination arms of the Phase 2 dose expansion study in H1 2024
TORONTO and HOUSTON, Oct. 25, 2023 (GLOBE NEWSWIRE) -- Medicenna Therapeutics Corp. ("Medicenna" or the "Company") (NASDAQ:MDNA, TSX:MDNA), a clinical-stage immunotherapy company focused on the development of novel Superkines, today announced dosing of the first patient in the Phase 2 monotherapy dose expansion portion of the Phase 1/2 ABILITY (A Beta-only IL-2 ImmunoTherapY) study evaluating MDNA11, a long-acting, beta-only interleukin-2 (IL-2) super-agonist.
"We are excited to dose our first patient in Phase 2 clinical trial as we build critical momentum for MDNA11, a potentially best-in-class, next-generation IL-2 super-agonist for the treatment of advanced solid tumors," said Fahar Merchant, Ph.D., President and CEO of Medicenna. "Dosing the first patient in the Phase 2 monotherapy dose expansion portion of the ABILITY study is an important milestone that follows encouraging therapeutic activity and tolerability observed during the Phase 1 dose escalation study. Having established the optimal dosing regimen, we look forward to reporting initial results from the monotherapy and combination arms of the Phase 2 dose expansion portion of the study in the first half of 2024. The combination arm of the trial evaluating MDNA11 with pembrolizumab is expected to commence by the end of this year."
In the Phase 1 monotherapy dose escalation portion of the study, which evaluated 20 patients, MDNA11 was well tolerated with promising single-agent activity. As of the data cutoff date of June 20, 2023, responses included one confirmed durable (> one year) partial response in a heavily pretreated patient with metastatic pancreatic cancer who continues on treatment with MDNA11 and six patients with stable disease. Of note, one patient with melanoma experienced prolonged stable disease, which lasted over 1.5 years.
The ABILITY-1 study (NCT05086692) is a global, multi-center, open-label study that assesses the safety, tolerability, pharmacokinetics, pharmacodynamics and anti-tumor activity of MDNA11 as monotherapy or in combination with pembrolizumab (Keytruda®). In the monotherapy dose expansion of the Phase 2 study, up to 40 patients are expected to be enrolled and administered MDNA11 (90µg/kg) intravenously once every two weeks. The expansion cohorts in the monotherapy arm of the study include advanced melanoma, non-melanoma skin cancer or microsatellite instability (MSI)-high or mismatch repair (MMR) deficient cancers.
About MDNA11
MDNA11 is an intravenously administered, long-acting "beta-only" recombinant interleukin-2 (rIL-2) specifically engineered to overcome the shortcomings of rhIL-2 (aldesleukin) by preferentially activating immune effector cells (CD8+ T and NK cells) responsible for killing cancer cells, with minimal or no stimulation of immunosuppressive Tregs. These unique proprietary features of the IL-2 Superkine have been achieved by incorporating seven specific mutations and genetically fusing it to a recombinant human albumin scaffold to improve the pharmacokinetic (PK) profile and pharmacological activity of MDNA11 due to albumin's natural propensity to accumulate in highly vascularized sites and tumor draining lymph nodes. MDNA11 is currently being evaluated in the Phase 1/2 ABILITY-1 study as both a monotherapy and in combination with pembrolizumab (Keytruda®).
