Pharma Focus Asia

Medicenna Therapeutics Administers Initial Dose in Phase 2 Monotherapy Dose Expansion Component of ABILITY Study for Assessment of MDNA11 in Specific Solid Tumor Varieties

Thursday, October 26, 2023

Medicenna Therapeutics Corp. has made an important announcement regarding its clinical-stage immunotherapy program. The company has initiated the dosing of the first patient in the Phase 2 monotherapy dose expansion segment of the Phase 1/2 ABILITY study, which is focused on evaluating MDNA11, a unique long-acting interleukin-2 (IL-2) super-agonist that exclusively targets beta receptors.

Medicenna, expressed his enthusiasm for this milestone, emphasizing the potential of MDNA11 as a leading next-generation IL-2 super-agonist for the treatment of advanced solid tumors. This development comes after positive results from the Phase 1 dose escalation study, where MDNA11 demonstrated promising therapeutic effects and good tolerability.

During the Phase 1 monotherapy dose escalation phase, involving 20 patients, MDNA11 exhibited favorable tolerability and noteworthy single-agent activity. As of the data cutoff date in June 2023, the results included a durable partial response lasting over a year in a patient with metastatic pancreatic cancer, as well as stable disease in six other patients. Notably, one patient with melanoma experienced prolonged stable disease lasting more than 1.5 years.

The ABILITY-1 study (NCT05086692) is a global, open-label study taking place at multiple centers to evaluate MDNA11's safety, tolerability, pharmacokinetics, pharmacodynamics, and its effectiveness against tumors, either as a standalone treatment or in combination with pembrolizumab (Keytruda®).

In the monotherapy dose expansion segment of the Phase 2 study, up to 40 patients will receive MDNA11 intravenously every two weeks at a dose of 90μg/kg. This expansion will include patients with advanced melanoma, non-melanoma skin cancer, and those with microsatellite instability-high or mismatch repair-deficient cancers.

MDNA11 is a unique, long-lasting "beta-only" recombinant interleukin-2 (rIL-2) that has been specifically engineered to enhance the activation of immune effector cells (CD8+ T and NK cells) responsible for eliminating cancer cells, while minimizing stimulation of immunosuppressive Tregs. This has been achieved through seven specific mutations and genetic fusion with recombinant human albumin to improve its pharmacokinetic profile and pharmacological activity. MDNA11 is currently under evaluation in the Phase 1/2 ABILITY-1 study, both as a monotherapy and in combination with pembrolizumab (Keytruda®).




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