Medicenna Announces New Clinical Data Showing Dose-Dependent Stimulation of Anti-Cancer Immune Cells with MDNA11 in the Phase 1/2 ABILITY Study
-- Levels of Ki67+ expression by CD8+ T cells and NK cells increased by 17-fold and 10-fold, respectively, in the third cohort (30 µg/kg dose) when compared to baseline
-- NK cell / Treg and CD8+T cell / Treg ratios increased by 4.4-fold and 2.6 fold, respectively, at the 30 µg/kg dose, demonstrating superior stimulation of cancer fighting immune cells.
-- Significant dose-dependent increases in CD8+ T (>3-fold) and NK (>6-fold) cells indicates potential for further expansion of anti-tumor immune cells as dose-escalation continues
“We believe that the ABILITY study’s early results are promising, as they indicate MDNA11 is potently and selectively stimulating proliferation of cancer fighting immune cells in a dose-dependent manner,” said Dr.
In the ABILITY study, dose escalation cohorts are evaluating MDNA11 monotherapy administered intravenously once every two weeks to patients with advanced solid tumors. The trial’s first two cohorts (n = 4) evaluated MDNA11 doses ≤ 10 µg/kg (IL-2 content of ≤ 2 µg/kg). The trial’s third cohort (n = 4) utilized a dose of 30 µg/kg (IL-2 content of 6 µg/kg). Key findings from these initial dose escalation cohorts include:
- Levels of Ki67+ expression by CD8+ T and NK cells increased 17-fold and 10-fold over baseline, respectively, following treatment with MDNA11 in the trial’s third dose escalation cohort
- MDNA11 treatment led to the dose-dependent and significant expansion of CD8+ T and NK cells at the 30 µg/kg when compared to MDNA11 doses of ≤ 10 µg/kg. Levels of each cell type increased >3-fold and >6-fold over baseline, respectively, in the trial’s third dose escalation cohort.
- MDNA11 preferentially increased anti-cancer CD8+ T cells over pro-tumor Treg cells, as the mean peak CD8+ T cell / Treg ratio increased by 2.6 fold over baseline in cohort 3.
- MDNA11 preferentially increased anti-cancer NK cells over Treg cells, as the mean peak NK cell / Treg ratio increased 4.4-fold over baseline in the trial’s third dose-escalation cohort.
- MDNA11 continues to exhibit an acceptable safety profile. No dose limiting toxicities have been reported in the ABILITY study to date.
About the Phase 1/2 ABILITY Study
The ABILITY (A Beta-only IL-2 ImmunoTherapY) study is designed to assess the safety, pharmacokinetics, pharmacodynamics, and anti-tumor activity of various doses of intravenously administered MDNA11 in patients with advanced, relapsed, or refractory solid tumors. The trial includes an MDNA11 monotherapy arm, as well as a combination arm designed to evaluate MDNA11 with a checkpoint inhibitor. Approximately 80 patients are expected to be enrolled into the ABILITY Study. Following establishment of the recommended Phase 2 dose (RP2D) and optimal treatment schedule in the study’s dose escalation phase, Medicenna plans to conduct a dose expansion phase that will enroll patients with renal cell carcinoma, melanoma, and other solid tumors in monotherapy and combination settings. For more information, see ClinicalTrials.gov Identifier: NCT05086692.
Medicenna is a clinical stage immunotherapy company focused on the development of novel, highly selective versions of IL-2, IL-4 and IL-13 Superkines and first in class Empowered Superkines. Medicenna's long-acting IL-2 Superkine, MDNA11, is a next-generation IL-2 with superior CD122 (IL-2 receptor beta) binding without CD25 (IL-2 receptor alpha) affinity thereby preferentially stimulating cancer killing effector T cells and NK cells. Medicenna’s early-stage BiSKITs™ program, (Bifunctional SuperKine ImmunoTherapies) is designed to enhance the ability of Superkines to treat immunologically “cold” tumors. Medicenna's IL-4 Empowered Superkine, MDNA55, has been studied in 5 clinical trials including a Phase 2b trial for recurrent GBM, the most common and uniformly fatal form of brain cancer. MDNA55 has obtained Fast-Track and Orphan Drug status from the FDA and FDA/EMA, respectively.
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Source: Medicenna Therapeutics Corp.