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DRUG:

MDNA11

i
Other names: MDNA11
Associations
Trials
Company:
Medicenna
Drug class:
IL-2 stimulant, CD122 agonist
Related drugs:
Associations
Trials
9ms
ABILITY: A Beta-only IL-2 ImmunoTherapY Study (clinicaltrials.gov)
P1/2, N=115, Recruiting, Medicenna Therapeutics, Inc. | Trial primary completion date: Sep 2024 --> Jun 2026
Trial primary completion date • Combination therapy • Checkpoint inhibition • Metastases
|
Keytruda (pembrolizumab) • MDNA11
over1year
ABILITY: A Beta-only IL-2 ImmunoTherapY Study (clinicaltrials.gov)
P1/2, N=115, Recruiting, Medicenna Therapeutics, Inc. | Trial completion date: Dec 2024 --> Dec 2026
Trial completion date • Combination therapy • Checkpoint inhibition • Metastases
|
Keytruda (pembrolizumab) • MDNA11
2years
Pharmacokinetic and Pharmacodynamic Profile of a First-in-Human Study with MDNA11, an Engineered Long-Acting Beta-only IL-2 Agonist (SITC 2022)
Conclusions Cumulative PD readouts to date are consistent with the anticipated pharmacological effect of MDNA11 demonstrating dose dependent activation of various biomarkers on effector cells without concomitant stimulation of immune suppression. Updated PK, PD and ADA data will be presented as dose escalation continues.
P1 data • PK/PD data • IO biomarker
|
CD8 (cluster of differentiation 8) • IL2RA (Interleukin 2 receptor, alpha) • IL2 (Interleukin 2) • FCGR2A (Fc fragment of IgG receptor IIa) • FCGR2B (Fc Fragment Of IgG Receptor IIb)
|
CD8 expression
|
MDNA11
2years
Interim single-agent safety and anti-tumor activity from dose escalation phase of ABILITY study on MDNA11, a long-acting beta-only IL-2 agonist. (SITC 2022)
Conclusions MDNA11 is well tolerated with no DLTs up to target dose of 60 mg/kg (DL4) and enrolment for 90 mg/kg (DL5) has initiated. There is dose-dependent increase in plasma exposure and evidence of single-agent anti-tumor activity in 4 of 10 (SD) patients.
Clinical
|
CD8 (cluster of differentiation 8) • IL2RA (Interleukin 2 receptor, alpha) • IL2 (Interleukin 2)
|
MDNA11
over2years
Fine-tuned long-acting interleukin-2 superkine potentiates durable immune responses in mice and non-human primate. (PubMed, J Immunother Cancer)
Recombinant human interleukin-2 (rhIL-2, aldesleukin) is Food and Drug Administration approved for the treatment of metastatic melanoma and renal cell carcinoma and has achieved durable response in a subset of patients. In a NHP model, MDNA11 was well tolerated while triggering durable and potent immune responses including expansion of lymphocytes without significant effect on Tregs and eosinophils, the latter been linked to an increased risk of vascular leak syndrome. MDNA11 is a next generation long-acting IL-2 immunotherapeutic with a highly favorable pharmacodynamic profile that translates to a strong therapeutic efficacy in preclinical tumor models and a strong and durable immune response in NHP.
Preclinical • Journal
|
CD8 (cluster of differentiation 8) • IL2 (Interleukin 2)
|
Proleukin (aldesleukin) • MDNA11
over4years
[VIRTUAL] In vitro and in vivo characterization of MDNA11: A long-acting “beta-only” IL-2 superkine in syngeneic mice tumor models and nonhuman primates. (ASCO 2020)
Background: Use of IL-2 (Proleukin) remains limited due to its short half-life, toxicity, and its ability to preferentially activate Tregs resulting in unwanted immune suppression. The long-acting MDNA11 Superkine has superior potency over IL-2 at activating naïve CD8 T-cells and NK cells, while exhibiting diminished Treg activation. This molecule potently inhibited tumor growth and induced durable regression and long-term memory response. Studies in NHP showed prolonged proliferation of immune effector cells lasting almost two weeks post-MDNA11 administration.
Preclinical • IO biomarker
|
CD8 (cluster of differentiation 8) • IL2RA (Interleukin 2 receptor, alpha) • IL2 (Interleukin 2)
|
Proleukin (aldesleukin) • MDNA11