Clinical Trials
Medicenna is dedicated to developing innovative immunotherapies for patients with advanced cancers. Our goal is to enhance the immune system's ability to fight disease, providing new hope for patients and their families.
Phase 1/2 study of MDNA11 as a novel treatment for solid tumors
ABILITY-1 Study
This study is in collaboration with Merck Sharp & Dohme LLC, a subsidiary of Merck & Co., Inc., Rahway, NJ, USA.
Phase 1b study of MDNA11 as a neoadjuvant immunotherapy in earlier stage melanoma
NEO-CYT Study
This randomized, investigator-initiated study is in collaboration with Fondazione Melanoma Onlus at the National Cancer Institute 'G. Pascale Foundation'. Fondazione Melanoma Onlus is the study sponsor.
What is MDNA11?
MDNA11 is an optimized version of interleukin 2 (IL-2, also known by the trade name Proleukin®). The goal of IL-2 therapies is to stimulate the patient's immune system to activate cancer-killing immune cells despite the presence of the cancer-protecting cells used by the cancer to defend itself.
Proleukin was approved by the FDA for treating cancer, and has been found to achieve long-term cures for some patients. However, Proleukin has a major drawback: it needs to be given at high doses multiple times a day over several days. This type of treatment can result in severe side effects, often requiring admission to an intensive care unit.
Medicenna designed MDNA11 to be a much safer and more effective treatment by activating the cancer-killing immune cells of the immune system without the toxicity of Proleukin. In addition, MDNA11 has been modified to have a longer-lasting effect, therefore, only needing to be given once every two weeks, instead of every 8 hours with Proleukin.
Medicenna has a proven track record of taking such drugs into clinic trials for the benefit of patients. To date, data from the ABILITY-1 study show that side effects are markedly reduced and immune cells are robustly activated for up to 2 weeks after a single dose of MDNA11.
ABILITY-1 Study Details
The ABILITY-1 study is open to patients who are 18 years of age or older, have metastatic or advanced solid cancer, and have been assessed by a clinical team to be eligible for the study.
During the study, patients will receive MDNA11 and undergo regular assessments, including blood collection and imaging, to monitor their response to treatment. The study is currently ongoing in the United States, Canada, Australia, Ireland, Portugal, and Spain.
In clinical collaboration with Merck (known as MSD outside of the United States and Canada)
ABILITY-1 Trial Sites
- •Boca Raton Regional Hospital, Boca Raton, Florida
- •Emory - Winship Cancer Institute, Atlanta, Georgia
- •Providence Saint John's Health Center, Santa Monica, California
- •Sharp Memorial Hospital, San Diego, California
- •Karmanos Cancer Institute, Detroit, Michigan
- •Gallipoli Medical Research Foundation, Greenslopes, Queensland
- •University Of The Sunshine Coast, Buderim, Queensland
- •Scientia Clinical Research, Randwick, New South Wales
- •Macquarie University, Sydney, New South Wales
- •Princess Margaret Cancer Center, Toronto, Ontario
- •Mater Misericordiae University Hospital, Dublin, Ireland
- •START Lisbon - Centro De Ensaios Clinicos, ULS Sta Maria, Lisbon
- •Instituto Portugues De Oncologia Do Porto, Porto
- •Institut Catala D'Oncologia (ICO)-Badalona, Badalona
- •START Barcelona / HM Nou Delfos, Barcelona
- •Hospital Universitario Ramon Y Cajal, Madrid
- •START Madrid / Hospital Universitario Fundacion Jimenez Diaz, Madrid
- •Hospital Universitario HM Sanchinarro, Madrid, Spain
NEO-CYT Study Details
Immunotherapy administered prior to surgery has emerged as a clinical and commercial frontier in melanoma and several other solid tumors. Pathologic response endpoints both predict long-term survival outcomes and may provide an efficient regulatory and go-forward signal for immunotherapies.
NEO-CYT is designed to produce early, actionable neoadjuvant data to support the clinical potential of MDNA11 in melanoma and its ability to enhance efficacy of the standard-of-care in this treatment setting.
In collaboration with Fondazione Melanoma Onlus
NEO-CYT Trial Sites
EAP Statement
Medicenna's investigational therapy is not available on an Expanded Access Program (EAP) or Right-to-try basis for patients not qualifying for the ABILITY-1 study. Medicenna will evaluate requests on a case-by-case basis if they decide to consider EAP or Right-to-try use.
Clinical Trial Questions
Clinical Study Participants or other interested individuals with questions about clinical studies conducted by Medicenna or its collaborators, or with related concerns, should not contact Medicenna directly but should instead consult their treating physician or healthcare provider.