Medannex’s First-in-class Therapy receives EMA Orphan Designation for Pancreatic Cancer
Medannex’s First-in-class Therapy receives EMA Orphan Designation for Pancreatic Cancer
Medannex Ltd (Edinburgh) announced today that MDX-124, a monoclonal antibody against annexin-A1, has received Orphan Medicinal Product positive opinion from the European Medicines Agency (EMA) for the treatment of pancreatic cancer.
This acknowledges the unmet medical need in this area, and the significant potential of MDX-124 to improve treatment options for pancreatic cancer. The EMA’s decision was driven by compelling non-clinical data showing inhibition of tumour growth and improved survival, as well as powerful synergy between MDX-124 and current standard of care treatments.
Pancreatic cancer is a chronically debilitating and life-threatening condition associated with markedly reduced life expectancy.
The designation provides Medannex with special incentives in the EU, including regulatory fee reductions and 10 years of marketing exclusivity once MDX-124 gains approval.
Medannex CEO Ian Abercrombie said: ‘We’re delighted to receive this positive opinion from the EMA, a further endorsement of the potential of MDX-124 as a powerful new oncology therapy. This brings us another step closer to our goal of providing new treatment options for people living with cancer.’
The Orphan Medicinal Product designation has been subsequently granted by the European Commission and can be viewed in the EU Orphan Register here:
https://ec.europa.eu/health/documents/community-register/html/o2752.htm
About Medannex Ltd: Medannex is a clinical-stage Scottish biopharmaceutical company headquartered in Edinburgh. The company is developing novel treatments for various cancers, autoimmune diseases and other conditions: https://medannex.org
About MDX-124: MDX-124 is a humanised monoclonal antibody, and the first agent to specifically target and inhibit annexin-A1, a protein known to play a key role in the development of cancers, autoimmune diseases and other conditions. Medannex will generate initial clinical data in 2023 from a first in human study evaluating MDX-124 in patients with locally advanced, unresectable or metastatic solid malignancies.
Medannex Ltd enquiries – email jamesingham@medannex.org