Big Molecule Watch
October 26, 2020

EMA Issues Positive Opinion for PBP1510

Last week, the EMA issued a positive opinion for Orphan Drug Designation (“ODD”) to Prestige BioPharma’s PBP1510, a first-in-class anti-PAUF monoclonal antibody.  PAUF is found in a majority of pancreatic cancers and plays an important role in disease progression; PBP1510 received ODD for the treatment of pancreatic cancer, for which there is not yet an approved targeted molecular therapy.  Prestige BioPharma’s CEO, Dr. Lisa Park, remarked “The positive opinion of EMA COMP confirms that PBP1510 has once again successfully established to be a globally innovative first-in-class drug. It is expected that the development of PBP1510 will gain more resilience and will have a positive effect in terms of clinical trial procedures and product approval.”

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