JJP Biologics announces successful manufacturing of first clinical GMP drug substance and drug product batch for intravenous administration of JJP-1212 (a potential first-in-class CD89 antagonist)

The successful manufacturing of intravenous JJP-1212 drug product ensures sufficient supply for initiation of JJP Biologics’s first-ever Phase I clinical trial in healthy subjects

June 15, 2023

WARSAW, Poland – JJP Biologics, a private company that specializes in the development of proprietary biologic agents for personalized medicine approaches, has announced successful manufacturing of their first clinical GMP drug substance (DS) and drug product (DP) for intravenous administration of JJP-1212, their potential first-in-class CD89 antagonist. With the successful manufacturing of the first ever clinical GMP batch of DS and DP for JJP-1212, JJP Biologics secures sufficient supply for their plans to go into healthy subjects in their first ever Phase I clinical trial, and when successful, subsequent Phase II in the rare autoimmune blistering disease linear IgA bullous dermatosis (LABD) and an exploratory Phase IIa in autoimmunity.
JJP-1212 is a first-in-class IgG4-κ CD89 antagonist that is being developed to treat autoimmune and inflammatory diseases where IgA antibodies are a key part of the disease mechanism. Previously, JJP-1212 has been designated as Orphan Medicinal Product by the European Commission for the treatment of LABD. Alongside LABD, JJP-1212 is being developed for a wide range of autoimmune and inflammatory diseases where IgA is known to have significant pathogenic involvement (e.g. rheumatoid arthritis, systemic lupus erythematosus, chronic obstructive pulmonary disease, idiopathic pulmonary fibrosis, cystic fibrosis, hidradenitis suppurativa, dermatitis herpetiformis, IgA nephropathy, IgA vasculitis). JJP Biologics is exploring development of companion diagnostics in various indication using serum IgA autoantibodies as biomarker for a personalized treatment with JJP-1212.
JJP Biologics sp. z o.o. is a pre-clinical-stage biotechnology company that specializes in the development of therapeutic monoclonal antibodies accompanied by companion diagnostics for personalized treatment. JJP Biologics is a privately funded biotech which pursues the development of its own product candidates as well as projects executed in cooperation with scientific partners. The company’s programs target general immune pathways that have application in autoimmune diseases and cancer. JJP Biologics currently has a range of programs including the most advanced JJP-1212 program for autoimmunity and an JJP-1008 program for immune-oncology. For more information visit www.jjpbiologics.com and join the #smartgoose community by following us on LinkedIn
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