JJP Biologics announces a positive recommendation from the Phase I Dose Escalation Committee to move to second cohort in the ongoing single ascending dose (SAD) part of its Phase I Clinical Trial of JJP-1212 in healthy volunteers, followed by a multiple ascending dose (MAD) part to complete the safety and PK/PD assessment.
August 28, 2024
Warsaw, Poland – JJP Biologics, a clinical-stage innovative biotechnology company, has started Phase I Clinical Trial of a potential first-in-class anti-CD89 antagonist, JJP-1212, monoclonal antibody for the treatment of various IgA-mediated autoimmune and fibrotic diseases. JJP Biologics, after receiving positive decision on the clinical trial in May 2024 (EU CT number: 2023-508661-33-00), started the study that is designed as single center trial carried out in Poland with 48 healthy adult volunteers, divided into 6 dosing cohorts. The study endpoints are designed for a comprehensive evaluation of the treatment’s safety profile. The drug candidate JJP-1212 is administered intravenously in single and multiple ascending dose cohorts.
“Proud, grateful and excited” as mentioned by Louis Boon Ph.D., CSO of JJP Biologics, the 3 words that perfectly describe his state-of-mind. “I perfectly remembered my first conversation with Prof. Marjolein van Egmond, in which she convinced me about CD89 as an interesting target for autoimmune and fibrotic diseases. Now, here we are a few years later and the clinical testing of JJP-1212 has been initiated”.
This shows the commitment in JJP Biologics’ journey to bring new and safe treatment options to patients suffering from pathogenic IgA antibodies.
About JJP-1212
JJP-1212 is a first-in-class IgG4-ę anti-CD89 antagonist that is being developed to treat autoimmune and fibrotic diseases in which IgA autoantibodies are a key element of the disease pathophysiology. Alongside Linear IgA Dermatosis (LAD), JJP-1212 is being developed for a wide range of autoimmune- and fibrotic diseases where IgA is known to have significant pathogenic involvement (e.g. rheumatoid arthritis, axial spondyloarthritis, systemic lupus erythematosus, neutrophilic asthma, chronic obstructive pulmonary disease, idiopathic pulmonary fibrosis, cystic fibrosis, hidradenitis suppurativa, nonalcoholic steatohepatitis, IgA nephropathy, IgA vasculitis). JJP Biologics is exploring the development of companion diagnostics in various indications using serum IgA autoantibodies as biomarkers for personalized treatment with JJP-1212.
The European Medicines Agency (EMA) granted JJP-1212 the orphan designation (EU/3/22/2702) and subsequently the Office for Registration of Medicinal Products in Poland authorized the Phase I Clinical Trial in healthy volunteers. With this JJP-1212 is the first New Biological Entity in the history of the Polish biotechnology sector, completely discovered and developed in Poland.
The JJP-1212 project is co-financed by the state budget by the Polish Medical Research Agency (No: 2022/ABM/05/00011).
JJP BIOLOGICS
JJP Biologics is a privately funded, clinical stage biotechnology company that specializes in the development of therapeutic monoclonal antibodies accompanied by companion diagnostics for personalized treatment. JJP Biologics 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 applications in autoimmune diseases and cancer. JJP Biologics current range of programs includes the most advanced JJP-1212, a potential first-in-class anti-CD89 antagonist for (auto)inflammatory diseases, and JJP-1008, a potential first-in-class CD270 checkpoint inhibitor, for solid tumors.
For further information, please contact: info@jjpbiologics.com
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