Warsaw, Poland – JJP Biologics, a leading biopharmaceutical company, announced on Thursday that it has received approval from the European Medicines Agency to initiate a phase 1 clinical trial for its innovative anti-CD89 monoclonal antibody, JJP-1212 (EudraCT: 2023-508661-33-00). This approval marks a significant milestone as JJP Biologics becomes the first company to conduct human trials with this novel therapeutic antibody.
JJP-1212, an IgG4-κ anti-CD89 antagonist, is designed to treat autoimmune and fibrotic diseases where IgA autoantibodies play a crucial role in disease pathology, such as linear IgA bullous dermatosis (LABD). Currently, there are no approved treatments for LABD in the European Union.
The phase 1 trial will be conducted in Poland and will involve 48 healthy adult volunteers. The primary objective of the study is to thoroughly evaluate the safety profile of JJP-1212. Participants will receive the antibody through intravenous infusions, administered in both single and multiple ascending dose cohorts.
“This is a historically unprecedented approval of a first-in-human clinical trial for a novel large molecule therapy from Poland,” said Pawal Szczepański, COO and management board member at JJP Biologics. “This landmark approval will strengthen the position of the Polish biotech sector on the global stage, paving the way for many innovative therapies to emerge from this part of Europe, including future developments from JJP Biologics.”
The company stated that the study aims to gather comprehensive safety and tolerability data, along with a full pharmacokinetic-pharmacodynamic (PKPD) analysis. This data will be crucial for optimizing treatment plans in future patient studies. The phase 1 results are expected to support subsequent phase 2 trials across various therapeutic areas and regions, including the United States.
Louis Boon, PhD, CSO and management board member at JJP Biologics, reflected on the journey leading to this approval. “I vividly remember the day Prof. Marjolein van Egmond from VU University Medical Center Amsterdam, and a member of our Scientific Advisory Board, shared insights on the IgA-CD89 axis and its role in autoimmune diseases. This approval is a significant milestone for patients suffering from IgA-mediated autoimmune or fibrotic diseases and validates the preclinical work done on JJP-1212. I am immensely grateful to the JJP Biologics team and the Starak family for their unwavering support.”
JJP Biologics is also exploring the development of companion diagnostics to use serum IgA autoantibodies as biomarkers for personalized treatment with JJP-1212. By binding to CD89, JJP-1212 inhibits IgA binding and subsequent activation of CD89+ immune cells, thereby preventing the release of chemoattractant molecules and other processes that lead to severe inflammation and tissue damage.
“At JJP Biologics, we are committed to advancing science that improves outcomes for patients with rare diseases through innovative treatments,” said Dawid Łyżwa, PhD, head of clinical development at JJP Biologics. “The approved study is designed to quickly build a foundation for further development, offering new treatment options for those living with high-burden autoimmune disorders. The anticipated study results will not only validate the safety of JJP-1212 but also inform its future development scope.”
The commencement of this trial signifies a promising step towards new therapeutic options for autoimmune and fibrotic diseases, with JJP Biologics leading the charge in this innovative field.
