JJP Biologics to Launch First Human Trial of Anti-Inflammatory mAb JJP-1212

JJP Biologics, a private biopharmaceutical company based in Warsaw, Poland, has received a positive assessment from the European Medicines Agency (EMA) for its Clinical Trial Application (CTA) to initiate a Phase I trial of JJP-1212, an innovative anti-CD89 monoclonal antibody. This novel drug is intended to treat various IgA-mediated autoimmune and fibrotic diseases. This landmark achievement makes JJP Biologics the first company from Poland to obtain approval for a First-in-Human clinical trial with a novel therapeutic monoclonal antibody.

The Phase I trial will be conducted in Poland and will involve 48 healthy adult volunteers. The primary goal is to comprehensively evaluate the safety profile of JJP-1212. The drug will be administered through intravenous infusion in both single and multiple ascending dose cohorts. The study's endpoints are designed to provide crucial data on the safety and tolerability of JJP-1212, along with complete pharmacokinetic (PK) and pharmacodynamic (PD) profiles. These data will be instrumental in determining the optimal treatment regimens for future studies involving patient populations.

JJP Biologics plans to use the findings from this Phase I trial to support a series of Phase II trials in various therapeutic areas across regions including the EU and the US. The company’s Chief Scientific Officer, Louis Boon, Ph.D., highlighted the importance of this milestone, emphasizing the potential of JJP-1212 to treat patients suffering from IgA-mediated autoimmune or fibrotic diseases. He expressed gratitude towards the JJP Biologics team and the Starak family for their unwavering support.

Paweł Szczepański, COO at JJP Biologics, described the approval as historically unprecedented for Poland's biotech sector. He believes this achievement will strengthen Poland's position on the global biotech landscape and pave the way for more innovative therapies from the region. Dawid Łyżwa, Ph.D., Head of Clinical Development at JJP Biologics, indicated that the study is ambitiously designed to build a foundation for developing new treatment options for those living with high-burden autoimmune disorders.

Several experts, including Prof. Christoph Hammers from the University Medical Center Regensburg, Germany, and Prof. Pascal Joly from Rouen University Hospital, France, expressed optimism about the potential of JJP-1212. They believe that the drug could serve as a valuable treatment option for conditions with high unmet medical needs, driving clinical remissions for many severe patients.

JJP-1212 is a first-in-class IgG4-κ anti-CD89 antagonist aimed at treating autoimmune and fibrotic diseases where IgA autoantibodies play a significant role. The drug is being developed for a range of conditions, including rheumatoid arthritis, systemic lupus erythematosus, idiopathic pulmonary fibrosis, and IgA nephropathy, among others. JJP Biologics is also exploring the development of companion diagnostics using serum IgA autoantibodies as biomarkers for personalized treatment with JJP-1212.

One specific disease target for JJP-1212 is Linear IgA Bullous Dermatosis (LABD), a chronic condition that causes skin blistering and can lead to significant complications like vision loss. Currently, no approved treatments for LABD exist in the European Union, making the development of JJP-1212 particularly significant.

JJP Biologics is a clinical-stage biotechnology company focused on developing therapeutic monoclonal antibodies and companion diagnostics for personalized treatment. The company's pipeline includes JJP-1212 for autoimmune and fibrotic diseases and JJP-1008, an anti-CD270 checkpoint inhibitor for solid tumors. The JJP-1212 Project is co-financed by the Polish Medical Research Agency. In 2022, JJP-1212 received Orphan Drug Designation from the European Commission, further validating its potential impact.

This approval and subsequent trial mark a significant milestone for JJP Biologics and the Polish biotech sector, offering hope for new treatments for autoimmune and fibrotic diseases.