APB-A2

JJP Biologics has received a positive conclusion on the Clinical Trial Application assessment for a Phase I Study of a potential first-in-class anti-CD89 antagonist, JJP-1212 monoclonal antibody for the treatment of various IgA-mediated autoimmune- and fibrotic diseases. WARSAW, Poland--(BUSINESS WIRE)-- JJP Biologics, a private biopharmaceutical company developing innovative antibody-based therapies, announces a positive decision, issued by the European Medicines Agency, on the Clinical Trial Application to conduct a phase I clinical study in healthy participants (EudraCT: 2023-508661-33-00) with their potential first-in-class anti-CD89 antagonist, JJP-1212. Up to date, JJP Biologics is the first Polish company to receive approval to perform the First-in-Human clinical trial with a novel therapeutic monoclonal antibody. The Phase I trial will be executed in Poland. The study endpoints are designed for a comprehensive evaluation of the treatment's safety profile. The drug will be administered via intravenous infusion in single and multiple ascending dose cohorts. Population size was determined as 48 healthy adult volunteers. The study results will provide data on the safety and tolerability of JJP-1212, and full PK/PD profiles that subsequently enable the determination of optimal treatment regimens in future studies with patient populations. JJP Biologics intends to use Phase I read-outs as supporting data for a set of Phase II trials, in a range of therapeutic areas, and regions (including EU and the US). “I clearly remember the day when, Prof. Marjolein van Egmond, VU University Medical Center Amsterdam and Scientific Advisory Board member at JJP Biologics, told me about the exciting biology of the IgA-CD89 axis and its pathological consequences in autoimmunity. Stratification of patients can easily be achieved by measuring IgA autoantibodies beyond IgG and IgM levels. While safety data are still needed, this decision is an important milestone for patients suffering from IgA-mediated autoimmune or fibrotic diseases and validates the preclinical package of JJP-1212. I am very grateful towards the JJP Biologics team for all their efforts and the Starak family for their continued trust and support.” - Louis Boon, Ph.D., CSO and Management Board Member at JJP Biologics. According to Paweł Szczepański, COO and Management Board Member at JJP Biologics - “This is a historically unprecedented approval of a first-in-human clinical trial for a novel large molecule therapy from Poland. It forms a landmark that will further strengthen the position of the Polish biotech sector on the global map blazing the trail for many innovative therapies to come from this part of Europe. Including the next ones from the development platform of JJP Biologics.” “At JJP Biologics, we value science that helps to improve outcomes for rare-disease patients via delivery of innovative treatments. The recently approved study is ambitiously designed to swiftly build a foundation for further development to offer new treatment options for those living with high-burden autoimmune disorders.” – Dawid Łyżwa, Ph.D., Head of Clinical Development at JJP Biologics. “Expected study results will not only validate the safety but also contribute to deciding on extension of JJP‑1212’s development scope.” “I am delighted to hear that JJP Biologics is now starting its clinical program striving for delivery of a first-in-class treatment for IgA-mediated disease. I hope that JJP-1212-01-01 read-outs will deliver a strong foundation for further clinical development in various therapeutic areas, well beyond dermatology.” – Prof. Christoph Hammers, University Medical Center Regensburg, Germany. “As JJP-1212 targets the underlying cause of the disease – in case of success, it will be a valuable treatment option for a set of conditions with high unmet medical needs and may drive the clinical remissions for the multiplicity of severe patients. JJP Biologics demonstrates the commitment and devotion to the safety and wellbeing of patients.” – Prof. Pascal Joly, Rouen University Hospital, France JJP-1212 JJP-1212 is a first-in-class IgG4-κ 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 Bullous Dermatosis (LABD), 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. LABD LABD, also known as Linear IgA Bullous Dermatosis or linear IgA disease, is a chronic, debilitating disease that leads to skin separation, blistering, and in extreme cases, vision loss. Currently, no medicinal products are approved for the treatment of LABD in the European Union. The estimated incidence of LABD ranges from 0.2 to 2.3 cases per 1,000,000 people per year. JJP Biologics JJP Biologics is a 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 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’ pipeline includes the most advanced JJP-1212, a potential first-in-class anti-CD89 antagonist for the treatment of autoimmune- and fibrotic diseases, and JJP-1008, a potential first-in-class anti-CD270 checkpoint inhibitor, for solid tumors. JJP-1212 Project is co-financed by the state budget by the Polish Medical Research Agency (No: 2022/ABM/05/00011). JJP Biologics is a privately funded biotech, partially financed from programs run by the Polish Medical Research Agency. In 2022, JJP Biologics became the first Polish company whose biological drug candidate (JJP-1212) received an Orphan Drug Designation from the European Commission, following the recommendation of the European Medicines Agency. For more information visit and join the #smartgoose community by following us on LinkedIn. For further information, please contact: Paweł Szczepański, COO, info@jjpbiologics.com. REFERENCES DISCLOSURE NOTICE We do not undertake any obligation to publicly update any forward-looking statements. View source version on businesswire.com: Contacts Paweł Szczepański, COO, info@jjpbiologics.com Source: JJP Biologics View this news release online at: