JJP Biologics Announces Positive Decision to Run First-in-Human Clinical Trial of Anti-Inflammatory mAb JJP-1212 (Anti-CD89)

JJP Biologics received a positive finding in the evaluation of a clinical trial application for a Phase I study of a potential first-in-class anti-CD89 antagonist, the monoclonal antibody JJP-1212, for the treatment of various IgA-mediated autoimmune and fibrotic diseases.

WARSAW, Poland, May 29, 2024–(BUSINESS WIRE)–JJP Biologics, a private biopharmaceutical company developing innovative antibody-based therapies, announces a positive decision, issued by the European Medicines Agency, regarding the application for a clinical trial 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.

To date, JJP Biologics is the first Polish company to receive approval to conduct the first human clinical trial with a new therapeutic monoclonal antibody.

The phase I trial will be performed in Poland. The study endpoints are designed for a comprehensive assessment of the safety profile of the treatment. The drug will be administered by intravenous infusion in escalating single and multiple dose cohorts. The population size was determined to be 48 healthy adult volunteers.

Study results will provide data on the safety and tolerability of JJP-1212, as well as comprehensive PK/PD profiles that will then help determine optimal treatment regimens in future studies in patient populations. JJP Biologics intends to use the Phase I results as supporting data for a set of Phase II trials, across a range of therapeutic areas and regions (including the EU and US).

“I remember very well the day when Professor Marjolein van Egmond, from the VU University Medical Center in Amsterdam and member of the scientific advisory board of 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. Although safety data are still needed, this decision constitutes. an important milestone for patients suffering from IgA-mediated autoimmune or fibrotic diseases and validates the preclinical package of JJP-1212 very grateful to the JJP Biologics team for all their efforts and to the Starak family for their trust and support. continued support. – Louis Boon, Ph.D., CSO and board member of JJP Biologics.

According to Paweł Szczepański, COO and board member of JJP Biologics – “This is an unprecedented approval in the history of a first-in-human clinical trial for a new large molecule therapy in Poland. It constitutes a milestone that will further strengthen the position of the Polish biotechnology sector on the global map, paving the way for numerous innovations. upcoming therapies from this part of Europe, including upcoming ones from the JJP Biologics development platform.

“At JJP Biologics, we value science that helps improve outcomes for patients with rare diseases through the delivery of innovative treatments. The recently approved study is ambitiously designed to quickly lay the foundation for further development to offer new treatment options for people living with high-burden autoimmune diseases.” – Dawid Łyżwa, Ph.D., Head of Clinical Development at JJP Biologics.”The expected results of the study will not only validate the safety, but also help decide on the expansion of the development scope of JJP-1212.“

“I am delighted to learn that JJP Biologics is now commencing its clinical program aimed at providing first-in-class treatment for IgA-mediated diseases. I hope that the readings in JJP-1212-01-01 will provide a solid foundation for continued clinical development in various therapeutic areas, well beyond dermatology. » – Professor Christoph Hammers, University Medical Center Regensburg, Germany.

“Because JJP-1212 targets the underlying cause of the disease, if successful, it will provide a valuable treatment option for a range of conditions with significant unmet medical needs and could result in clinical remissions for the multiplicity serious patients. JJP Biologics demonstrates its commitment and dedication to patient safety and well-being.” – Professor Pascal Joly, Rouen University Hospital, France

JJP-1212

JJP-1212 is a first-in-class anti-CD89 IgG4-κ antagonist being developed to treat autoimmune and fibrotic diseases in which IgA autoantibodies are a key component of disease pathophysiology. Alongside linear IgA bullous dermatosis (LABD), JJP-1212 is being developed for a wide range of autoimmune and fibrotic diseases in which IgA is known to have significant pathogenic involvement (e.g., rheumatoid arthritis , axial spondyloarthritis, systemic lupus erythematosus, neutrophilic asthma, chronic disease). obstructive pulmonary disease, idiopathic pulmonary fibrosis, cystic fibrosis, hidradenitis suppurativa, non-alcoholic 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 COMICS

LABD, also known as linear IgA bullous dermatosis or linear IgA disease, is a chronic, debilitating disease that causes skin separation, blistering, and in extreme cases, vision loss. Currently, no drugs 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 organic products

JJP Biologics is a clinical-stage biotechnology company focused on developing therapeutic monoclonal antibodies with companion diagnostics for personalized treatment. JJP Biologics continues 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 anti-CD270 checkpoint inhibitor first class. , for solid tumors. The JJP-1212 project is co-financed from the state budget by the Polish Medical Research Agency (No: 2022/ABM/05/00011).

JJP Biologics is a privately funded biotechnology, partly funded by programs managed by the Polish Medical Research Agency. In 2022, JJP Biologics became the first Polish company whose biological drug candidate (JJP-1212) received orphan drug designation from the European Commission, following the recommendation of the European Medicines Agency.

For more information, visit www.jjpbiologics.com and join the #smartgoose community by following us on LinkedIn. For more information, please contact: Paweł Szczepański, COO, [email protected].

THE REFERENCES

https://www.ncbi.nlm.nih.gov/books/NBK526113/

https://www.ema.europa.eu/en/medicines/human/orphan-designations/eu-3-22-2702

NOTICE OF DISCLOSURE

We undertake no obligation to publicly update any forward-looking statements.

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Contacts

Paweł Szczepański, COO, [email protected]