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

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Posted on May 29, 2024 • 4 minutes read

JJP Biologics has received a positive outcome on clinical trial application evaluation for a Phase 1 study of a potential first-in-class anti-CD89 monoclonal antibody JJP-1212 for the treatment of multiple IgA-mediated autoimmune and fibrotic diseases.

Warsaw, Poland — JJP Biologics, a privately held biopharmaceutical company developing innovative antibody-based therapies, has announced a positive decision from the European Medicines Agency on a 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.

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

The first phase trial will be carried out in Poland. Study endpoints are designed to comprehensively evaluate the safety profile of treatment. The medication will be given by intravenous infusion in single and multiple ascending dose combinations. The 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 identification of optimal treatment regimens in future studies with patient populations. JJP Biologics intends to use the Phase 1 readouts as supporting data for a range of Phase 2 trials, in a range of therapeutic areas and regions (including the EU and US).

“I vividly remember the day when Professor Marjolein van Egmond, VU University Medical Center Amsterdam and member of the Scientific Advisory Board 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 antibodies Beyond IgG and IgM levels While safety data is still needed, this decision is an important milestone for patients with autoimmune or IgA-mediated fibrotic diseases and validates the preclinical package for JJP-1212 For all their efforts and to the Starak family for their continued trust and support. – Louis Boone, Ph.D., Chief Organization Officer and Member of the Board of Directors at JJP Biologics.

According to Paweł Szczepański, Chief Operating Officer and Member of the Board of Directors at JJP Biologics – “This is a historically unprecedented approval of the first human clinical trial for a new large-molecule therapy from Poland. It constitutes a significant milestone that will further strengthen the position of the Polish biotech sector on the global map, paving the way for many more innovative therapies coming from this part of Europe.” .Including the following elements from the JJP Biologics development platform.”

“At JJP Biologics, we value science that helps improve outcomes for rare disease patients by delivering innovative treatments. The recently approved study is ambitiously designed to build a rapid foundation for further development to offer new treatment options for those with high-burden autoimmune disorders.” – David Lesois, Ph.D., Head of Clinical Development at JJP Biologics.”The expected study results will not only validate the safety, but will also contribute to a decision on expanding the development of JJP-1212.“

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“I am pleased to hear that JJP Biologics has now begun its clinical program that strives to provide a first-in-class treatment for IgA-mediated diseases. I hope that the readout of JJP-1212-01-01 will provide a solid foundation for further clinical development in various therapeutic areas, beyond dermatology. – Professor Christoph Hammers, University Medical Center Regensburg, Germany.

“Because JJP-1212 targets the underlying cause of the disease – if successful, it will be a valuable treatment option for a range of conditions with high unmet medical need and may lead to clinical remission for a large number of severely ill patients. JJP Biologics demonstrates commitment and dedication to the safety and well-being of patients.– Professor Pascal Joly, Rouen University Hospital, France

JJB-1212

JJP-1212 is a first-in-class anti-CD89 IgG4-κ antibody being developed for the treatment of autoimmune and fibrotic diseases in which IgA antibodies are a key component of the disease pathophysiology. Besides 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 a significant pathogenic effect (eg, rheumatoid arthritis, axial spondyloarthritis, systemic lupus erythematosus, neutrophilic asthma, Chronic 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 antibodies as biomarkers for personalized therapy with JJP-1212.

LABD

LABD, also known as linear IgA bullous skin disease or linear IgA disease, is a chronic and debilitating disease that results in skin detachment, blistering, and, in extreme cases, vision loss. Currently, no medicinal products are approved for the treatment of LABD in the European Union. The incidence of LABD ranges from 0.2 to 2.3 cases per 1,000,000 people per year.

JGB Biologics

JJP Biologics is a clinical-stage biotechnology company specializing in the development of therapeutic monoclonal antibodies with companion diagnostics for personalized therapy. JJP Biologics seeks to develop its product candidates as well as projects undertaken in collaboration 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 for the treatment of autoimmune and fibrotic diseases, and JJP-1008, a potential first-in-class anti-CD270 checkpoint inhibitor 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).

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JJP Biologics is a privately funded biotechnology company, partly funded by programs administered 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, on the recommendation of the European Medicines Agency.

For more information visit www.jjpbiologics.com And join the #smartgoose community by following us LinkedIn. For more information, please contact: Paweł Szczepański, Operations Manager, info@jjpbiologics.com.

References

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

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

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