Phase 1 Trial Approved for Anti-Inflammatory mAb JJP-1212

The biopharmaceutical company JJP Biologics announced Thursday that it will begin a phase 1 clinical study with its potential first-in-class anti-CD89 antagonist, JJP-1212 (EudraCT: 2023-508661-33-00). The positive decision, issued by the European Medicines Agency, makes JJP Biologics the first company to receive approval to perform human clinical trials with a novel therapeutic monoclonal antibody.

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JJP-1212 is a IgG4-κ anti-CD89 antagonist that is being developed to treat autoimmune and fibrotic disease in with IgA autoantibodies are a key element of the disease pathophysiology, including linear IgA bullous dermatosis (LABD). Currently, no medicinal products are approved for the treatment of LABD in the European Union.

The company said the phase 1 trial will take place in Poland and it hopes to include 48 healthy adult volunteers. The study aims to gain knowledge to complete a comprehensive evaluation of the treatment’s safety profile. JJP-1212 will be given to patients through an intravenous infusion 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,” Pawal Szczepański, COO and management board member at JJP Biologics, said in the press release. “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.”

JJP Biologics wrote the goal of the study is to provide insight on the safety and tolerability of JJP-1212, and full pharmacokinetic-pharmacodynamic (PKPD) analysis that will allow researchers to determine the optimal treatment plan in future studies with patient populations. The company said in the press release that it intends on using phase 1 results as supporting data for a set of phase 2 trials, in a range of therapeutic areas and regions, including 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,” said Louis Boon, PhD, CSO and management board member at JJP Biologics, in the press release. “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.”

JJP Biologics wrote that it is exploring the development of companion diagnostics in various indications using serum IgA autoantibodies as biomarkers for personalized treatment with JJP-1212. After binding to CD89, the company said JJP-1212 inhibits binding of IgA and subsequent activation of the CD89+ immune cell, therefore blocking the release of chemoattractant molecules, epitope spreading, and other functions that lead to severe inflammation and tissue damage.

“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, PhD, head of clinical development at JJP Biologics, said in the press release. “Expected study results will not only validate the safety but also contribute to deciding on extension of JJP‑1212’s development scope.”

Reference

JJP Biologics announces positive decision to execute a first-in-human clinical trial of anti-inflammatory mAb JJP-1212 (anti-CD89). News Release. Business Wire. May 29, 2024. Accessed May 29, 2024. https://www.businesswire.com/news/home/20240528430176/en/JJP-Biologics-Announces-Positive-Decision-to-Execute-a-First-in-Human-Clinical-Trial-of-Anti-Inflammatory-mAb-JJP-1212-anti-CD89