Thursday, May 30, 2024
JJP Biologics, a privately held biopharmaceutical company developing innovative antibody-based therapies, announced the European Medicines Agency (EMA) has approved the Phase I Clinical Trial Application (EudraCT: 2023-508661-33-00) for JJP-1212, the first anti-CD89 antagonist, a first-in-class candidate, in a clinical trial in healthy subjects.
JJP Biologics is the first Polish company to conduct human clinical trials and obtain approval for a groundbreaking monoclonal antibody.
The Phase I clinical trial will be conducted in Poland and aims to comprehensively evaluate the safety profile of the treatment. The drug will be administered to subjects via intravenous administration in two ways: a single ascending dose and multiple ascending doses. The sample size will be 48 healthy adult volunteers.
The study will collect data on the safety, tolerability and complete PK/PD profile of the agent, JJP-1212. This data will be used to determine optimal treatment in future studies of patient populations. JJP Biologics intends to use the results of the Phase I clinical trial to support a series of Phase II clinical trials in various therapeutic areas and regions, including the EU and the US.
"I still vividly remember my conversation with Professor Mayoleen van Egmont, member of JJP Biologics' Scientific Advisory Board and from the VU University Medical Center Amsterdam, who spoke to us about the fascinating biology of the IgA-CD89 axis and its pathological consequences in autoimmune diseases. Measuring the levels of IgA autoantibodies in addition to IgG and IgM levels allows for a more detailed stratification of patients. Although safety data is still required, this decision marks an important milestone for patients with IgA-mediated autoimmune diseases and fibrosis and confirms the efficacy of the preclinical package of JJP-1212. We sincerely thank the entire JJP Biologics team for their dedicated efforts and the Starak Family Foundation for their continued trust and support," said Louis Born, CSO and Member of the Board of Directors of JJP Biologics.
"The first large-scale human clinical trial with a molecular therapy from Poland has been approved. This is a historic achievement, which will pave the way for many more innovative treatments to come from Europe, and especially from the region, further strengthening the global position of Poland's biotech sector, including future innovative therapeutics coming from our development platform," said Paweł Szczepański, COO and Member of the Board of Directors of JJP Biologics.
" JJP Biologics' mission is to contribute to scientific advances through the provision of innovative therapies that improve outcomes for patients with rare diseases. The approved study is ambitious and designed to rapidly pave the way for the development of new therapeutic options to provide patients with serious autoimmune diseases. The results of this study will not only confirm the safety of JJP 1212, but also inform decisions on expanding its development scope," said Dawid Łyżwa, Head of Clinical Development at the company .
" We are very pleased that JJP Biologics has initiated a clinical program aimed at developing a groundbreaking therapeutic agent for IgA-mediated diseases. We hope that the results of the JJP-1212-01-01 study will provide a strong basis for further clinical development not only in dermatology but also in various therapeutic areas," said Professor Christoph Hammer, Medical Center Regensburg, Germany.
" Because JJP-1212 acts directly on the root cause of the disease, if successful, it could be a breakthrough treatment for many patients who are difficult to cure with conventional treatments. It also has the potential to promote clinical remission in severe patients, making it an effective treatment for diseases with high medical need. JJP Biologics has clearly demonstrated its commitment and dedication to patient safety and health ," said Professor Pascal Joly, University Hospital of Rouen, France.
JJP-1212
JJP-1212 is a first-in-class IgG4-κ anti-CD89 antagonist being developed for the treatment of autoimmune diseases and fibrotic diseases, where IgA autoantibodies play a key role in the pathophysiology. In addition to linear IgA bullous dermatosis (LABD), JJP-1212 is being developed for the treatment of autoimmune diseases and fibrotic diseases where IgA has been implicated as an important pathogenic factor. Examples of target diseases include rheumatoid arthritis, axial spondyloarthritis, systemic lupus erythematosus, neutrophilic asthma, chronic obstructive pulmonary disease, idiopathic pulmonary fibrosis, cystic fibrosis, hidradenitis suppurativa, nonalcoholic steatohepatitis, IgA nephropathy, and IgA vasculitis. JJP Biologics is exploring the development of companion diagnostics for various indications using serum IgA autoantibodies as a biomarker for personalized therapy with JJP-1212.
L.A.B.D.
Linear IgA herpetic dermatosis (LABD) is a debilitating chronic disease that causes skin separation, blistering, and in severe cases, vision loss. Currently, there are no medicines approved for the treatment of LABD in the European Union. The estimated incidence of LABD is 0.2-2.3 cases per million people per year.
JJP Biologics
JJP Biologics is a clinical-stage biotechnology company focused on the development of therapeutic monoclonal antibodies combined with companion diagnostics to provide personalized treatments for patients. The company is developing its own product candidates as well as collaboration projects with scientific partners. The company is also developing programs targeting common immune pathways for the treatment of autoimmune diseases and cancer. The pipeline includes 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 the treatment of solid tumors. The JJP-1212 project is co-funded by the state budget of the Polish Agency for Medical Research (No: 2022/ABM/05/00011).
JJP Biologics is a private biotechnology company funded by a program run by the Polish Institute for Medical Research. In 2022, the company became the first Polish company developing a medicine that received orphan drug designation from the European Commission, following the recommendation of the European Medicines Agency.
For more information, please visit www.jjpbiologics.com . You can also follow us on LinkedIn and join the #smartgoose community. For further information, please contact Paweł Szczepański, COO, at [email protected] .
References
https://www.ncbi.nlm.nih.gov/books/NBK526113/
https://www.ema.europa.eu/en/medicines/human/orphan-designations/eu-3-22-2702
Disclosure Notice
The Company undertakes no obligation to publicly update any forward-looking statements.
The official version of this press release is the original language version. The translated language versions are provided for the convenience of readers and have no legal effect. When using the translated language version as a reference, please refer to the original language version, which is the only version that has legal effect.
Contact
Paweł Szczepański, COO, [email protected]
Source: businesswire.com
