JJP-BIOLOGICS
29.5.2024 08:56:34 CEST | Business Wire | Press release
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 www.jjpbiologics.com and join the #smartgoose community by following us on LinkedIn. For further information, please contact: Paweł Szczepański, COO, 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
DISCLOSURE NOTICE
We do not undertake any obligation to publicly update any forward-looking statements.
To view this piece of content from cts.businesswire.com, please give your consent at the top of this page.
View source version on businesswire.com: https://www.businesswire.com/news/home/20240528430176/en/
About Business Wire
Subscribe to releases from Business Wire
Subscribe to all the latest releases from Business Wire by registering your e-mail address below. You can unsubscribe at any time.
Latest releases from Business Wire
Pacífico Mexinol Celebrates the Symbolic Groundbreaking in Topolobampo, Positioning Mexico in the New Low-Carbon Chemical Industry24.4.2026 02:29:00 CEST | Press release
The initiative brings together governments, diplomats, and global investors around a Net Zero industrial model. The project establishes Topolobampo, Sinaloa as a key hub for industrial development in North America. The Pacifico Mexinol project (“Mexinol”) celebrated the beginning of its pre-construction phase by symbolically laying a first stone, marking the start of one of the most significant global industrial investments in blue and ultra-low carbon methanol. The event brought together diplomats, authorities, and national and international business leaders, reflecting the project’s strategic importance for Mexico and its integration into the emerging low-carbon economy. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260423775301/en/ Adolfo Murietta, Project Shareholder; Rommel Gallo, CEO Transition Industries; Ron Johnson, United States Ambassador to Mexico; Drew Hoster, Counsel General of the United States in Hermosillo,
The New World ID: Proof of Human for the AI Era Scales Across the Digital Platforms People and Businesses Use Every Day24.4.2026 02:20:00 CEST | Press release
Docusign, Okta, Tinder, Vercel, and Zoom bring World ID proof of human to businesses, AI agents, and consumers Last week, World announced the next generation of World ID, its proof of human protocol, designed to increase trust on the internet. The announcement was made during “Lift Off,” a live event in San Francisco. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260417530721/en/ Docusign, Okta, Tinder, Vercel, and Zoom bring World ID proof of human to businesses, AI agents, and consumers As AI makes it easier than ever to generate convincing content, identities, and interactions, trust online has decreased. World ID addresses this challenge by enabling individuals to privately prove they are a real, unique human, without revealing their identity across apps, platforms, and services. “If anything online can be faked, you no longer know who or what to trust,” said Tiago Sada, Chief Product Officer at Tools for Humanity, a co
Cognite Positioned as a Front Runner in LNS Research Solution Selection Matrix for Industrial AI Platforms23.4.2026 20:00:00 CEST | Press release
Cognite, the global leader in Industrial AI, has been named a Front Runner in the LNS Research Solution Selection Matrix for Industrial AI Platforms (SSM). The LNS Research SSM evaluates vendors using a rigorous methodology that leverages its “3P” framework—Product, Potential, and Presence—to assess both current capabilities and future readiness. Within the report, Cognite is recognized in three key areas: depth in user-centric industrial AI applications, its knowledge graph-based data model, and its strong partner ecosystem. Together, all three give Cognite the ability to unify and contextualize complex industrial data, enabling organizations to operationalize AI at scale. “Cognite brings a sophisticated data model built for industrial complexities, along with advanced analytics and AI-driven insights, which is crucial for industrial organizations to achieve meaningful productivity gains and enterprise-wide ROI,” said Vivek Murugesan, Research Analyst at LNS Research. “These capabilit
Venture Global Announces Closing of $750,000,000 Senior Secured Notes by Venture Global Calcasieu Pass, LLC23.4.2026 19:47:00 CEST | Press release
Venture Global, Inc. (“Venture Global”, NYSE: VG) announced today that its subsidiary, Venture Global Calcasieu Pass, LLC (“VGCP”) has closed an offering of $750,000,000 aggregate principal amount of 6.000% senior secured notes due 2036 (the “Notes”). The Notes will mature on May 1, 2036. VGCP used the net proceeds from the offering, together with cash on hand and proceeds received from certain hedge terminations, for the prepayment, in full, of VGCP’s outstanding term loans, and to pay fees and expenses in connection with the offering. The Notes are guaranteed by TransCameron Pipeline, LLC (VGCP’s affiliate). The Notes are secured on a pari passu basis by a first-priority security interest in the assets that secure VGCP’s existing senior secured first lien credit facilities and VGCP’s existing senior secured notes. The Notes were not registered under the Securities Act of 1933, as amended (the “Securities Act”) or the securities laws of any state or other jurisdictions, and the Notes
Does Muscle Composition Identify High-Risk Individuals in Chronic Kidney Disease? New AMRA Medical Study Says Yes, Reveals Strong Link to Mortality23.4.2026 17:10:00 CEST | Press release
AMRA Medical researchers recently set out to answer the question: what is the relationship between adverse muscle composition (AMC) and mortality in kidney disease? Recent findings demonstrate that AMC, characterized by low muscle volume z-score and high muscle fat infiltration, is an independent and strong predictor of all-cause mortality in individuals with chronic kidney disease (CKD). The findings, published in Clinical Journal of the American Society of Nephrology, were based on data from the UK Biobank imaging study and further reinforce the clinical relevance of MRI-derived muscle biomarkers in identifying high-risk populations across chronic diseases. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260423198497/en/ AMRA's MRI-based muscle biomarkers in clinical trials Researchers from AMRA, alongside our collaborators at Linköping University (LiU), analyzed 894 participants with CKD using AMRA’s MRI-based body composi
In our pressroom you can read all our latest releases, find our press contacts, images, documents and other relevant information about us.
Visit our pressroom