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
New Visa Research Finds Consumer Trust is Accelerating the Path to Agentic Commerce9.9.2026 13:00:00 CEST | Press release
Consumers rank Visa as the most trusted brand to deliver AI-powered commerce. Visa (NYSE: V) today announced the Visa Trust Index for agentic commerce, providing new insight into how consumers are navigating the next evolution of AI shopping and payments. While consumers are increasingly using AI across the shopping journey, only 23% of U.S. consumers trust GenAI to handle payment transactions on their behalf. However, confidence in agentic commerce shifts when payments brands come into consideration. Visa emerged as the most trusted brand for AI-powered payments with 61% of respondents saying they would trust Visa to handle agentic transactions. The findings suggest that while consumers are intrigued by agentic commerce, trust remains the key factor determining whether adoption moves from possibility to reality. "AI has the potential to fundamentally reshape how people discover, buy and pay for goods and services, much like e-commerce and mobile commerce did before it," said Oliver Je
NIQ’s Optiq™ Goes Live in Discover, Expanding Access to Trusted Consumer Intelligence9.9.2026 12:45:00 CEST | Press release
Global beta rollout of NIQ’s Optiq Chat later this month will give more clients conversational access to explainable answers grounded in NIQ data and expertise NielsenIQ (NIQ), a leading consumer intelligence company, today announced that Optiq is now live within Discover, NIQ’s platform for accessing, analyzing and applying consumer and market intelligence, advancing the company’s strategy to make trusted consumer intelligence easier to access and apply. Where Ask Arthur introduced new ways to explore and analyze NIQ data through AI within Discover, Optiq expands that experience across conversational AI, mobile access and enterprise AI integrations, giving clients greater flexibility to access and apply NIQ intelligence across the applications and workflows where they make decisions. “AI models are becoming ubiquitous. Trusted intelligence is not,” said Irina Stoian, Chief AI Commercial Officer at NIQ. “That is why we are building the full system. Think of it like a body: harmonized N
Cegid and Silae Join Forces to Create a European Leader in AI-Driven Business Technology9.9.2026 12:32:00 CEST | Press release
Planned Merger Enables Trusted, Fully Integrated Experience Across E-Invoicing, Accounting, Tax, Payroll and HR, Digital Financial Services and Payments for Businesses and their PartnersChristian Pedersen Joins Cegid as CEO to Lead Combined Group Cegid, an AI-driven European leader in cloud business management software for small and medium-sized businesses (SMBs), and accounting professionals, and Silae, France’s leading payroll and human resources platform, today announced their intention to merge. The combination will create a national technology champion and the leading European technology platform for businesses and their partners, helping them grow safely and efficiently with the support of a fully integrated and compliant suite covering their end-to-end financial and administrative needs. Between them, Cegid, following its recent acquisition of Shine, and Silae power the day-to-day accounting, tax, finance and payroll of 2 million end-customers and more than 15,000 chartered acco
Compass Pathways’ New 52-Week Topline Open-Label Data from Phase 3 COMP005 Trial Demonstrates Additional Benefit from Another COMP360 Dose in Part C Extending Durability Out to 1 Year9.9.2026 12:30:00 CEST | Press release
Notable additional benefit observed with an added reduction in MADRS1 score leading to an average 13-point reduction from baseline at Week 52 with durability extended out to 1 year for participants who were randomized to the 25 mg arm and received an additional doseFor participants randomized to Placebo arm who received first dose of COMP360 25 mg in open-label Part C, data further reinforces that a single 25 mg dose can produce rapid onset, meaningful effect and durabilityFor all participants in Part C who received a 25 mg open-label dose, strong response and remission rates were observed with 40%-45% responders2 and approximately 30% remitters3 across all timepoints 6 weeks post the Part C doseThis 1-year data further supports the belief that, if approved, COMP360 could establish a new standard of care in TRD that can be life-changing for patients − moving beyond daily or frequent administration toward an option that could provide durable benefit with just a few treatments a yearCOMP
New ABB and BCG Report Highlights Growing Role of Direct Current Technologies in Future Power Systems9.9.2026 11:42:00 CEST | Press release
Rapid expansion of AI computing, increasing electrification and rise of renewable energy are driving renewed interest in DC technology as part of future electrical systems Both AC and DC systems have strategically important roles in meeting future electricity demand Establishing common standards and developing DC-specific skills can help accelerate deployment ABB today published a new report, The Strategic Case for Hybrid AC/DC Power: Shaping the Transition to the Next Electrical Architecture, developed in collaboration with Boston Consulting Group (BCG). The report makes the case that direct current (DC) technology is moving from the periphery to the center of industrial, commercial, and digital infrastructure – and that the decisions made by business leaders and policymakers in the next two to three years will determine who shapes that transition and who inherits it. The future of power distribution is not an either-or choice between alternating current (AC) and direct current, but a
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