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
Venture Global Announces Closing of $2.25 Billion of Senior Secured Notes11.6.2026 23:00:00 CEST | Press release
Venture Global LNG, Inc. (“Venture Global”) announced today that its wholly-owned subsidiary, Venture Global LNG, Inc. (the “Issuer”) has closed its offering of $1.125 billion aggregate principal amount of its 6.375% senior secured notes due 2034 (the “2034 Notes”) and $1.125 billion aggregate principal amount of its 6.625% senior secured notes due 2036 (the “2036 Notes” and, together with the 2034 Notes, the “Notes”). The Issuer used the gross proceeds from the offering to redeem all of the Issuer’s outstanding 8.125% senior secured notes due 2028 (the “Existing 2028 Notes”) and used cash on hand to pay the redemption premium and related fees and expenses for the offering and the redemption. The 2034 Notes will mature on December 15, 2034, and the 2036 Notes will mature on June 15, 2036. The Notes were issued at par. The Notes will initially not be guaranteed by any of the Issuer’s subsidiaries. In the future, certain of the Issuer’s subsidiaries that incur or guarantee certain amount
Venture Global and Atlantic-SEE Announce Expansion of Long-Term LNG Sales and Purchase Agreement with Greece11.6.2026 22:30:00 CEST | Press release
Deal doubles quantity of US LNG to be supplied by Venture Global, expanding existing partnership to bolster Central and Eastern European energy securityBuilds on Venture Global’s regasification capacity investment in the Alexandroupolis LNG import terminal to supply U.S. LNG to the region Today, Venture Global, Inc. (NYSE: VG) and ATLANTIC – SEE LNG TRADE S.A. of Greece announced an expansion of their existing Sales and Purchase Agreement (SPA) for the purchase of U.S. liquefied natural gas (LNG) from Venture Global for twenty years starting in 2030. Under the deal, Atlantic-SEE is doubling their existing contract with Venture Global from a minimum of 0.5 million tonnes per annum (MTPA) to 1.0 million tonnes per annum (MTPA). Atlantic-SEE LNG is a newly formed joint venture announced in November at the 6th Partnership for Transatlantic Energy Cooperation (PTEC) conference hosted in Athens, Greece between Greek companies AKTOR Group and DEPA Commercial. The announcement of this expanded
Merrithew® Expands Global Mindful Movement Leadership with Acquisition of the GYROTONIC® Organization11.6.2026 17:30:00 CEST | Press release
Strategic acquisition strengthens Merrithew International Inc.’s position as a leading global authority in mindful movement education, equipment, and wellness Merrithew®, a global leader in mindful movement education and equipment and creator of internationally recognized programs including STOTT PILATES®, ZEN•GA®, Halo® Training and Total Barre®, today announced the acquisition of the GYROTONIC® organization, creator of the globally respected GYROTONIC® and GYROKINESIS® methods. Founded by Juliu Horvath, the GYROTONIC® and GYROKINESIS® methods are internationally recognized for their distinctive approach to movement, combining fluidity, strength, mobility, coordination, and rehabilitation through specialized equipment and movement sequences. Practiced in studios and wellness centers worldwide, the methods have cultivated a deeply loyal global community of instructors, trainers, therapists, and movement professionals. The acquisition marks a significant milestone in Merrithew Internati
GigaDevice Expands Optical Communication Portfolio with New GD32E512 and GD32E252 Series MCUs for Optical Modules11.6.2026 16:00:00 CEST | Press release
GigaDevice, a leading semiconductor company specializing in Flash memory, 32-bit microcontrollers (MCUs), sensors, and analog products, has introduced the new GD32E512 and GD32E252 series MCUs specifically designed for optical module applications. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260611850679/en/ Empowering Optical Interconnect Innovation, GigaDevice Unveils Dedicated MCUs for Optical Modules. As a leading supplier of MCUs for optical module applications, GigaDevice has maintained a strong focus on the optical communication market, continuously aligning its product development with evolving industry requirements and next-generation optical interconnect technologies. Leveraging years of expertise in optical module control solutions, GigaDevice has established a strong position in the market through continuous innovation and close collaboration with industry partners. To further support the advancement of high-sp
Saudi Arabia at the Center of the Global Water Industry as IDWS 2026 Reshapes the Future of Water11.6.2026 15:47:00 CEST | Press release
In an increasingly resource-constrained world, water has become critical to both economic growth and national security, driving demand for global leadership in sustainability, innovation, and water solutions. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260611388456/en/ Saudi Arabia at the Center of the Global Water Industry as IDWS 2026 Reshapes the Future of Water (Graphic: AETOSWire) The Saudi Water Authority has announced the return of the Innovation Driven Water Sustainability Conference (IDWS), taking place from 7 to 9 December 2026 at The Ritz-Carlton, Jeddah, as the Kingdom consolidates its position at the center of the global water conversation. As home to one of the world’s most advanced and rapidly evolving water management ecosystems, Saudi Arabia currently operates more than 500 water production facilities across the Kingdom with total water production capacity exceeding 16.2 million cubic meters per day. The
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