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WEDNESDAY, July 10, 2024 -- Models can be constructed that predict cognitive decline using Mini-Mental State Examination (MMSE) scores over time for mild cognitive impairment (MCI) and mild dementia, according to a study published online July 10 in Neurology . Pieter J. van der Veere, M.D., from the VU University Medical Center in Amsterdam, and colleagues constructed clinically applicable prediction models of cognitive dementia in amyloid-positive patients with MCI or mild dementia from the Amsterdam Dementia Cohort. Linear mixed modeling was used to predict the MMSE over time. Data were included for 961 participants: 310 had MCI and 651 had mild dementia with 4 ± 2 MMSE measurements over two years. The researchers found that over time, there were increases in cognitive decline rates for both MCI and mild dementia. Backward selection retained age, sex, cerebrospinal fluid (CSF) β-amyloid (Aβ)1-42, and pTau as time-varying effects altering the MMSE trajectory for MCI. Time-varying effects of Aβ1-42, age, APOE ε4, and baseline MMSE were retained for mild dementia. In internal cross-validation, R 2 was 0.15 and 0.26 for the MCI and mild dementia models, respectively. For a hypothetical patient with MCI, a baseline MMSE of 28, and CSF Aβ1-42 of 925 pg/mL, an MMSE of 20 was predicted after 6.0 years and after 8.6 years with a hypothetical treatment. "There is a need among patients and care partners for prognostic information on their cognitive trajectory," the authors write. "These models can provide such information, although our results also emphasize that the heterogeneity in cognitive trajectories can only be partially captured." Several authors disclosed ties to the biopharmaceutical industry. Abstract/Full Text Whatever your topic of interest, subscribe to our newsletters to get the best of Drugs.com in your inbox.

JJP Biologics has received a positive conclusion on the Clinical Trial Application assessment for a Phase I Study of a potential first-in-class anti-CD89 antagonist, JJP-1212 monoclonal antibody for the treatment of various IgA-mediated autoimmune- and fibrotic diseases. WARSAW, Poland--(BUSINESS WIRE)-- 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 and join the #smartgoose community by following us on LinkedIn. For further information, please contact: Paweł Szczepański, COO, info@jjpbiologics.com. REFERENCES DISCLOSURE NOTICE We do not undertake any obligation to publicly update any forward-looking statements. View source version on businesswire.com: Contacts Paweł Szczepański, COO, info@jjpbiologics.com Source: JJP Biologics View this news release online at:

Press Release Stockholm, Sweden, December 4, 2023 Mendus AB (“Mendus” publ; IMMU.ST), a biopharmaceutical company focused on immunotherapies addressing tumor recurrence, today announced it will host a virtual KOL Event on December 14, 2023 at 9:00 AM ET, featuring Dr. Arjan van de Loosdrecht, Professor of Hematology at Amsterdam UMC and Principal Investigator of the ADVANCE II trial, who will discuss the current treatment landscape for patients with Acute Myeloid Leukemia (AML) and the development of Mendus’ lead product candidate vididencel as a potential AML maintenance therapy. To register, click here. The event will focus on the new survival data being presented at the American Society of Hematology (ASH) Annual Meeting, taking place December 9-12, 2023. The results will include relapse-free and overall survival data from the ongoing ADVANCE II monotherapy Phase 2 trial and immunomonitoring data. A live question and answer session will follow the formal presentations. About Dr Arjan van de LoosdrechtDr. Arjan van de Loosdrecht, Professor of Hematology at Amsterdam UMC, passed Medical School (cum laude) in 1989 at the VU University Medical Center in Amsterdam (VUmc), The Netherlands. After a 4th years scientific laboratory training in cell biology, immunology and hematology he received his PhD graduation (cum laude) in 1993 at the department of Hematology (VUmc) on the thesis; ‘Monocyte mediated cytotoxicity in acute myeloid leukemia; Mechanisms and clinical implications’. In 1995 he graduated in Immunology. From 1993-1998 he followed clinical training in Internal Medicine followed by a fellowship in hematology (Department of Internal Medicine and Hematology at the Groningen University Medical Center, Groningen, Netherlands). From 2000, he is a staff member, since 2009 an associate professor and since 2012 a full professor of hematology at the department of Hematology, Amsterdam UMC, location VUmc, Amsterdam. His particular scientific experiences and interests are on translational hematology. He is project leader/principal investigator of the preclinical and translational immunotherapy programs in myeloid leukemia (AML) and myelodysplastic syndromes (MDS). The major research lines focus on the immunopathogenesis of MDS/AML and on the development of leukemic dendritic cell vaccines for active specific immunization in patients with minimal residual disease (MRD) in AML and MDS. Since 2016 he is coordinator of HORIZON2020, AML-VACCiN program dealing with Dendritic Cell vaccination in AML and PI of the clinical program. He is project leader/principle investigator of clinical (translational) programs dealing with the treatment of low and high risk MDS. Regarding MDS, research focuses on the implementation of flow cytometry in the diagnosis, prognostication and monitoring of MDS. As such he is participant of the HORIZON2020 MDS-Right program. He is chair of the working group MDS of the Dutch Society of Cytometry on the implementation of flowcytometry in MDS and initiated a platform within the ELN on the implementation of flowcytometry in MDS in Europe. In addition, he is chair of the Database Sharing Committee of the International Working Group for Prognosis of MDS (IWG-PM) who developed the revised-IPSS for MDS.​ For more information, please contact:Erik Manting, CEOE-mail: ir@mendus.com ABOUT MENDUS AB (PUBL)Mendus is dedicated to changing the course of cancer treatment by addressing tumor recurrence and improving survival outcomes for cancer patients, while preserving quality of life. We are leveraging our unparalleled expertise in allogeneic dendritic cell biology to develop an advanced clinical pipeline of novel, off-the-shelf, cell-based immunotherapies which combine clinical efficacy with a benign safety profile. Based in Sweden and The Netherlands, Mendus is publicly traded on the Nasdaq Stockholm under the ticker IMMU.ST. http://www.mendus.com/ ABOUT VIDIDENCELVididencel is an off-the-shelf immunotherapy which is being developed as a cancer maintenance treatment, aimed at improving disease-free survival following first-line treatment. Vididencel is currently studied in a Phase 2 monotherapy trial in acute myeloid leukemia (AML) and a Phase 1 safety and feasibility trial in ovarian cancer. In December 2022, positive results from the ADVANCE II monotherapy Phase 2 trial in AML were presented at the American Society of Hematology (ASH) Annual Meeting. The analysis demonstrated the potential of vididencel to induce durable relapse-free survival in the majority of patients. Vididencel has received Orphan Drug Designation in Europe and the US and Fast Track Designation in the US for the treatment of AML. Mendus has secured a manufacturing alliance with NorthX Biologics for large-scale production of vididencel. Attachment 231204_Mendus KOL Event_ENG