UZ Leuven

New International Study Reports Extension of the Donor Lung Transplantation Window

Retrieved on: 
Tuesday, March 12, 2024
FDA, Surgery, Medical Devices, Hospitals, Health, Clinic, Temperature, UZ Leuven, Transplant, Massachusetts General Hospital, Assistant, Motol University Hospital, Risk, Patient, Transport, Lung transplantation, Surgeon, Thorax, Ice, Dentistry

This milestone publication lays a strong foundation for future clinical applications in organ preservation and transplantation.

Key Points: 
  • This milestone publication lays a strong foundation for future clinical applications in organ preservation and transplantation.
  • For example, presenting a means to better accommodate longer transportation times, overnight bridging, or optimizing case scheduling during the day.
  • During the six-month study period, the LUNGguard® Donor Lung Preservation System was utilized to preserve donor lungs for over 15 hours in 13 separate instances.
  • Longer ischemic times increase the risk of primary graft dysfunction, a serious complication that can occur after lung transplantation.

Biogen’s QALSODY® (tofersen), the First Therapy to Treat Rare, Genetic Form of ALS, Received Positive Opinion from CHMP

Retrieved on: 
Friday, February 23, 2024
Fever, European Commission, EMA, ALS, Committee, MND, Myalgia, Intracranial pressure, BIIB, Cerebrospinal fluid, Pain, Hope, Biogen, European, SOD1, Arthralgia, Civil service commission, Biomarker, Fatigue, CHMP, AFL, European Medicines Agency, Protein, Disease, UZ Leuven, Mutation, Myelitis, Neurology, Aseptic meningitis, Research, Chronic pain, Vaccine

If authorized by the European Commission (EC), QALSODY will be the first treatment approved in the European Union to target a genetic cause of ALS, also known as motor neuron disease (MND).

Key Points: 
  • If authorized by the European Commission (EC), QALSODY will be the first treatment approved in the European Union to target a genetic cause of ALS, also known as motor neuron disease (MND).
  • “The CHMP’s positive opinion reinforces the impact QALSODY can have in SOD1-ALS and further demonstrates Biogen’s commitment to address the unmet needs of people living with ALS and neuromuscular diseases,” said Priya Singhal, M.D., M.P.H., Head of Development at Biogen.
  • Trends towards improvement in the physical abilities of participants who received QALSODY were seen compared to those who received placebo, as measured by the ALS Functional Ratings Scale-Revised (ALSFRS-R).
  • Serious neurologic events, including myelitis and/or radiculitis; papilledema and elevated intracranial pressure; and aseptic meningitis have also been reported.

Landos Biopharma to Present New Data on Immunometabolism at the 19th Annual Congress of the European Crohn’s and Colitis Organisation

Retrieved on: 
Monday, January 8, 2024
Human, Treatment, Chronic pain, Homeostasis, PLXDC2, Ulcer, Disease, UC, Doctor of Philosophy, ECCO, Pharmacokinetics, NLRX1, Abstract, UZ Leuven, Library, Congress, European, Effect, Inflammatory Bowel Diseases, Inflammation, Patient, Translation, Immunometabolism, Safety, Landos, NEXUS, Pharmaceutical industry

The abstracts highlight new and additional data on immunometabolism modulation by activating NLRX1 and PLXDC2 with novel agonists such as NX-13 and LABP-69.

Key Points: 
  • The abstracts highlight new and additional data on immunometabolism modulation by activating NLRX1 and PLXDC2 with novel agonists such as NX-13 and LABP-69.
  • The ECCO congress will take place February 21-24, 2024 in Stockholm, Sweden.
  • We are excited to present data from multiple studies including the impact of NX-13 on eosinophil infiltration and visceral hypersensitivity, as well as confirming its relevancy in multiple models and species.
  • Additionally, we are pleased to share new preclinical insights into the potential role of PLXDC2 in ulcerative colitis,“ said Fabio Cataldi, M.D., Executive Vice-President & Chief Medical Officer at Landos.

International Consortium Publishes Comprehensive Roadmap for the Clinical Implementation of OGM in Hematological Malignancy Applications

Retrieved on: 
Wednesday, January 3, 2024
Consortium, OGM, SVS, Radboud University Medical Center, Workflow, University, Bone marrow, Quality control, Blood, University of Oulu, SAN, Columbia University, Laboratory, LDT, UZ Leuven, MD Anderson Cancer Center, Biomarker, University of Toronto, University Health Network, Algorithm, Medical device

The authors believe that a proactive approach to the development of standards would be beneficial for global laboratories’ understanding of how best to use an OGM workflow.

Key Points: 
  • The authors believe that a proactive approach to the development of standards would be beneficial for global laboratories’ understanding of how best to use an OGM workflow.
  • Consortium members collaboratively outlined a consensus framework designed to provide guidance to laboratories interested in the adoption and implementation of OGM.
  • The authors covered considerations that need to be addressed when incorporating OGM into a laboratory, including assessment of clinical utility, proof of principle study, method validation, clinical validation, and implementation.
  • The framework addresses these considerations with specific recommendations in three areas: validation, quality control, and analysis and interpretation of variants.

Landos Biopharma Provides Company Update and Reports Third Quarter 2023 Results

Retrieved on: 
Thursday, November 9, 2023
Research, United European Gastroenterology, American College, NLRX1, UC, D&O, Biomarker, NEXUS, ACG, Wind, American College of Gastroenterology, D, Poster, Ulcerative colitis, Inflammatory bowel disease, LTE, UZ Leuven, KU Leuven, Pharmacokinetics, Clinical trial, Epithelium, Ulcer, Safety, Patient, Gene expression, Pharmaceutical industry

NEW YORK, Nov. 09, 2023 (GLOBE NEWSWIRE) -- Landos Biopharma, Inc. (NASDAQ: LABP), a clinical-stage biopharmaceutical company developing novel, oral medicines for patients with autoimmune diseases, today provided a business update and announced financial results for the quarter ended September 30, 2023.

Key Points: 
  • NEW YORK, Nov. 09, 2023 (GLOBE NEWSWIRE) -- Landos Biopharma, Inc. (NASDAQ: LABP), a clinical-stage biopharmaceutical company developing novel, oral medicines for patients with autoimmune diseases, today provided a business update and announced financial results for the quarter ended September 30, 2023.
  • NEXUS Phase 2 proof-of-concept clinical trial:
    The NEXUS trial of NX-13 remains on track as the Company continues to recruit, screen and randomize patients for the trial.
  • Research and development expenses were $3.1 million for the third quarter of 2023, compared to $4.9 million for the third quarter of 2022.
  • General and administrative expenses were $2.1 million for the third quarter of 2023, compared to $3.0 million for the third quarter of 2022.

IDRx Presents Preliminary Clinical Data from Ongoing Phase 1 StrateGIST Study at CTOS 2023 Supporting Best-in-Class Potential of IDRX-42 in Patients with GIST

Retrieved on: 
Thursday, November 2, 2023
Oncology, Health, Clinical Trials, Research, Science, Pharmaceutical, Biotechnology, TKI, Patient, KIT, PRS, MTD, MPH, Physician, BID, Exon, Poster, Strategist, UZ Leuven, Annual general meeting, GIST, RECIST, Stromal cell, Therapeutic index, Pharmaceutical industry, MD

“Importantly, these preliminary data will help guide our discussions with physicians regarding development strategies for IDRX-42 in patients with GIST in early lines of therapy to prevent the emergence of genomically-driven resistance mutations.

Key Points: 
  • “Importantly, these preliminary data will help guide our discussions with physicians regarding development strategies for IDRX-42 in patients with GIST in early lines of therapy to prevent the emergence of genomically-driven resistance mutations.
  • Median duration on treatment was 16 weeks and continuing, with 70% (23/33) of patients remaining on treatment at time of data cutoff.
  • 4/28 patients are on study for
  • Title: Phase 1 Study of IDRX-42 in Patients with Advanced Gastrointestinal Stromal Tumors Resistant to Prior Systemic Therapy: Early Results
    Session: CTOS Poster Reception 5:30-6:30 p.m. GMT, Thursday, November 2nd

F2G and Shionogi Present Full Data Set from Pivotal Phase 2b Study at Trends in Medical Mycology (TIMM) 2023 Demonstrating Positive Therapeutic Responses in Patients with Invasive Fungal Infections Treated with Oral Olorofim

Retrieved on: 
Saturday, October 21, 2023
Standard of care, TIMM, Immunodeficiency, Congress, MD, EORTC, Doctor of Philosophy, Fungus, Research, Coccidioidomycosis, DRC, Shionogi, UZ Leuven, Hematology, OASIS, Scopulariopsis, World Health Organization, Risk, Antifungal, Medical Mycology, ACM, Fungal infection, Goodyear F2G Corsair, Patient, Infection, Birth control, Pharmaceutical industry, Coccidioides, F2G

These findings were submitted as a late breaking abstract and exceptionally accepted for an oral presentation during the 11th Congress on Trends in Medical Mycology (TIMM) 2023 held in Athens, Greece, from 20-23 October 2023.

Key Points: 
  • These findings were submitted as a late breaking abstract and exceptionally accepted for an oral presentation during the 11th Congress on Trends in Medical Mycology (TIMM) 2023 held in Athens, Greece, from 20-23 October 2023.
  • F2G and Shionogi & Co., Ltd. are collaborating to develop and commercialise olorofim, bringing the novel antifungal therapy to patients with invasive fungal infections.
  • F2G has commercial responsibility for olorofim in North America, and Shionogi has commercial responsibility for olorofim in Europe and Asia Pacific.
  • F2G and Shionogi are currently enrolling patients with invasive aspergillosis in a global Phase 3 study (OASIS) to compare treatment with olorofim versus AmBisome® followed by standard of care ( NCT05101187 ).

Landos Biopharma to Present New Data on NX-13 from Phase 1b Trial in Ulcerative Colitis at United European Gastroenterology (UEG) Week 2023 Congress

Retrieved on: 
Tuesday, September 19, 2023
IBD, Icahn School of Medicine at Mount Sinai, UEG, Biomarker, Guanine nucleotide exchange factor, NEXUS, Clinical trial, UC, Patient, NLRX1, UZ Leuven, Congress, Pharmaceutical industry, Book, Music, Ulcerative colitis, KU Leuven, Medicine

NEW YORK, Sept. 19, 2023 (GLOBE NEWSWIRE) -- Landos Biopharma, Inc. (NASDAQ: LABP), a clinical-stage biopharmaceutical company developing novel, oral medicines for patients with autoimmune diseases, today announced presentation of new data on the rapid symptomatic relief and improvement in multiple clinical biomarkers observed with NX-13 in its Phase 1b study in UC at the upcoming UEG Week 2023 congress in Copenhagen, Denmark and virtually from October 13 to October 17, 2023.

Key Points: 
  • NEXUS Phase 2 Clinical Trial is Ongoing; Top-line Readout Expected in Q4 2024
    NEW YORK, Sept. 19, 2023 (GLOBE NEWSWIRE) -- Landos Biopharma, Inc. (NASDAQ: LABP), a clinical-stage biopharmaceutical company developing novel, oral medicines for patients with autoimmune diseases, today announced presentation of new data on the rapid symptomatic relief and improvement in multiple clinical biomarkers observed with NX-13 in its Phase 1b study in UC at the upcoming UEG Week 2023 congress in Copenhagen, Denmark and virtually from October 13 to October 17, 2023.
  • “We are excited to have the innovative work of the Landos team and our collaborators selected for two oral presentations and one poster presentation at UEG Week - one of the top gastroenterology congresses in the world,” said Gregory Oakes, President and CEO of Landos.
  • “We believe this data continues to strengthen the scientific and clinical foundation for NX-13 and its novel, bimodal mechanism of action targeting NLRX1.
  • First, by showing rapid symptomatic relief to patients as early as two weeks; and second, by demonstrating improvement in multiple biomarkers that correlate with early endoscopic response.

Landos Biopharma Announces Strategic Research Collaboration with KU Leuven and University Hospitals Leuven to Further Characterize the Effects of NX-13 on Epithelial Cells

Retrieved on: 
Thursday, September 14, 2023
IBD, Epithelium, Clinical trial, Landos, Research, Gene expression, Inflammation, Ulcerative colitis, NEXUS, Patient, UZ Leuven, Inflammatory bowel disease, Environment, KU Leuven, NLRX1, Pharmaceutical industry, UC

The NEXUS Phase 2 proof-of-concept clinical trial of NX-13 in patients with moderate-to-severe ulcerative colitis (UC) was initiated during the second quarter of 2023.

Key Points: 
  • The NEXUS Phase 2 proof-of-concept clinical trial of NX-13 in patients with moderate-to-severe ulcerative colitis (UC) was initiated during the second quarter of 2023.
  • Recruitment, screening and randomization of patients continues, with top-line results on track for the fourth quarter of 2024.
  • The results are expected to provide further insight into the impact of NX-13 on gene expression and regulation, and cytokine responses.
  • Landos expects to present results from this research collaboration at appropriate medical conferences in 2024.

CareDx Advances Global Transplant Patient Care at ESOT Congress 2023

Retrieved on: 
Thursday, September 14, 2023
Biotechnology, Surgery, Hospitals, Health, Clinical Trials, Abstract, DNA, Paris Institute for Advanced Study, Comparison, Nucleic acid thermodynamics, Transplant, Doctor of Philosophy, Necker–Enfants Malades Hospital, Organ transplantation, Teaching hospital, University Hospital of Zürich, Associate, Congress, Plasma, Lung transplantation, Nephrology, Local, MD, Patient, Risk, Medical University of Vienna, UZ Leuven, Harbin Medical University, Paris, European Society for Primary Immunodeficiencies, Caregiver, Dentistry, Medical device, Epidemiology

CareDx, Inc. (Nasdaq: CDNA) – The Transplant Company™ focused on the discovery, development, and commercialization of clinically differentiated, high-value healthcare solutions for transplant patients and caregivers – today announced a leading presence at the 2023 European Society for Organ Transplantation (ESOT) Congress taking place September 17-20, 2023, in Athens, Greece.

Key Points: 
  • CareDx, Inc. (Nasdaq: CDNA) – The Transplant Company™ focused on the discovery, development, and commercialization of clinically differentiated, high-value healthcare solutions for transplant patients and caregivers – today announced a leading presence at the 2023 European Society for Organ Transplantation (ESOT) Congress taking place September 17-20, 2023, in Athens, Greece.
  • CareDx is hosting an educational symposium for medical professionals demonstrating the clinical utility of AlloSeq cfDNA.
  • “We are proud to attend ESOT Congress 2023, a preeminent European transplant conference, and share the latest data demonstrating the use of AlloSeq cfDNA,” said Reg Seeto, CEO and President of CareDx.
  • CareDx will review the latest data on AlloSeq cfDNA during an ESOT Congress 2023 Industry Satellite Symposium titled, “Adopting dd-cfDNA for Solid Organ Surveillance: Raising the Standards of Transplant Care.” The symposium will be held live and streamed virtually on ESOT’s Congress platform on Sunday, September 17, 2023.