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The U.S. FDA has accepted Mesoblast Ltd.’s BLA resubmission for its allogeneic stem cell treatment remestemcel-L in children with steroid-refractory acute graft-vs.-host disease (SR-aGVHD). Mesoblast received a complete response letter from the FDA in October 2020 for remestemcel-L even though approval was highly anticipated after the FDA’s Oncologic Drugs Advisory Committee voted 9-1 that the stem cell therapy showed evidence of efficacy as a treatment for SR-aGVHD in children.
Swiss orphan biotech AB2 Bio Ltd. has completed enrollment in a pivotal phase III trial for its recombinant interleukin-18-binding protein drug tadekinig alfa for an inherited form of the ultra-rare condition hemophagocytic lymphohistiocytosis that results from an excess of the pro-inflammatory cytokine IL-18.
The U.S. FDA has accepted Mesoblast Ltd.’s BLA resubmission for its allogeneic stem cell treatment remestemcel-L in children with steroid-refractory acute graft-vs.-host disease (SR-aGVHD). Mesoblast received a complete response letter from the FDA in October 2020 for remestemcel-L even though approval was highly anticipated after the FDA’s Oncologic Drugs Advisory Committee voted 9-1 that the stem cell therapy showed evidence of efficacy as a treatment for SR-aGVHD in children.
Modex Therapeutics Inc., an Opko Health Inc. company, has entered into an exclusive worldwide license and collaboration agreement with Merck & Co. Inc., for the development of MDX-2201, Modex's preclinical nanoparticle vaccine candidate targeting Epstein-Barr virus (EBV).
Autoantibodies are typically not good news. But a group of researchers from Bellinzona, Switzerland, have observed that the presence of autoantibodies against chemokines, a special class of cytokines, is associated with mild disease and less risk of developing long COVID. “Our hypothesis was that antibodies to chemokines, if they existed, would also be associated with a negative outcome of the disease. But, what we found, in fact, was the exact opposite of what we were predicting,” Davide Robbiani, director of the Institute for Research in Biomedicine, told BioWorld.
Bacteria inflaming the meninges have developed an immunosuppressive mechanism that contributes to their ability to attack the brain. Researchers found that, by activating pain receptors (nociceptors) to release chemical substances that block an immune cell receptor, Streptococcus pneumoniae and Streptococcus agalactiae deactivated the protective function of macrophages and weakened brain defenses. This, in turn, enabled them to invade the brain.
Allogeneic mesenchymal stromal cell (MSC) therapy is well tolerated in patients with graft-vs.-host disease (GVHD) but results in clinical trials have shown that it lacks potent immunosuppressive effects. Researchers from the Mayo Clinic thus proposed enhancing MSC immunosuppression by bioengineering the first chimeric antigen receptor (CAR) MSCs (CAR-MSCs) and targeting E cadherin (anti-Ecad CAR-MSC), with a CD28 intracellular signaling domain to induce antigen-specific immunosuppressor effect.
Primary sclerosing cholangitis (PSC) is a rare chronic and progressive autoimmune bile duct disease that is strongly associated with several immune-mediated disorders, the shared etiology and underlying characteristics of which is not completely understood. Researchers from Baylor College of Medicine investigated the shared genetic architecture of PSC with a variety of clinical and epidemiological traits and aimed to identify new lead PSC risk-associated loci.
Even its name is a testament to how enigmatic the tingible macrophage has been. Tingible, which means stainable, certainly gives no clues to its functions – but was, at least, one thing that was known about the cells. Now, scientists at the Garvan Institute of Medical Research have tracked the lifecycle and function of tangible macrophages in the lymph nodes, with implications for understanding autoimmune disorders, which are still poorly understood. Published March 2, 2023, in the journal Cell, the study highlights intravital imaging techniques the scientists used to observe how macrophages formed within the lymph nodes and how they behaved in real time.
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