Tolerance Bio Inc. and Zipcode Bio have established a strategic research and development collaboration aimed at pioneering novel delivery methods for targeted thymus therapeutics.
Biogen Inc.’s IND application for BIIB-142 has been accepted by the FDA. BIIB-142 is a degrader of IRAK-4 that Biogen intends to explore for therapeutic use in patients with autoimmune diseases.
Onco3r Therapeutics BV has obtained clinical trial application (CTA) approval by the Belgian regulatory authorities for its SIK3 inhibitor O3R-5671. A first-in-human trial will be conducted in Belgium and is expected to open enrollment in the coming weeks. Final data are expected in the first half of next year and will inform subsequent patient trials across a range of autoimmune diseases, which are planned to commence next year.
Enlaza Therapeutics Inc. will take charge of research through nominating candidates in its potentially $2 billion-plus deal with Vertex Pharmaceuticals Inc. For its efforts, Enlaza is getting $45 million in an up-front payment and equity investment, plus the opportunity to bring in more than $2 billion in research, development, regulatory and commercial milestones and tiered royalties on net sales.
Enlaza Therapeutics Inc. will take charge of research through nominating candidates in its potentially $2 billion-plus deal with Vertex Pharmaceuticals Inc. For its efforts, Enlaza is getting $45 million in an up-front payment and equity investment, plus the opportunity to bring in more than $2 billion in research, development, regulatory and commercial milestones and tiered royalties on net sales.
Novartis AG’s monoclonal antibody, ianalumab, has notched back-to-back wins, one in treating Sjögren’s disease and the other for primary immune thrombocytopenia (ITP). In Sjögren’s, which has no U.S. FDA-approved treatment, the phase III Neptunus-1 and Neptunus-2 studies are the first phase III trials to prompt statically significant reductions in adults with the autoimmune disease. In ITP, a disease that has yet to see a cure, top-line data of a phase III study of ianalumab combined with eltrombopag stretched to the time to treatment failure compared to placebo, the primary endpoint showing the maintenance of safe platelet levels.
Bristol Myers Squibb Co. has prepared and tested proteolysis targeting chimera (PROTAC) compounds comprising an E3 ubiquitin ligase-binding moiety coupled to interleukin-1 receptor-associated kinase 4 (IRAK-4) targeting moiety through a linker reported to be useful for the treatment of autoimmune diseases and inflammatory disorders.
Immunitas Therapeutics Inc. has revealed preclinical data supporting development of its potentially first-in-class, fully human anti-CD161 antibody, IMT-380. CD161-expressing T-cell subsets have been implicated in autoimmune diseases due to their production of inflammatory cytokines and presence in inflamed tissues.
Orbital Therapeutics Inc. has presented preclinical results supporting the development of OTX-201, a potential best-in-class in vivo CAR T therapy that comprises an optimized circular RNA encoding a CD19-targeted CAR delivered via targeted lipid nanoparticles.
Interferon regulatory factor 5 (IRF5) is a transcription factor activated downstream of Toll-like receptors (TLRs) 7, 8 and 9, and is predominantly expressed in dendritic cells, B cells, monocytes and macrophages. Once considered an undruggable target, IRF5 is now recognized as a key regulator of innate immunity, driving the production of type I interferons, pro-inflammatory cytokines and autoantibodies.
