The undrugged transcription factor interferon regulatory factor 5 (IRF5) is involved in autoimmune disorders such as Sjogren’s disease and rheumatoid arthritis in which dysregulation of IRF5 leads to autoantibody formation and secretion of pro-inflammatory cytokines, with type I interferon exacerbating inflammation. Totus Medicines Inc. has presented preclinical data regarding a novel IRF5 inhibitor for controlling autoimmune disorders.
Researchers from Elpiscience Biopharmaceuticals Inc. hypothesized that dual targeting of the TL1A/DR3 and IL-23 signaling pathways with a single bispecific antibody would exert superior efficacy by reshaping the immune landscape in disorders such as inflammatory bowel disease (IBD). The company has developed a bispecific antibody targeting both TL1A/DR3 and IL-23p19 – ES-302 – for the treatment of IBD.
Work at Trained Therapeutix Discovery Inc. has led to the development of new mammalian target of rapamycin (mTOR; FRAP1) inhibitors and high-density lipoprotein (HDL)-derived nanoparticles potentially useful for the treatment of autoimmune diseases, transplant rejection, inflammatory and cardiovascular disorders.
While most human papillomavirus (HPV) infections are cleared by the host immune system, persistent infection with high-risk HPV genotypes, particularly HPV16 and HPV18, can promote cervical cancer development. Researchers from Huazhong University of Science and Technology reported the development and preclinical characterization of KDTV-001, an HPV vaccine comprising a nonreplicating adenovirus type 5 vector encoding a codon-optimized fusion protein of the early antigens E6 and E7 derived from HPV genotypes 16, 18 and 52.
Pemphigus vulgaris (PV) is a life-threatening autoimmune disease affecting the skin, causing painful erosions on the skin and mucous membranes. PV is caused by IgG4 autoantibodies that target desmoglein 1 (DSG1) and DSG3, which are involved in keratinocyte cell-cell adhesion. There is a high unmet medical need for PV, since current therapies rely on systemic corticosteroids and immunosuppressants.
More than four decades on from the approval of the first biologic drug, the industry has reached a tipping point, and biotech drugs now outnumber small molecules in the global R&D pipeline. At the start of the biotech industry, progress was slow. Between 1983 and 1995, the U.S. FDA approved an average of two biologics each year. Now, biologics have taken the lead by the smallest of margins, accounting for 50.1% of drugs in development at the start of 2026, according to the Pharma Annual Review 2026, published by Pharmaprojects, a firm that tracks global pharma R&D.
Innovent Biologics Inc. has presented preclinical data on IBI-3055, a trispecific T-cell engager for the treatment of autoimmune diseases. This trispecific antibody targets CD19, BCMA and CD3, and features an innovative 1+1+1 T-cell engager design with CD3 masking to minimize non-specific T-cell activation.
The tumor necrosis factor (TNF)-α-induced protein 8-like 2 (TIPE2), predominantly expressed in bone marrow-derived cells or lymphoid tissues, is an essential regulator of immune homeostasis. TIPE2 acts as a key negative modulator of inflammatory signaling through the suppression of toll-like receptor (TLR) activity, with TIPE2-deficient mice exhibiting spontaneous systemic inflammation and premature death.
Invivyd Inc. has announced the discovery and advancement of VMS-063, a novel monoclonal antibody candidate for the treatment and prevention of measles.
Researchers from Singlomics Zhuhai Danxu Biopharmaceuticals Co. Ltd. presented DXP-006, a humanized antibody targeting IL1RAP, a shared co-receptor required for IL-1, IL-33 and IL-36 cytokines.