Optimism rose for what could be the first CAR T therapy in autoimmune disease as Kyverna Therapeutics Inc. made public a positive primary analysis from its registrational trial, KYSA-8, of mivocabtagene autoleucel (miv-cel, KYV-101) in stiff-person syndrome. Kyverna plans to submit a BLA to the U.S. FDA in the first half of this year.
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.
“Single drugs targeting single biological pathways are insufficient for complex diseases,” Remedy Cell Ltd. CEO Ayelet Dilion Mashiah told BioWorld. Remedy is taking a secretome-based approach to treat lung disorders, having moved its lead asset, RC-0315, into a first-in-human clinical trial for idiopathic pulmonary fibrosis (IPF) in January.
Biogen Inc. has consolidated full global rights to felzartamab through an $850 million deal with TJ Biopharma Co. Ltd. April 20, closing the chapter on a complex 10-year license saga.
“Single drugs targeting single biological pathways are insufficient for complex diseases,” Remedy Cell Ltd. CEO Ayelet Dilion Mashiah told BioWorld. Remedy is taking a secretome-based approach to treat lung disorders, having moved its lead asset, RC-0315, into a first-in-human clinical trial for idiopathic pulmonary fibrosis (IPF) in January. Secretomes refer to the collection of bioactive molecules secreted by cells in the extracellular space, including proteins, enzymes, growth factors and extracellular vesicles such as exosomes.
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.
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.
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.
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