Researchers from Genentech Inc. have developed a novel single-domain antibody (VHH) targeting the IL-23 signaling pathway, which can be administered orally to effectively treat inflammatory bowel disease in animal models.
In progressive fibrotic diseases, which can occur in nearly all organs, myofibroblasts are activated to differentiate into proliferating fibroblastic cells that express genes that lead to deposition of extracellular matrix. The factors driving myofibroblast activation appear to be varied and complex, ranging from mechanical insults to inflammation, infection and cancer.
The recent 8-1 adcom vote against the U.S. applicability of Genentech Inc.’s Starglo trial is being seen as a warning signal expanding beyond the confirmatory trial for Columvi (glofitamab) as a treatment for relapsed/refractory diffuse large B-cell lymphoma.
More telling than the U.S. FDA’s Oncologic Drugs Advisory Committee’s 4-5 vote May 21 on the overall benefit-risk of Urogen Pharma Inc.’s UGN-102 (mitomycin) is that the panel’s urology specialists and the patient representative all voted yes, saying the drug would be an important alternative to what is often a continuing cycle of surgery for patients with recurrent low-grade intermediate-risk non-muscle invasive bladder cancer.
Orionis Biosciences Inc. is sticking with Genentech Inc. in a second deal to discover small-molecule monovalent glue therapies for treating cancer. Privately held Orionis is getting $105 million up front and could earn more than $2 billion in R&D, development, commercial and net sales milestones, plus royalties. The multiyear collaboration calls for Orionis to handle discovery and optimization of molecular glues, with Genentech in charge of later-stage preclinical and clinical development, regulatory filing and commercialization of any small molecules the partnership produces.
With a PDUFA date less than four weeks away, Urogen Pharma Inc. has been having a rough ride on the Street since the U.S. FDA released a joint briefing document for the May 21 Oncologic Drugs Advisory Committee meeting on UGN-102 (mitomycin).
Repertoire Immune Medicines Inc. has entered into a collaboration and license agreement with Genentech Inc., a member of the Roche Group, to discover and develop innovative T cell-targeted immune medicines to treat an autoimmune disease. Repertoire will use its Decode platform, which maps the immune synapse, to discover novel therapeutic targets.
The U.S. FDA issued a complete response letter in October 2023 for Dupixent (dupilumab) in treating chronic hives but has now approved the monoclonal antibody for the indication. The approval makes Dupixent the first targeted biologic the agency has approved in the past 11 years for chronic spontaneous urticaria.
Convelo Therapeutics Inc. and Genentech Inc. have identified lanosterol 14α-demethylase (CYP51A1; CYP51) inhibitors reported to be useful for the treatment of multiple sclerosis, encephalomyelitis, optic neuritis, schizophrenia, amyotrophic lateral sclerosis, Alzheimer’s disease, Parkinson’s disease and Huntington’s disease, among others.
