Roivant Sciences Ltd. CEO Matt Cline said the firm’s unit Immunovant Inc. with FcRn blocker batoclimab has established “frankly a new bar” in myasthenia gravis (MG) as the New York-based firm reported top-line results from its phase III study and first data from period 1 of the phase IIb study with the same drug in chronic inflammatory demyelinating polyneuropathy. The data look promising, and Immunovant intends to use the findings to help advance second-generation FcRn prospect IMVT-1402 in both indications. Potentially registrational trials are planned. The U.S. FDA has granted IND clearance.
Oxford Biotherapeutics Ltd. is partnering with Roche AG to expand the current field of tumor antigens that can be drugged with antibodies, as part of a potential $1 billion-plus agreement. The agreement will see Oxford Biotherapeutics apply its membrane protein discovery platform to search for novel cancer cell antigens, which will be validated through the research collaboration, with Roche then taking the lead in advancing any resulting antibody programs.
Japanese-founded Regcell Inc. has raised $45.8 million and is redomiciling to the U.S. to accelerate clinical development of its pioneering regulatory T-cell (Treg) platform for autoimmune diseases and transplantation.
China’s National Medical Products Administration (NMPA) approved the country’s first injectable teprotumumab biosimilar from Innovent Biologics Inc. under the brand name of Sycume (teprotumumab N-01) to treat thyroid eye disease on March 14. The NMPA on March 15 accepted Simcere Pharmaceutical Group Ltd.’s NDA of deunoxavir marboxil (ADC-189) tablets, a product originally developed by Jiaxing Andicon Biotech Co. Ltd. to treat influenza A and B.
Leading pharma companies have pitched into Sofinnova Partners’ new accelerator fund, which has exceeded the target and closed at €165 million (US$180 million). In what is said to be the largest pan-European biotech accelerator fund, Amgen Inc., Bristol Myers Squibb Co. and Pfizer Ventures will get an inside track on startups formed around academic research, as the nascent companies are shaped up for formal investment rounds.
In atopic dermatitis, psoriasis and other dermatologic diseases, T cells lose tolerance to self-antigens, triggering the autoimmune response that leads to abnormal skin cell proliferation and inflammation. The use of Nck modulators may help correct dysregulated T-cell receptor (TCR) signaling, potentially restoring immune tolerance and reducing subsequent inflammatory responses.
Maxion Therapeutics Ltd. is poised to extend the therapeutic reach of antibodies into the vast field of G-protein coupled receptors and ion channel targets, after raising $72 million in a series A round.
Inflammatory bowel disease (IBD) is impacted by genetic, environmental and immunological factors, where the imbalance in T-cell immune responses significantly promotes its progression. In recent years, the role of RNA modifications in epigenetic regulation has caught significant attention in research; among these, N4-acetylcytidine (ac4C) is the only acetylation process in RNA and plays a role in several biological processes, but its implication in the functioning of immune cells is largely unknown to date.
A combination of Epstein-Barr virus (EBV) antibodies and genetic factors may be linked to an increased risk of multiple sclerosis (MS), according to a study led by scientists at Karolinska Institutet and Stanford University. “The Epstein-Barr virus has been a suspect for many years for having a role in causing MS. The evidence for it has increased though one has not really reached complete proof of its role,” Tomas Olsson told BioWorld.
Patients with psoriatic arthritis exhibit high levels of both IL-17A and IL-17F cytokines in the synovium. Bimekizumab, a biologic that targets both IL-17A and IL-17F, was recently approved for the treatment of plaque psoriasis and psoriatic arthritis.