The U.S. FDA has put five phase III studies of Sanofi SA’s potential multiple sclerosis and myasthenia gravis blockbuster tolebrutinib on partial clinical hold after several cases of liver injury were identified after exposure to the drug. Sanofi said new recruitment in the U.S. is paused and participants who have been part of the trial for fewer than 60 days should stop taking tolebrutinib, although those taking the drug for longer can continue.
Mirobio Ltd. is poised to take two checkpoint agonists into the clinic in the treatment of autoimmune diseases, after closing a $97 million series B round. The most advanced program, MB-272, is an agonist of the B and T lymphocyte attenuator receptor that relays inhibitory signals to suppress the immune response. Mirobio says activating it has a “far reaching” regulatory effect, restoring self-tolerance across several major autoimmune diseases, including lupus.
Priovant Therapeutics Inc. is the newest of the Vants, a creature of Roivant Sciences Ltd., of Basel, Switzerland and Pfizer Inc. Established in September 2021, Priovant is developing brepocitinib, a tyrosine kinase 2 and JAK1 inhibitor for treating multiple highly inflammatory autoimmune diseases.
Novartis AG is not going quietly into the night after the U.S. Court of Appeals for the Federal Circuit reversed itself, invalidating a method patent covering a dosing regimen for the company’s blockbuster multiple sclerosis drug, Gilenya (fingolimod). After the split opinion came down June 21 from the three-judge panel, Novartis said it planned to file a petition seeking further review of the decision by the full court.
Meta Pharmaceuticals Inc. has raised $15 million in seed and pre-series A rounds in six months for the pipeline and AI platform development. Shenzhen, China-based Meta Pharma plans to use the new funds to support its three candidates to enter clinical trials, as well as the development of its Meta-map platform for pipeline expansion.
In August 2020, it looked like DBV Technologies SA was in considerable trouble after the U.S. FDA served it with a rejection for its Viaskin Peanut allergy patch, raising concerns efficacy could be compromised because the product wasn’t sticking to the skin well. But could the Montrouge, France-based firm be making a comeback with the epicutaneous technology?
Affibody AB and its development partners, Acelyrin Inc. and Inmagene Biopharmaceuticals Co. Ltd., are accelerating plans to move the interleukin-17A inhibitor izokibep (formerly ABY-035) into phase III studies in psoriatic arthritis following better-than-expected phase II efficacy combined with an apparently clean safety profile.
Poor phase II top-line data for Immunic Inc.’s lead candidate, vidofludimus calcium (IMU-838) hammered the stock June 2 as the study of the selective oral DHODH inhibitor missed its primary endpoint of clinical remission in treating moderate to severe ulcerative colitis. The failure means Immunic won’t pursue a phase III study on its own in the indication, but it won’t affect the company’s planned phase III studies of IMU-838 in treating relapsing multiple sclerosis (MS) and a phase II in treating progressive MS.
Elasmogen Ltd. has secured a “transformational” £8 million (US$10 million) in new funding with which to move its shark-based, antibody-like constructs toward the clinic.
As the six-month interim analysis of phase II data for ATA-199 in progressive forms of multiple sclerosis (MS) nears, investors in Atara Biotherapeutics Inc. – not to mention patients – are growing more intrigued by the prospect, an off-the-shelf T-cell candidate that targets Epstein Barr virus-infected B cells and plasma cells in the central nervous system.
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