Innocare Pharma Ltd. raised ¥2.92 billion (US$412 million) in a second listing on the Shanghai STAR Market. Its shares opened at ¥10.86 apiece, sliding 15.4% to close at ¥9.33 on the first trading day, Sept. 21. The company will use the proceeds to support cancer and autoimmune drug R&D, improve its drug development platform, build its sales network, and upgrade its information technology, said Chief Commercial Officer Jin Xiaodong.
DBV Technologies SA blindsided investors by disclosing that the U.S. FDA had placed a partial clinical hold on its phase III Vitesse trial of its Viaskin Peanut patch immunotherapy for peanut allergy, calling for several changes to the study protocol. Its demands came just two weeks after the company claimed to have finalized the protocol in consultation with the agency.
After an eight-year odyssey, the first cytidine triphosphate synthase 1 (CTPS1) inhibitor has entered the clinic, with Step Pharma SAS announcing it has simultaneously begun studies in the U.S. and the U.K. The phase I/II trial is assessing Step’s lead program, STP-938, in relapsed/refractory B- and T-cell lymphomas, with the first U.S. site opening for enrollment this week.
Microbiome specialist Enterome SA has out-licensed its lead human hormone mimetic, EM-1010, to Nestlé Health Sciences SA, in a deal that underlines the potential of its approach to generating novel drugs from proteins expressed by gut bacteria. EM-1010, the first program derived from Enterome’s Endomimics platform, is an orally available molecule that acts by promoting local release of interleukin 10 in the gut, with the aim of reducing inflammation. It is in development for the treatment of inflammatory bowel disease and food allergies and due to enter clinical trials in 2023.
Skyhawk Therapeutics Inc. has cut a deal with Sanofi SA to discover and develop small molecules to treat targets in oncology and immunology, adding to its lengthy list of partnerships.
Despite mostly positive data from the ongoing phase III study of Talaris Therapeutics Inc.’s lead asset, FCR-001, an allogeneic cell therapy for treating living donor kidney transplant patients, investors are stepping away. The Boston and Louisville, Ky.-based company’s stock took a hit June 20 as shares (NASDAQ:TALS) fell 36.7% to $4.51 each.
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.