The U.K.’s Medicines and Healthcare Products Regulatory Agency (MHRA) joined the JAK inhibitor pile-on Oct. 6 with new measures to reduce the risk of major heart problems and malignancies in people taking Pfizer Inc.’s Xeljanz (tofacitinib).
Exo Therapeutics Inc. has completed an oversubscribed series B financing for $78 million allowing the small-molecule company to continue developing therapies for treating cancer and inflammation.
Exo’s pipeline, created from its Exosight platform, has preclinical candidates that bind exosites, which are distal binding pockets for reprogramming enzyme activity. The exosite drugs include structural and computational biology, protein engineering and DNA-encoded libraries.
European regulators have rejected Pfizer Inc.’s tanezumab, casting further doubts on whether the FDA will okay the troubled drug that is intended as a non-opioid alternative for osteoarthritis pain.
Replicate Bioscience Inc. secured a $40 million series A round to take a portfolio of preclinical projects employing self-replicating RNA into the clinic.
DUBLIN – Shares in Bone Therapeutics SA dropped by as much as 38% Aug. 30 after the regenerative medicine firm reported that its lead program, JTA-004, flopped in a phase III trial in osteoarthritis of the knee. The candidate therapy, designed to lubricate and protect damaged cartilage in affected joints, failed to meet the primary endpoint of being superior to placebo in reducing pain, as measured on the Western Ontario McMaster Universities Osteoarthritis Index (Womac) pain subscale three months after treatment.
Xalud Therapeutics Inc. raised an oversubscribed $30 million series C financing to continue advancing its lead candidate, XT-150, for regulating interleukin-10 in order to treat pathologic inflammation. The injectable, plasmid DNA gene therapy expresses IL-10v, a modified version of the cytokine IL-10, and is in a phase IIb study for treating moderate to severe pain caused by osteoarthritis (OA) of the knee.
CEO Samantha Singer said Abata Therapeutics Inc. “spent a considerable amount of time finding the right indication” for its approach, which deploys autologous regulatory T cells (Tregs) made to express T-cell receptors (TCRs). That disease is progressive, non-relapsing multiple sclerosis (MS). “We’re going to be able to succeed with these patients where other options have failed,” she told BioWorld.
The agreement between gout player Horizon plc and RNAi expert Arrowhead Pharmaceuticals Inc. could result in a subcutaneously given, infrequently dosed fix for the disease that takes aim at xanthine dehydrogenase. “They brought us the target – it wasn’t something we were developing,” said Arrowhead CEO Christopher Anzalone, but the Pasadena, Calif.-based firm’s research on hepatocyte-directed therapies provides confidence.
Morphosys AG is to acquire Constellation Pharmaceuticals Inc., financed by gambling a huge chunk of its income on the U.S. firm’s BET inhibitor pipeline drug – an approach that has to date produced mixed results in cancer.
With 10 cases of serious shock and anaphylaxis, including one death, in the month since Seikagaku Corp.’s osteoarthritis drug, Joyclu (diclofenac etalhyaluronate sodium), launched in Japan, the Pharmaceuticals and Medical Devices Agency (PMDA) issued a blue letter to health care professionals and is adding a warning section to the drug’s Japanese label.
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