LONDON – Four decades of academic research at the University of California, San Francisco, is to be translated through to the clinic with funding from a €1 million (US$1.2 million) European Commission grant. The money, awarded to a Dutch/German consortium will fund the generation and optimization of antibodies designed to neutralize oxidized phospholipids that mediate inflammatory changes in a swathe of diseases. The consortium that won the Eurostars award is led by Oxitope Pharma BV.
Mozart Therapeutics Inc. CEO Katie Fanning said the firm’s $55 million series A financing will allow the filing of an IND, probably in early 2024, for a prospect in celiac disease. Founded in July 2020, Seattle-based Mozart is based on research into the CD8 T-cell regulatory network, which has been found to play an important role in surveillance, recognition and elimination of inappropriately activated autoreactive and pathogenic immune cells.
Pacira Biosciences Inc. will add to its core non-opioid-based therapies business by buying Flexion Therapeutics Inc. for $427 million. That brings into the company’s fold Zilretta (triamcinolone acetonide extended-release injectable suspension) for treating osteoarthritis knee pain, an injectable non-opioid that’s already FDA approved in addition to being in a phase II study for treating shoulder osteoarthritis.
Less than two weeks after Japan’s MHLW became the first regulatory agency to clear avacopan for anti-neutrophil cytoplasmic autoantibody (ANCA)-associated vasculitis, the FDA has followed suit. It cleared the oral, small-molecule C5aR antagonist for use as an adjunct therapy for adults with the two main forms of the rare autoimmune renal disease, granulomatosis with polyangiitis and microscopic polyangiitis, in combination with standard therapy.
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.
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