Europe’s clinical trial registry is a mess with patchy and incomplete data, according to a scathing review of the system from researchers based at the U.K.’s University of Oxford, who hope that a revamp at the end of the year could improve matters.
DUBLIN – Inotrem SA has received €45 million (US$53 million) in public funding commitments to move its Trem-1 inhibitor, nangibotide, into a phase II/III trial in COVID-19 patients who are critically ill and on ventilation.
Riding high on dramatic phase Ib results with KIT receptor-binding monoclonal antibody CDX-0159 in urticaria (hives), Celldex Therapeutics Inc. plans to begin phase II work in the first half of next year. Shares of Hampton, N.J.-based Celldex (NASDAQ:CLDX) closed July 12 at $40.67, up $8.26, or 25%, as Wall Street reacted to favorable data from the trial in antihistamine-refractory cold urticaria and symptomatic dermographism, the two most common forms of chronic inducible urticaria (CindU).
Officials at Sigilon Therapeutics Inc. declined to comment beyond a press release on the FDA’s clinical hold for the phase I/II study with encapsulated cell therapy SIG-001 for severe or moderately severe hemophilia A. Shares of Cambridge, Mass.-based Sigilon (NASDAQ:SGTX) closed at $6.90 on July 9, down $2.34, or 25% after Wall Street learned of the regulatory move, which came because one of three patients treated has developed inhibitors to factor VIII (FVIII).
Fresh from showcasing preliminary evidence for the tolerability and potential benefits of its anti-CD137 monoclonal antibody, LVGN-6051, at the American Society of Clinical Oncology’s annual meeting in June, Lyvgen Biopharma Holdings Co. Ltd. is gearing up to move its CD40 agonist LVGN-7409 to clinical trials in China after initial U.S. patient dosing.
Aicuris Anti-Infective Cures AG is beginning the pivotal phase III part of its trial of pritelivir for herpes simplex virus infection after an encouraging midstage readout.
Recent findings with the sodium glucose transporter-2 inhibitor Jardiance (empagliflozin) from Boehringer Ingelheim International GmbH and Eli Lilly and Co. drew more attention to the cardiovascular space.
DUBLIN – Shares in Oncopeptides AB dropped 26% July 8 on news that the FDA had placed a partial clinical hold on a raft of trials involving its newly approved multiple myeloma drug Pepaxto (melphalan flufenamide; melflufen), following a bizarre incident involving the incomplete handover to an independent review committee of data from a phase III head-to-head trial in myeloma, which had pitted melflufen against Pomalyst (pomalidomide).
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