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).
In infectious disease research, most of the research into genetic determinants of susceptibility to infection and disease severity are focused on the host. For COVID-19, for example, the delta variant’s infectivity, and how likely infection is to lead to severe disease, is the focus of an intense research agenda. But host genetics, too, contribute to the consequences of infections. An ongoing study into the host genetics of SARS-CoV-2 infection has identified 13 such factors that affected either the likelihood of contracting SARS-CoV-2, or the severity of disease, gleaned from the data of 50,000 infected persons and 2 million controls.
Clinical updates, including trial initiations, enrollment status and data readouts and publications: Abeona, Alx, Eloxx, Epimab, Moderna, Nextcure, NGM, Nrx, Opiant, Stratatech, Tetherex, Trevena, Xenon.
A collaboration between Oncosec Medical Inc. and Merck and Co. that yielded positive phase II study data has paved the way for a phase III study between the two companies. Oncosec’s DNA-plasmid interleukin-12 (IL-12) Tavo (tavokinogene telseplasmid) will be combined with Merck's anti-PD-1 therapy Keytruda (pembrolizumab) in a randomized, global phase III study for treating late-stage metastatic melanoma.
Getting cell therapies to work against solid tumors is proving difficult – but two biopharma firms have begun early-stage studies with technologies that aim to crack this tough nut. Gadeta B.V. and Apeiron Biologics AG are using two different approaches to cell therapy that they hope will be effective against tough-to-treat solid tumors.
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