The lack of data surrounding the efficacy of Chinese COVID-19 vaccines against the Delta variant has had many questioning them, especially after a recent study showed that one of those vaccines, Sinovac Biotech Ltd.’s Coronavac, was less effective than Pfizer Inc. and Biontech SE’s Comirnaty in Chile.
Harbour Biomed Therapeutics Ltd. said its anti-FcRn monoclonal antibody, batoclimab, generated top-line phase II data in generalized myasthenia gravis, and the company expects to move into a phase III study by the end of this year, with final data reported in April 2022.
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.
Fresh from showcasing preliminary evidence for the tolerability and potential benefits of LVGN-6051 at ASCO’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.
Zydus Cadila Ltd. has applied for emergency use authorization in India for its DNA plasmid COVID-19 vaccine, potentially the first shot of its kind to be approved in humans. The filing for the vaccine called ZyCoV-D will be based on a phase III study showing efficacy of 66.6% for symptomatic disease and 100% efficacy for moderate disease.
Medigen Vaccine Biologics Corp. released results from a phase III trial of its enterovirus 71 (EV71) vaccine that showed efficacy of 100% against a virus that causes hand, foot and mouth disease and continues to emerge on a regular basis across Asia.
Jacobio Pharmaceuticals Group Co. Ltd. has received a milestone payment of $20 million from Abbvie Inc. for dosing the first two patients in the U.S. for a global phase I/IIa study of JAB-3312 in combination with pembrolizumab and binimetinib, taking another step forward in the global SHP2 race.
Immvira Group Co. presented positive phase I data for MVR-T3011 as an intratumoral administration at the 2021 American Society of Clinical Oncology meeting, drawing attention to oncolytic viruses developed by Chinese scientists.
New phase III data on Celltrion Inc.'s COVID-19 therapy, regdanvimab, showed it reduced the risk of hospitalization or death related to the disease for high-risk patients to 3.1% vs. 11.1% for placebo by day 28 of the study. The treatment also proved beneficial to participants across all risk categories, reducing their risk of hospitalization or death to 2.4% vs. 8% for placebo at the same time point.
Beigene Ltd. unveiled positive interim results from its Alpine phase III trial comparing its small-molecule BTK inhibitor, Brukinsa (zanubrutinib), to Abbvie Inc.’s Imbruvica (ibrutinib), lending validity to one of the company’s most important development programs.
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