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.
Lilly taps Verge Genomics AI-driven discovery platform in new multiyear ALS targets deal
In search of new therapies for amyotrophic lateral sclerosis (ALS), Eli Lilly and Co. has agreed to pay Verge Genomics $25 million in up-front, equity, and potential near-term payments, plus as much as $694 million in milestones, to discover and validate up to four new targets for treating the disease over the course of a three-year collaboration. Verge retained rights to its internal lead ALS program, poised to enter the clinic next year.
Biogen’s new label for Aduhelm limits use
Following battles over its price and accelerated approval, Biogen Inc.’s Aduhelm (aducanumab) now has newly approved prescribing information from the FDA that limits the patient population and sales along with it. The updated Indications and usage now reads that the anti-amyloid beta monoclonal antibody should be initiated in patients with mild cognitive impairment due to Alzheimer’s disease or mild Alzheimer’s dementia. That’s the patient population in which treatment was initiated in clinical trials. The company said the new wording “clarifies the indication.” The original FDA-approved language cleared the drug for much broader use in Alzheimer’s. Aduhelm comes with a $56,000 per year list price.
Oncopeptides’ stock drops as FDA places partial hold on melflufen after trial data snafu
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).
Boehringer, Lilly data with Jardiance highlight CV efforts by varied players
Upbeat data disclosed recently 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. Development activity in heart failure (HF), in particular, continues briskly. Among the pipeline prospects is istaroxime, a first-in-class, dual-action agent in the works for acute decompensated HF by Windtree Therapeutics Inc.
Aicuris heads for phase III with HSV drug pritelivir
Aicuris Anti-Infective Cures AG is beginning the pivotal phase III part of its trial of pritelivir for herpes simplex virus (HSV) infection after an encouraging mid-stage readout. Based in Wuppertal, Germany, Aicuris is best known for its licensing tie-up with Merck & Co. Inc., which led to big U.S. pharma gaining approval in 2017 for Prevymis (letermovir) for prophylaxis of cytomegalovirus infection after stem cell transplant. Aicuris is following this up with pritelivir, a helicase-primase inhibitor, which has just produced a readout from the first part of its phase II/III PRIOH-1 trial in patients whose infection is resistant to the commonly used first-line drug acyclovir.
Keymed raises $378M in Hong Kong debut
Keymed Biosciences Inc. debuted on the Hong Kong Stock Exchange on July 8, raising HK$2.94 billion (US$378.48 million) in the process. Chengdu, China-based Keymed develops therapies to treat cancer and autoimmune diseases. A key product that stands to benefit from the funds is CM-310, an IL-4Rα monoclonal antibody designed to treat moderate-to-severe atopic dermatitis, moderate-to-severe chronic rhinosinusitis with nasal polyposis and moderate-to-severe eosinophilic asthma.
Also in the news
Aicuris, Akston, Amgen, ASC, Astrazeneca, Atyr, Beigene, Bioasis, Biogen, Bridgebio, Can-Fite, Codexis, Corat, Daiichi Sankyo, Dermapharm, Eisbach, Ensysce, Enveric, Evaxion, Exscientia, Ideaya, Immutep, Ischemix, Janssen, Medolife, NMD, Oncopeptides, Pluristem, Prilenia, Reset, Sellas, Sunshine, Theolytics, Trevena, Triact, Valneva, Vor