Shares of Vir Biotechnology Inc. (NASDAQ:VIR) were trading at $12.62, up $2.04, or 19%, after the San Francisco-based firm unveiled preliminary data from its phase II Solstice hepatitis delta virus (HDV) study evaluating the monoclonal antibody tobevibart and elebsiran, a small interfering ribonucleic acid, for the treatment of people living with chronic disease. Treatment with tobevibart alone or in combination with elebsiran was generally well-tolerated, and HDV participants achieved high rates of virologic response at weeks 12 and 24, durable virologic response through 48 weeks, and high rates of alanine aminotransferase normalization, Vir said.

Amgen’s inebilizumab succeeds in phase III IgG4-RD trial

Amgen Inc.’s inebilizumab could become the first therapeutic specifically to treat immunoglobulin G4-related disease (IgG4-RD), a rare, immune-mediated condition that can affect multiple organs, after yielding what Leerink Partners analyst David Risinger called “exceptional” results in the phase III study. The 52-week trial, called Mitigate, demonstrated a statistically significant 87% reduction in the risk of IgG4-RD flare vs. placebo, while also meeting all secondary endpoints and revealing no new safety signals. A B-cell depleting anti-CD19 monoclonal antibody, inebilizumab previously gained approval as Uplizna for use in neuromyelitis optica spectrum disorder. Amgen gained rights to the drug via its $27.8 billion buyout of Horizon Therapeutics plc in 2022.

Adcom a ‘learning experience’ for psychedelic development

The discussion that preceded yesterday’s U.S. FDA advisory committee vote against the approval of Lykos Therapeutics Inc.’s midomafetamine  as a treatment for post-traumatic stress syndrome could shed light on the way forward for other sponsors developing psychedelics for approved medical use. Functional unblinding, expectation bias, abuse potential, inadequate safety data, lack of diversity and allegations of therapist misconduct in the Lykos trials all figured into the Psychopharmacologic Drugs Advisory Committee’s conversation. “We see these problems as a learning experience for other sponsors who follow,” said Brian Abrahams, head of global health care research at RBC Capital Markets. 

Australian VC firm Brandon Capital closes new AU$270M fund 

Life sciences venture capital company, Brandon Capital, announced the first close of its sixth fund for AU$270 million (US$180 million) during the 2024 Biotechnology Innovation Organization International Convention in San Diego. Fund VI will see Brandon Capital continue to seed new Australian and New Zealand life sciences startups, as well as advance its expansion into international markets, particularly in the U.K., Europe, and the U.S. Since its establishment in 2007, Brandon Capital has raised more than AU$1 billion (US$665.2 million) across five funds and completed more than 60 investments in new therapeutic, medical device, and health tech companies.

Blueprint’s work behind drug for fibrodysplasia ossificans progressiva

Fibrodysplasia ossificans progressiva (FOP) is a rare and life-threatening genetic disease caused by gain-of-function mutations in the ALK2 gene. The most common mutation is ALK2 R206H, which leads to increased and dysregulated signaling to the bone morphogenetic protein, where skeletal muscle and connective tissue is replaced by heterotopic bone, a process called heterotopic ossification that results in the immobilization of a joint about every 2 years. In a paper published May 29, 2024, in Science Translational Medicine, Blueprint Medicines Corp. elucidated the discovery of their ALK2 inhibitor BLU-782 for the treatment of FOP.

Also in the news

Aeterna Zentaris, Alphamab, Alveolix, Annexon, Arrivent, Astrazeneca, Be, Biolojic Design, Bridgebio, Capricor, Ceapro, Coherus, Crinetics, Eledon, Epiendo, Equillium, Fusion, Glycomimetics, HMNC Brain Health, Immunitybio, Innate, Ladrx, Lumos, Merck, Neoimmunetech, OS Therapies, Osteal, Pharvaris, Rhythm, Scitech, Spruce, Telix, Valneva, Viking, Vilya, Y-Mabs, Zevra