Invivyd Inc. unveiled positive 180-day exploratory clinical efficacy data from the company’s ongoing Canopy phase III trial with pemivibart, a half-life-extended monoclonal antibody for the pre-exposure prophylaxis of COVID-19. At the same time, though, the U.S. FDA revised the emergency use authorization for the compound, known as Pemgarda, saying the drug may only be deployed when the combined national frequency of variants with substantially reduced susceptibility to Pemgarda is less than or equal to 90%. The agency said numbers on variant susceptibility as well as national variant frequencies led to the switch, made in case the variants in question reach the specified threshold. In the days leading up to the latest data, shares of Waltham, Mass.-based Invivyd (NASDAQ:IVVD) rose by more than 20% to reach a high of $1.34 in after-hours trading on Aug. 26, but were selling after the recent developments at $1.17, down 12 cents.

Microbiotica entering clinic with live bacterial therapeutics

Microbiotica Ltd. is poised to advance two of its microbiome-derived products into the clinic after securing regulatory approval and fresh finance. The first live bacterial therapeutic, MB-097, will be tested in combination with Keytruda (pembrolizumab) in patients with advanced melanoma who have not responded to treatment with immune checkpoint inhibitors. The second product, MB-310, is a once-daily oral therapy for treating the inflammatory bowel disease, ulcerative colitis. Both products were discovered using Microbiotica’s microbiome profiling platform technology.

UCB sells off China mature products to CBC Group for $680M

UCB SA is divesting its mature neurology and allergy business in China, selling those products to CBC Group and Mubadala Investment Co. for $680 million so it can refocus on innovation and partnerships in China. The deal includes UCB’s manufacturing site in Zhuhai in Guangdong province.  Those mature products in UCB’s neurology and allergy portfolio include epilepsy drugs Keppra (levetiracetam) and Vimpat (lacosamide), Parkinson’s disease treatment Neupro (rotigotine), and allergy drugs Zyrtec (cetirizine) and Xyzal (levocetirizine). Combined net sales for these drugs in China for 2023 were €131 million (US$146 million).  

Newco Diakonos raises $11.4M for its dendritic cell vaccine

Diakonos Oncology Corp. raised $11.4 million, nearly triple its initial target, in a seed financing round led by Restem Group Inc., with participation from existing investors. The company is developing DOC-1021 for the treatment of glioblastoma with plans to start a phase II clinical trial for the dendritic cell vaccine in the fourth quarter of 2024.

Stem cells eat dead cells to ensure tissue integrity

Despite being the most undifferentiated cells in an organism, stem cells have multiple jobs. They do not just produce new cells, they also clean the house, keeping tissues free of dead cells. Phagocytosis – eliminating millions of dead cells every day – requires specialized cells such as macrophages, the true professionals, which migrate to engulf waste and dying cells. But they are not the only ones that can perform this task, as scientists at Howard Hughes Medical Institute (HHMI) discovered when they investigated hair follicle stem cells (HFSCs), a tissue in constant regeneration, to clarify how dying cells are detected and cleared in the epithelium and the mesenchyme. “Most tissues in the body have epithelial cells that are able to engulf apoptotic corpses,” senior author Elaine Fuchs, a professor at HHMI, The Rockefeller University, and co-author Katherine Stewart, a postdoc, told BioWorld.

Also in the news

Achieve Life Sciences, Arca, ARS, Beigene, Celltrion, Eyenovia, Invenra, MBX, Memo, Merck, Moderna, Nanoviricides, Notable Labs, Redhill, Regeneron, Rhythm, Sana, Telix, Vericel