Once-daily insulin treatment is getting a challenge from Novo Nordisk A/S’s once-weekly option. The U.S. FDA’s Endocrinologic and Metabolic Drugs Advisory Committee meets Friday, May 23, to review the BLA for once-weekly Awiqli (insulin icodec), a human insulin analogue from Novo for adults with type 1 diabetes mellitus.
In a deal worth up to $1.8 billion, Biogen Inc. is buying Human Immunology Biosciences Inc. (Hibio), bolstering its late-stage immune-disease treatment portfolio and diversifying its pipeline. The massive amount comprises $1.15 billion up front and as much as $650 in potential milestone payments. The deal in rare diseases brings Biogen phase III-ready felzartamab, a fully human monoclonal antibody that selectively depletes CD38-positive plasma cells and natural killer cells. Hibio also is developing izastobart, an anti-C5aR1 antibody. Both assets were in-licensed from Morphosys AG in June 2022. Hibio also has mast cell programs in the discovery stage.
Prologue Medicines Inc. has launched to develop therapeutics created from the viral proteome, which are proteins produced across all viruses. It’s a newer twist on harnessing the power of the proteins that regulate biology. The company was founded on the premise of peering beyond the human proteome to see if there were viral proteins that could become therapeutics, Theonie Anastassiadis, Prologue’s founding president, told BioWorld.
The radiopharmaceutical revolution rolls on as Eli Lilly and Co. builds on its prowess in the space with a deal that could bring Aktis Oncology Inc. $1.1 billion. The two plan to develop radiopharmaceuticals targeting cancer. Privately held Aktis also is getting $60 million in cash up front along with an equity investment. The big money would come from preclinical, clinical, regulatory, commercial milestones and tiered royalties. Lilly will select the targets.
With positive phase IIa data for ENV-101 in idiopathic pulmonary fibrosis (IPF) in hand, showing some lung damage was reversed, Endeavor Biomedicines Inc. said it’s ready to begin further phase II studies in the indication.
The U.S. FDA granted accelerated approval to Amgen Inc.’s Imdelltra (tarlatamab) for treating adults with extensive-stage small-cell lung cancer with disease progression on or after platinum-based chemotherapy. The approval may well lead the drug to blockbuster status while bolstering the company’s cancer portfolio.
Johnson & Johnson is adding to its dermatology portfolio with the $850 million purchase of privately held Proteologix Inc. The Redwood City, Calif.-based company brings with it two bispecific antibodies into a space dominated by the blockbuster injectable Dupixent (dupilumab). Proteologix has PX-128, which targets IL-13 plus thymic stromal lymphopoietin for treating moderate to severe atopic dermatitis and moderate to severe asthma, and PX-130, which also targets IL-13 plus IL-22, for treating moderate to severe AD. Both are in preclinical development, but Johnson & Johnson said PX-128 is ready for its phase I close-up.
A non-traditional route for financing has been the path to success for Fibrobiologics Inc. In the newest BioWorld Insider podcast, CEO Pete O’Heeron offers insight into the company’s unusual path to a Nasdaq listing in January.
Positive data from Novo Nordisk A/S’s pivotal phase IIIa study of once-weekly and once-monthly doses of its hemophilia treatment, Mim8, are prompting the company to say it will submit the first regulatory approval request toward the end of this year. It could challenge Roche Holding AG’s Hemlibra (emicizumab), a bispecific factor IXa- and factor X-directed antibody for hemophilia A, that was approved in 2017 by the U.S. FDA.
Citing a high rate of patients leaving the study, Merck & Co. Inc. has discontinued the anti-TIGIT antibody vibostolimab and the anti-PD-1 Keytruda (pembrolizumab) portion of it phase III Keyvibe-10 trial as an adjuvant treatment for those with resected high-risk melanoma.
