Depemokimab

While chronic obstructive pulmonary disease (COPD) represents the next sizeable target market for AstraZeneca and Amgen's Tezspire (tezepelumab-ekko) — albeit some ways down the road — the monoclonal antibody on Friday recorded a Phase III study success in chronic rhinosinusitis with nasal polyps (CRSwNP), setting up marketing applications.The WAYPOINT trial randomised adults with severe CRSwNP to receive either Tezspire or placebo via subcutaneous injection over a 52-week treatment period. The study's co-primary endpoints were change from baseline in total nasal polyp size, measured by the endoscopic total Nasal Polyp Score, and change from baseline in bi-weekly mean nasal congestion, measured by the participant-reported Nasal Congestion Score evaluated as part of the daily Nasal Polyposis Symptom Diary.Top-line results showed that Tezspire demonstrated a statistically significant and clinically meaningful reduction in the size of nasal polyps and reduced nasal congestion compared to placebo. "We are excited by the positive results," remarked Sharon Barr, AstraZeneca's EVP of biopharmaceuticals R&D, which "reinforce that [Tezspire's] first-in-class mode of action, targeting TSLP at the top of the inflammatory cascade, effectively addresses the multiple drivers of epithelial-driven inflammatory diseases."The therapy is currently approved in the US and the EU for the add-on maintenance treatment of patients aged 12 years and older with severe asthma. Meanwhile, Phase III studies are also under way in eosinophilic esophagitis and being planned for COPD.Last month, GSK reported that its own monoclonal antibody depemokimab — an ultra-long-acting IL-5-inhibitor — succeeded in a pair of Phase III trials in adults with CRSwNP. The company hopes that the extended half-life of the therapy, also known as GSK3511294, may enable biannual dosing to minimise clinic visits and decrease the risk of inflammation recurrence.

Today, a brief rundown of news from AstraZeneca, Amgen and Jazz Pharmaceuticals, as well as updates from Geron, Gilead Sciences and Avid Bioservices that you may have missed.AstraZeneca and Amgens drug Tezspire reduced nasal congestion and the size of nasal polyps versus placebo in a Phase 3 trial involving people with a form of chronic rhinosinusitis, the companies said Friday. The results, which AstraZeneca and Amgen plan to present at an upcoming medical meeting, could help the two partners expand approval of Tezspire, which is currently cleared for asthma in the U.S. and five dozen other countries. Tezspire could also compete in the future with depemokimab, a drug from GSK that recently succeeded in two Phase 3 studies of people with the same condition. Ned PagliaruloJazz Pharmaceuticals plans to, in the first half of next year, start an early-stage study evaluating an experimental treatment for narcolepsy. Researchers recently tested the drug, called JZP441, in a different Phase 1 clinical trial, but Jazz paused the experiment due to reports of visual disturbances and cardiovascular effects. The drug is designed to target “orexins,“ a class of proteins that regulate important brain activity like wakefulness, arousal, hunger and even mood. On an earnings call Wednesday, Jazz's head of research and development, Robert Iannone, told investors that the new study will not only help the company decide whether to advance JZP441, but also “inform our backup programs. Jacob BellGeron has secured $250 million in funding, and potentially as much as $375 million overall, through agreements with Royalty Pharma and funds managed by Pharmakon Advisors. In the first deal, Geron has sold tiered royalty rights on U.S. net sales of Rytelo, its newly approved drug for anemia in people with myelofibrosis, in exchange for $125 million. The company also secured a 5-year senior secured term loan of up to $250 million from the Pharmakon-associated funds, half of which it has already drawn. Some of the funds have been used to repay loans Geron owed to Hercules Capital and Silicon Valley Bank. The rest will help Geron launch Rytelo and complete further testing of the drug. Ned PagliaruloVenture firm Aditum Bio and China-based Leads Biolabs have formed a new company to develop a tri-specific T cell engager for autoimmune diseases. The new company, dubbed Oblenio Bio, will launch with an exclusive option to develop the drug globally, in exchange for paying Leads $35 million in upfront and near-term fees. Leads will also take an equity stake in Oblenio, the 13th company spun out by Aditum. Ned PagliaruloGilead Sciences will no longer develop its antibody-drug conjugate Trodelvy in second-line non-small cell lung cancer, CEO Daniel ODay told investors Wednesday on an earnings call. The decision followed discussions with regulators after negative results from a lung cancer study earlier this year. As a result, Gilead will take a $1.8 billion write down in the value it ascribes to its in-process R&D. The company continues to develop Trodelvy, which is currently approved for certain kinds of breast tumors, in first-line lung cancer. Ned PagliaruloContract drugmaker Avid Bioservices will be taken private by GHO Capital Partners and Ampersand Capital Partners in a deal worth roughly $1.1 billion. The two investors will pay $12.50 per Avid share, a nearly 14% premium on the stocks closing price Wednesday. The deal comes the same week Ampersand paid $70 million in cash to buy a Nektar Therapeutics drug factory, and follows a pattern of contract development and manufacturing organizations being taken private in recent years. Ned Pagliarulo '