Latest news with #monoclonalAntibody
CNN
31 minutes ago
- Health
- CNN
Newly approved therapy could offer another option for protecting infants from RSV, a common infection that can be deadly
The United States could soon have another tool in the fight against respiratory syncytial virus, an illness that's the No. 1 cause of hospitalization in infants. The US Food and Drug Administration has approved a new monoclonal antibody to help prevent infection, according to an announcement late Monday from drugmaker Merck. The therapy, Enflonsia, is designed to be given in a single 105-milligram shot to protect newborns and infants from mild, moderate or severe RSV through all five months of their first virus season, which typically starts in the fall and goes through the next spring. Study materials that Merck submitted to the FDA for its approval showed that the antibody had a similar safety profile as a placebo. The most common adverse reactions from Enflonsia were mild and included injection-site swelling and a rash in a small number of infants. In a mid- to late-stage trial, Enflonsia reduced RSV-associated hospitalizations in infants more than 84% compared with a placebo. RSV can sometimes turn into serious lower respiratory infections like pneumonia, but the shot also reduced lower respiratory infections that needed medical attention by more than 60% compared with a placebo. 'Enflonsia provides an important new preventive option to help protect healthy and at-risk infants born during or entering their first RSV season,' Dr. Dean Y. Li, president of Merck Research Laboratories, said in a news release. 'We are committed to ensuring availability of Enflonsia in the US before the start of the upcoming RSV season to help reduce the significant burden of this widespread seasonal infection on families and health care systems.' Merck says it hopes Enflonsia will be available before the start of the 2025-26 respiratory virus season. First, it needs to be recommended by the US Centers for Disease Control and Prevention, and that means going in front of the agency's Advisory Committee on Immunization Practices. It's on the agenda for the panel's meeting this month, but US Health and Human Services Secretary Robert F. Kennedy removed all the members of that committee Monday. He says he will appoint new ones, but it's unclear how long that process will take. Doctors say another tool to prevent RSV cannot come soon enough. RSV is ubiquitous, one of the most common causes of childhood illness. Most kids will catch this highly contagious respiratory virus at some point before they turn 2, according to the CDC. For many healthy adults and older kids, RSV causes a mild illness like a cold. Typically, symptoms can be managed at home, and they often go away on their own. But for infants and the elderly, it can be a different story. Very young children's immune systems are just starting to learn how to fight infections, and infants have tiny airways. RSV inflames those airways, making it difficult to breathe, and can turn into a serious lower respiratory illness like bronchiolitis or pneumonia. Some of these RSV infections can be deadly. Two to three percent of infants under 6 months are hospitalized with RSV in the US every year, according to the CDC. Among children younger than 5, about 58,000 to 80,000 are hospitalized due to RSV. There's no specific medicine to treat RSV. Doctors can give an infant supportive care and oxygen, and then they essentially wait until their oxygen levels get back to normal, said Dr. Amy Edwards, director of pediatric infection control at UH Rainbow Babies and Children's Hospital in Cleveland. 'I hate RSV,' said Edwards, who was not connected with the Merck trial. 'Just to watch them struggle to breathe, and then they get scared, and then they cry, which of course makes the breathing worse, and their little lips turn blue. It's just so hard to watch.' Enflonsia joins a handful of other tools recently made available to protect babies from, although the FDA put RSV vaccine trials involving infants and young children ages 2 to 5 on hold last year after some developed severe illness. To prevent RSV in infants, the CDC currently recommends an RSV antibody made by Sanofi and AstraZeneca, called Beyfortus, which was approved in 2023. It was in short supply during that year's RSV season, although Edwards said supply started to catch up with demand in her health care system last season, and the company pledged to produce more. The other option to protect an infant is a vaccine that a person can get during pregnancy. Together, Beyfortus and the vaccine have made a difference. A CDC study published in March found that RSV-associated hospitalization rates among infants up to 7 months during 2024-25 season were lower than in seasons when those therapies weren't available. Edwards just hopes people will get protection for their infants. 'Every RSV season fills us to the gills,' she said. 'This should theoretically empty us out, if we have good uptake.'
Globe and Mail
5 hours ago
- Health
- Globe and Mail
Merck Secures FDA Nod for New RSV Antibody Enflonsia in Infants
Merck MRK announced FDA approval for its prophylactic long-acting monoclonal antibody, clesrovimab, for the prevention of RSV in newborns and infants born during or entering their first RSV season. The drug will be marketed under the brand name Enflonsia. The FDA's decision came a day ahead of the previously announced target date of June 10, 2025. The approval is based on data from the pivotal phase IIb/III CLEVER study, which showed that treatment with a single dose of Enflonsia significantly reduced the incidence of RSV disease and hospitalization in healthy preterm and full-term infants. Merck plans to launch Enflonsia in the United States ahead of the upcoming 2025-26 RSV season and expects ordering for the shots to start next month. Per a Reuters article, Merck will price the antibody at $556 per dose. Merck's Stock Performance Year to date, Merck's shares have lost 20% compared with the industry 's 1% decline. Other RSV Antibodies/Vaccines Available in the Market Once commercially launched, Merck's Enflonsia will face stiff competition from AstraZeneca AZN / Sanofi 's SNY RSV antibody Beyfortus, which was also approved for a similar indication in 2023. This AstraZeneca-Sanofi antibody achieved blockbuster status in its first full-year sales in 2024. Coincidentally, on the same day Enflonsia received approval, Sanofi revealed an aggressive effort to increase the supply of the AstraZeneca-partnered Beyfortus, including a plan to start shipping the antibody early in the third quarter of 2025. While there are multiple vaccines approved for preventing RSV in the United States, the only one approved for immunizing infants is Pfizer 's PFE Abrysvo. Unlike Beyfortus and Enflonsia, which can be administered directly, the Pfizer vaccine protects infants through maternal immunization. Most of the marketed RSV vaccines, including Pfizer's, are approved for use in older adults aged 60 years and above. MRK's Cholesterol Drug Meets Goal in Two Late-Stage Studies In a separate press release, Merck announced topline data from two phase III studies, CORALreef HeFH and CORALreef AddOn, which evaluated their investigational oral PCSK9 inhibitor, enlicitide decanoate, in adults with hyperlipidemia who had been previously treated with a statin. Both studies met their primary and key secondary endpoints, showing statistically significant and clinically meaningful greater reductions in low-density lipoprotein cholesterol (LDL-C) after treatment with enlicitide. While the CORALreef HeFH evaluated the drug against a placebo, the CORALreef AddOn assessed the drug against other oral non-statin therapies. MRK's Zacks Rank Merck currently carries a Zacks Rank #3 (Hold). You can see the complete list of today's Zacks #1 Rank (Strong Buy) stocks here. Only $1 to See All Zacks' Buys and Sells We're not kidding. Several years ago, we shocked our members by offering them 30-day access to all our picks for the total sum of only $1. No obligation to spend another cent. Thousands have taken advantage of this opportunity. Thousands did not - they thought there must be a catch. Yes, we do have a reason. We want you to get acquainted with our portfolio services like Surprise Trader, Stocks Under $10, Technology Innovators, and more, that closed 256 positions with double- and triple-digit gains in 2024 alone. See Stocks Now >> Want the latest recommendations from Zacks Investment Research? Today, you can download 7 Best Stocks for the Next 30 Days. Click to get this free report Sanofi (SNY): Free Stock Analysis Report AstraZeneca PLC (AZN): Free Stock Analysis Report Pfizer Inc. (PFE): Free Stock Analysis Report Merck & Co., Inc. (MRK): Free Stock Analysis Report This article originally published on Zacks Investment Research (
Yahoo
29-05-2025
- Business
- Yahoo
H.C. Wainwright Maintains Buy Rating on Oruka (ORKA) After the Early Start of OKRA-002 Trial
On May 27, analyst Mitchell Kapoor from H.C. Wainwright reiterated a Buy rating on Oruka Therapeutics, Inc. (NASDAQ:ORKA) while keeping the price target at $45. The reiterated bullish sentiment comes after the company initiated the dosing of its OKRA-002 trial ahead of the schedule. A clinical researcher in a lab examining a new biopharmaceutical product. Kapoor noted the early start of dosing for OKRA-002 to be a significant milestone for the company. ORKA-002 is a novel monoclonal antibody targeting IL-17A and IL-17F for psoriasis; early start indicates the company's attention to clinical development timelines. Moreover, Kapoor believes that ORKA-001 and ORKA-002 are well-positioned to compete with existing treatments such as Bimzelx. Therefore, the analyst highlights the current valuation of Oruka Therapeutics, Inc. (NASDAQ:ORKA) does not reflect the potential of its lead products. Oruka Therapeutics, Inc. (NASDAQ:ORKA) is a clinical-stage biopharmaceutical company focused on developing novel monoclonal antibody therapeutics primarily for psoriasis and other inflammatory and immunology conditions. ORKA-001 and ORKA-002 are the company's lead products. While we acknowledge the potential of ORKA as an investment, our conviction lies in the belief that some AI stocks hold greater promise for delivering higher returns and have limited downside risk. If you are looking for an AI stock that is more promising than ORKA and that has 100x upside potential, check out our report about the . READ NEXT: and . Disclosure: None.
Medscape
26-05-2025
- Health
- Medscape
Nirsevimab Cuts RSV Hospitalizations in Spanish Study
The introduction of universal passive immunisation with nirsevimab, a long-acting monoclonal antibody, led to significant reductions in hospitalizations and paediatric intensive care admissions for respiratory syncytial virus–associated lower respiratory tract infections (RSV-LRTIs), particularly benefiting infants younger than 6 months. METHODOLOGY: Researchers carried out a prospective observational study at a tertiary hospital in Spain to examine if universally administering nirsevimab could reduce hospitalizations and paediatric intensive care admissions due to RSV-LRTIs in children younger than 5 years. They analysed 311 patients (median age, 4.9 months; 57.5% boys), comparing hospitalization rates during the October 2023-March 2024 RSV season — when nirsevimab was administered — with those during two pre-pandemic seasons (2018-2019 and 2019-2020) and one post-pandemic season (2022-2023). Nirsevimab immunoprophylaxis was given to all newborns with a gestational age of at least 35 weeks, to infants younger than 6 months, and to high-risk children younger than 2 years. TAKEAWAY: RSV-LRTI hospitalizations in infants younger than 6 months declined by 83.3% (95% CI, 70.9-95.8) during the period when nirsevimab was administered compared with those in the pre-pandemic periods and declined by 90.8% (95% CI, 83.6-98.0) compared with those in the post-pandemic period. Additionally, paediatric intensive care admissions declined by 73.3% during the period when nirsevimab was administered compared with those in the pre-pandemic periods and by 87.9% compared with those in the post-pandemic period. The median age of hospitalized patients significantly increased during the nirsevimab period, rising to 15.6 months, whereas it was 4 months and 3.4 months in the pre- and post-pandemic periods, respectively ( P < .001). < .001). Additionally, hospital stays were shorter during the nirsevimab period, with a median of 4 days, whereas they lasted a median of 6 days and 5 days in the pre- and post-pandemic periods, respectively ( P = .003). IN PRACTICE: "These findings are encouraging, and it is anticipated that in the coming years, nirsevimab prophylaxis will mitigate the significant burden on healthcare services during the winter season," the authors wrote. SOURCE: The study was led by Lorena Bermúdez-Barrezueta, Faculty of Medicine, Valladolid University, Valladolid, Spain. It was published online on May 16, 2025, in the European Journal of Pediatrics . LIMITATIONS: This was a single-centre study with a limited sample size. DISCLOSURES: The study was supported by FEDER European Funds and the Junta de Castilla y León under the Research and Innovation Strategy for Smart Specialization and partially funded by the Ernesto Sanchez Villares Foundation.
National Post
09-05-2025
- Health
- National Post
AbCellera Presents Positive Preclinical Data on ABCL575 at the 2025 SID Annual Meeting
Article content ABCL575 is a novel, half-life extended anti-OX40L monoclonal antibody that is being developed for the treatment of moderate-to-severe atopic dermatitis (AD) In preclinical studies, ABCL575 shows potent inhibition of inflammatory pathways, favorable in vivo pharmacokinetics (PK), and potential for less frequent dosing compared to a clinical benchmark Article content Article content VANCOUVER, British Columbia — AbCellera (Nasdaq: ABCL) today announced preclinical data on ABCL575, which will be presented as a poster at the Society for Investigative Dermatology (SID) Annual Meeting at the Hilton Bayfront in San Diego, California. Article content AbCellera's presentation, which is available for viewing here, describes key properties of ABCL575, including: Article content Potent functional activity that is equivalent to the most advanced clinical benchmark, with inhibition of OX40L signalling and T-cell activation in vitro and significant reduction of Th2 cytokines in vivo. Modified Fc domain that supports Fc-silencing and half-life extension, with a predicted human half-life of more than 60 days from preclinical in vivo PK data. Positive nonclinical safety profile and favorable stability when formulated at high concentration. Article content 'We are encouraged by our preclinical data, which show high potency and a predicted extended half-life, demonstrating potential for ABCL575 to be a best-in-class treatment for people with atopic dermatitis,' said Geoff Nichol, MB ChB, SVP, Development at AbCellera. 'We look forward to advancing this molecule into the clinic and are on track to do so this year.' Article content Title: Preclinical development of ABCL575, a half-life extended anti-OX40L monoclonal antibody for the treatment of autoimmune conditions Abstract Number: 0980 Session: Translational Studies: Preclinical Date and Time: Friday, May 9, from 4:30 p.m. to 6:00 p.m. PT Location: Indigo Ballroom & Foyer Article content About ABCL575 Article content ABCL575 is a fully human, half-life extended anti-OX40L monoclonal antibody being investigated for the treatment of moderate-to-severe atopic dermatitis (AD), with potential applications to other inflammatory and autoimmune conditions. Antibody-mediated blockade of OX40/OX40L signaling is a clinically validated mechanism to modulate inflammation. Targeting OX40L, an upstream driver of the AD inflammatory cascade, has the potential to enable broader inhibition of inflammatory pathways and more durable responses than currently approved biologics. In preclinical studies, ABCL575 shows potent inhibition of T cell-mediated inflammatory pathways, favorable tolerability, and in vivo half-life that may support less frequent dosing than current clinical-stage molecules. ABCL575 is projected to enter Phase 1 clinical trials in 2025. Article content About AbCellera Biologics Inc. Article content AbCellera (Nasdaq: ABCL) discovers and develops antibody medicines for indications across therapeutic areas, including cancer, metabolic and endocrine conditions, and autoimmune disorders. AbCellera's platform integrates technology, data science, infrastructure, and interdisciplinary teams to solve the most challenging antibody discovery problems. AbCellera is focused on advancing an internal pipeline of first-in-class and best-in-class programs and collaborating on innovative drug development programs with partners. For more information, please visit Article content This press release contains forward-looking statements, including statements made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. The forward-looking statements are based on management's current beliefs and assumptions and on information currently available to management. All statements contained in this release other than statements of historical fact are forward-looking statements, including statements regarding our ability to develop, commercialize, and achieve market acceptance of our current and planned products and services, our research and development efforts, and other matters regarding our business strategies, use of capital, results of operations and financial position, and plans and objectives for future operations. Article content In some cases, you can identify forward-looking statements by the words 'may,' 'will,' 'could,' 'would,' 'should,' 'expect,' 'intend,' 'plan,' 'anticipate,' 'believe,' 'estimate,' 'predict,' 'project,' 'potential,' 'continue,' 'ongoing' or the negative of these terms or other comparable terminology, although not all forward-looking statements contain these words. These statements involve risks, uncertainties, and other factors that may cause actual results, levels of activity, performance, or achievements to be materially different from the information expressed or implied by these forward-looking statements. These risks, uncertainties, and other factors are described under 'Risk Factors,' 'Management's Discussion and Analysis of Financial Condition and Results of Operations,' and elsewhere in the documents we file with the Securities and Exchange Commission from time to time. We caution you that forward-looking statements are based on a combination of facts and factors currently known by us and our projections of the future, about which we cannot be certain. As a result, the forward-looking statements may not prove to be accurate. The forward-looking statements in this press release represent our views as of the date hereof. We undertake no obligation to update any forward-looking statements for any reason, except as required by law. Article content Article content Article content Contacts Article content Article content Article content
