Aiolos Bio’s Post

GSK invests 1.4B to complete acquisition of 𝐈𝐦𝐦𝐮𝐧𝐞 Company Aiolos Bio, acquiring its 𝐚𝐬𝐭𝐡𝐦𝐚 𝐏𝐡𝐚𝐬𝐞 𝐈𝐈 asset GSK plc (LSE/NYSE: GSK) today announced that it has completed the acquisition of Aiolos Bio (Aiolos), a clinical-stage biopharmaceutical company focused on addressing the unmet treatment needs of patients with respiratory and inflammatory conditions. As previously announced,1 the acquisition of Aiolos includes AIO-001, a potentially best-in-class, long-acting anti-thymic stromal lymphopoietin (TSLP) monoclonal antibody ready to enter phase II clinical development for the treatment of adult patients with asthma. AIO-001 could expand GSK’s respiratory biologics portfolio to potentially reach the 40% of severe asthma patients with low T2 inflammation (a type of overactive immune response associated with asthma).2 AIO-001 has the potential to be administered every six months due to its high potency and long half-life, which could redefine the standard-of-care.

AstraZeneca is gearing up to challenge Pfizer in Japan with its heart disease drug, acoramidis, showing promise in phase 3 trials. This development signals a potential shift in the treatment landscape for transthyretin amyloid cardiomyopathy (ATTR-CM), a market currently dominated by Pfizer’s tafamidis. Quick Takes - 🔷 Strategic Move - AstraZeneca's positive trial results in Japan position it for regulatory approval, directly targeting Pfizer's market share. 🔷 Market Opportunity - With tafamidis' modest growth in Japan, AstraZeneca eyes a prime opportunity to introduce acoramidis as a new treatment option. 🔷 Anticipated Competition - AstraZeneca's potential entry could intensify competition, especially if it capitalizes on Pfizer's efforts to increase diagnosis rates in Japan. What’s Next? - The pharmaceutical industry is keenly watching as AstraZeneca plans to unveil more data. The question remains: How will AstraZeneca’s entry reshape Japan's heart disease treatment arena? Considerations for Industry Observers - 🔷 Will AstraZeneca manage to carve out a significant niche in Japan's ATTR-CM market? 🔷 How will Pfizer respond to this emerging challenge? #HealthcareStrategy #AstraZeneca #Pfizer #JapanHealthcare

GSK to Buy #Respiratory Drug Developer Aiolos Bio GSK has agreed to acquire #biotech Aiolos Bio for a $1 billion upfront payment and up to $400 million for the achievement of certain milestones. Founded just last year, Aiolos is a San Francisco, USA and London, UK-based #biopharmaceutical company that develops treatments for respiratory diseases. Aiolos has an experimental drug, AIO-001, ready to enter Phase 2 tests for adults with #asthma, although the monoclonal #antibody has potential in other diseases related to inflammation such as chronic rhinosinusitis and nasal polyps, GSK said. AIO-001 was exclusively licensed to Aiolos outside of China by Jiangsu Hengrui Pharmaceuticals Co., Ltd. GSK’s chief scientific officer, Tony Wood, said: “We have a proud heritage and deep development expertise in respiratory medicines, especially addressing diseases driven by IL-5 with high levels of eosinophils or high T2 inflammation. Adding AIO-001, a potentially best-in-class medicine targeting the TSLP pathway, could expand the reach of our current respiratory biologics portfolio, including to the 40% of severe asthma patients with low T2 inflammation where treatment options are still needed.” Read more on #CMI online: https://lnkd.in/esBgdb49

𝐕𝐞𝐫𝐭𝐞𝐱 𝐏𝐡𝐚𝐫𝐦𝐚𝐜𝐞𝐮𝐭𝐢𝐜𝐚𝐥𝐬 𝐀𝐧𝐧𝐨𝐮𝐧𝐜𝐞𝐬 𝐅𝐃𝐀 𝐀𝐜𝐜𝐞𝐩𝐭𝐚𝐧𝐜𝐞 𝐨𝐟 𝐍𝐃𝐀 𝐟𝐨𝐫 𝐕𝐚𝐧𝐳𝐚 𝐓𝐫𝐢𝐩𝐥𝐞 𝐂𝐨𝐦𝐛𝐢𝐧𝐚𝐭𝐢𝐨𝐧 𝐓𝐡𝐞𝐫𝐚𝐩𝐲 𝐟𝐨𝐫 𝐂𝐲𝐬𝐭𝐢𝐜 𝐅𝐢𝐛𝐫𝐨𝐬𝐢𝐬 Vertex Pharmaceuticals (Nasdaq: VRTX) Vertex Pharmaceuticals announced that the FDA has accepted its New Drug Application (NDA) for the once-daily vanzacaftor/tezacaftor/deutivacaftor triple combination therapy (vanza triple) for cystic fibrosis (CF) patients aged 6 and older with at least one F508del mutation or another responsive mutation. Utilizing a priority review voucher, the Prescription Drug User Fee Act (PDUFA) target action date is January 2, 2025. “The FDA acceptance of our vanza triple application represents an important milestone in CFTR modulator development,” said Nia Tatsis, Ph.D.Nia Tatsis, Executive Vice President at Vertex. “Vanzacaftor raises the bar set by TRIKAFTA® and offers more people with CF the chance to achieve sweat chloride levels below the diagnostic threshold for CF.” The European Medicines Agency (EMA) has also validated Vertex's Marketing Authorization Application (MAA) for patients aged 6 and older. Submissions have been made in Canada, Australia, Switzerland, and the U.K. CF is a rare, life-shortening genetic disease affecting over 92,000 people globally. Vertex CF medicines currently treat over 65,000 people with CF across 60 countries, representing two-thirds of those eligible for CFTR modulator therapy. Diagnosis of CF is confirmed by testing sweat chloride (SwCl), which measures CFTR protein dysfunction. Restoring CFTR function leads to lower SwCl levels, associated with better outcomes and improved survival. #VertexPharmaceuticals #CysticFibrosis #VanzaTriple #CFTRModulators #FDA #ClinicalTrials #Biotechnology #Healthcare #Innovation #CFResearch #Pharma

𝐄𝐱𝐜𝐢𝐭𝐢𝐧𝐠 𝐧𝐞𝐰𝐬 𝐢𝐧 𝐜𝐚𝐫𝐝𝐢𝐨𝐯𝐚𝐬𝐜𝐮𝐥𝐚𝐫 𝐜𝐚𝐫𝐞: Bayer has secured exclusive marketing rights for acoramidis in Europe from Eidos Therapeutics and BridgeBio. The drug looks to be a significant step towards addressing ATTR CM, a fatal cardiovascular disease. Backed by successful Phase III trials, acoramidis demonstrates promise in improving patient outcomes, with significant reductions in hospitalization and enhanced quality of life. Bayer's commitment to transforming cardiovascular treatment underscores their eagerness to make acoramidis accessible to patients as soon as possible, offering hope where it's needed most. The partnership between Bayer and BridgeBio, the developer of acoramidis, is poised to drive impactful change in the treatment landscape. With Bayer's established European infrastructure and BridgeBio's expertise in therapeutic development, the collaboration aims to expedite the availability of acoramidis to patients in need. This milestone agreement not only highlights the potential of acoramidis but also signals a joint commitment to advancing cardiovascular health worldwide. Follow Warman O'Brien for all the latest updates in the life sciences industry! #CardiovascularCare #MedicalInnovation #Bayer #BridgeBio #goodnews #pharmaceutical #biotech

Our COO, Mayukh Das, put on an exciting workshop last week in Boston at the 6th Bacteriophage Therapy summit, where he discussed the major challenges when developing phage products to improve clinical outcomes. In this workshop, he surveyed the audience to gain understanding on how phage developers are building phage therapies and gleaned these insights: 1. For improving clinical outcomes, what are the Top 5 aspects to consider for developing a phage drug product? - PK/PD - Broad host spectrum - Low endotoxin - CMC / Manufacturing - Drug/Disease association 2. What are the Top 5 challenges throughout the entire drug development process for phage therapy? - Stability of phages - Broad efficacy - Finding right phage - Translation from in vitro/vivo to clinic - Scale up of production 3. What do you think are Top 5 limitations to design a clinical trial plan for phage therapy? - Broad spectrum limitations of phages - Finding stable patient population - Dosing regimen - Regulation guidance and constraints - Funding opportunities and mechanisms Interestingly, our findings suggested there is a clear split between focusing on pre-clinical development and clinical trial focus. In fact, over 60% of responses were most concerned with drug discovery and pre-clinical development of phages with the remaining responses focusing on clinical development. We were encouraged by these results as we also believe in building repeatable, rigorous screening and validation models, such as our technology platform, which are critical for finding the right phages with adapted anti-bacterial capabilities, that match every step of bacterial infection. We also got to hear from our phage friends about the great work they are doing and the exciting outcomes they are seeing from their clinical trials. We look forward to the next conference and to see phage progressed further into the clinical settings! #phage #bacteriophage #phagetherapy #Boston #innovation #AMR

In 2023, a new Roivant Sciences subsidiary licensed a clinical-stage drug from a big pharma company and then proceeded to say almost nothing about it for more than a year except for a brief mention in a regulatory filing. Roivant has plenty to say now following the presentation of proof-of-concept clinical data this week during the European Respiratory Society Congress in Austria. The drug, #mosliciguat, is from Bayer. The inhalable therapy is in development for #pulmonaryhypertension associated with interstitial lung disease. PH-ILD is a rare #lungdisease with only one FDA-approved therapy, the blockbuster United Therapeutics Corporation drug #Tyvaso. Roivant executives say mosliciguat’s different mechanism of action could offer advantages in safety and efficacy. It certainly offers a dosing edge — a once daily puff versus the nine to 12 puffs four times daily Tyvaso requires. Roivant pegs the market opportunity in the U.S. and Europe at $6 billion. Mosliciguat is now on track to begin a Phase 2 clinical trial. https://lnkd.in/eE8pNRtA $ROIV $UTHR #biotechnology #pharmaceuticals

Submit Global Regulatory Status Of Atezolizumab For IV, SC Route: CDSCO Panel Tells Roche Products India In response to the proposal presented by the drug major Roche Products India for granting permission to import and market Atezolizumab injection (1875mg/15ml vial) (Tecentriq) by new route of administration i.e., subcutaneous route, the Subject Expert Committee (SEC) functional under the Central Drugs Standard Control Organization (CDSCO) has opined the firm to submit the global regulatory status of the drug Atezolizumab for IV and SC route of administration along with indication. This came after the proposal of the firm has been re-deliberated for the grant of permission to import and market Atezolizumab injection (1875mg/15ml vial) (Tecentriq) by new route of administration i.e., subcutaneous route for indications of Atezolizumab injection approved for Intravenous (IV) route for sale or for distribution in India with local Phase III clinical trial waiver under unmet need in India and commitment to conduct Phase IV study. #rocheproductsindia #RocheProduct(India)PvtLtd #cdsco #atezolizumab #tecentriq #tecentriqSC

Intranasal Drug and Vaccine Delivery Market Insights 2030 The global intranasal drug and vaccine delivery market is anticipated to be worth approximately USD 69.8 billion by 2030, with a projected CAGR of over 7.2% from 2022 to 2030, according to Ameco Research. The Intranasal Drug and Vaccine Delivery Market is at the forefront of transformative innovations in healthcare, offering a non-invasive and efficient method for drug and vaccine administration. Intranasal delivery provides a direct pathway to the bloodstream through the nasal mucosa, bypassing the digestive system and offering advantages in terms of rapid absorption and patient compliance. In this article, we will explore the current market trends, drivers, restraints, opportunities, regional insights, key competitors, and the promising future growth potential of the Intranasal Drug and Vaccine Delivery Market. Request for a sample of this premium research report @ https://lnkd.in/dcD67miZ

[Celltrion's Zymfentra makes US debut] Korean biopharmaceuticals firm Celltrion Inc announced Monday that its new autoimmune disease treatment Zymfentra has been launched in the US market. Zymfentra is a subcutaneous injection formulation of Celltrion's infliximab Remsima. In October last year, the US Food and Drug Administration approved Zymfentra (infliximab-dyyb) for the maintenance treatment of adults with moderately to severely active ulcerative colitis and Crohn’s disease. "Infliximab is a well-established treatment for people living with ulcerative colitis or Crohn's disease," said Thomas Nusbickel, chief commercial officer at Celltrion USA. "The novel subcutaneous administration represents an important advancement in patient care that can offer a convenient treatment option, allowing patients in the US to have greater flexibility in managing their disease." Celltrion said the wholesale acquisition cost of two injections of Zymfentra, which a patient needs in four weeks, has been set at $6,181. “The company has been able to set an optimal price for the drug considering the prices of its competing products,” Celltrion said. Tap below to read full story. #Celltrion #Zymfentra #drug #biotech #bio #patient #US #pharmaceutics https://lnkd.in/gxQnMXg5