A&O Shearman’s Post

GSK has restructured its deal with CureVac, 𝐩𝐚𝐲𝐢𝐧𝐠 $𝟒𝟐𝟗 𝐦𝐢𝐥𝐥𝐢𝐨𝐧 𝐮𝐩𝐟𝐫𝐨𝐧𝐭 𝐭𝐨 𝐠𝐚𝐢𝐧 𝐟𝐮𝐥𝐥 𝐜𝐨𝐧𝐭𝐫𝐨𝐥 𝐨𝐟 𝐭𝐡𝐞𝐢𝐫 𝐜𝐨𝐥𝐥𝐚𝐛𝐨𝐫𝐚𝐭𝐢𝐯𝐞 𝐦𝐑𝐍𝐀 𝐢𝐧𝐟𝐥𝐮𝐞𝐧𝐳𝐚 𝐚𝐧𝐝 𝐂𝐨𝐯𝐢𝐝 𝐯𝐚𝐜𝐜𝐢𝐧𝐞 𝐜𝐚𝐧𝐝𝐢𝐝𝐚𝐭𝐞𝐬. This strategic move allows GSK to take over all development and commercialization responsibilities for these vaccines, previously shared with CureVac. In tandem with this deal, 𝐂𝐮𝐫𝐞𝐕𝐚𝐜 𝐢𝐬 𝐥𝐚𝐲𝐢𝐧𝐠 𝐨𝐟𝐟 𝟑𝟎% 𝐨𝐟 𝐢𝐭𝐬 𝐰𝐨𝐫𝐤𝐟𝐨𝐫𝐜𝐞 as it shifts focus back to early-stage technology innovation and preclinical vaccine programs. This realignment is part of CureVac’s effort to optimize its operations and financial stability, extending its runway to 2028. Despite these changes, CureVac will continue to pursue its oncology pipeline, aiming to bring additional vaccines into human trials by 2025. https://lnkd.in/d34hzerx #Healthcare #Vaccines #Biotech #Pharma #mRNA

Sanofi and Novavax Announce Co-Exclusive Licensing Agreement to Co-Commercialize COVID-19 Vaccine and Develop Novel Flu-COVID-19 Combination Vaccines - Agreement provides patients with broader access to a protein-based non-mRNA adjuvanted COVID-19 vaccine through combined commercial strength, from 2025 onwards - Accelerates potential for development of a novel flu-COVID-19 combination product based on authorized vaccines with demonstrated efficacy and tolerability, potentially offering patients enhanced convenience and protection Read the Sanofi Press Release: https://lnkd.in/ebJxEZtW Read the Novavax Press Release: https://lnkd.in/dTW5zzas

𝐆𝐒𝐊 𝐚𝐧𝐝 𝐂𝐮𝐫𝐞𝐕𝐚𝐜 𝐑𝐞𝐬𝐭𝐫𝐮𝐜𝐭𝐮𝐫𝐞 𝐂𝐨𝐥𝐥𝐚𝐛𝐨𝐫𝐚𝐭𝐢𝐨𝐧 𝐢𝐧𝐭𝐨 𝐍𝐞𝐰 𝐋𝐢𝐜𝐞𝐧𝐬𝐢𝐧𝐠 𝐀𝐠𝐫𝐞𝐞𝐦𝐞𝐧𝐭 GSK plc (LSE/NYSE: GSK)GSK and CureVac N.V. (Nasdaq: CVAC) CureVac announced a new licensing agreement to prioritize their respective mRNA development activities. This restructure allows GSK to take full control of developing and manufacturing mRNA vaccine candidates for seasonal influenza, COVID-19, and avian influenza, which are currently in clinical development phases. Under the new agreement, GSK will commercialize these vaccines globally, while CureVac receives an upfront payment of €400 million and up to €1.05 billion in milestones and royalties. CureVac retains rights to undisclosed infectious disease targets and can develop mRNA vaccines in other indications independently. Tony Wood, Chief Scientific Officer at GSK, stated, “We are excited about our flu/COVID-19 programs and the opportunity to develop best-in-class mRNA vaccines.” Alexander Zehnder Alexander Zehnder, MD, MBA, CEO of CureVac, added, “This new agreement strengthens our financial position and enables us to focus on building a robust R&D pipeline.” Completion of the agreement is subject to antitrust and regulatory approvals and customary closing conditions. #GSK #CureVac #mRNA #VaccineDevelopment #Biotechnology #InfectiousDiseases #PharmaPartnerships

Novavax on Friday said it has signed a multibillion-dollar licensing deal with Sanofi to co-commercialize the company’s Covid vaccine and develop combination shots targeting Covid and the flu, among other efforts. Here’s why this is important: Novavax CEO John Jacobs told me in an interview that the deal allows the struggling vaccine maker to lift its “going concern” warning, which it issued at the start of 2023 due to having doubts about its ability to survive. Shares of Novavax jumped more than 130% following the announcement. Part of the deal allows Sanofi to use Novavax’s Covid shot and flagship vaccine technology, Matrix-M adjuvant, to develop new vaccine products. More on the deal and my conversation with Jacobs in my latest: #Novavax #Sanofi #Covid #vaccine #pharma #biotech https://lnkd.in/gnm6r3hu

DNA fragments detected in monovalent and bivalent Pfizer/BioNTech and Moderna modRNA COVID-19 vaccines from Ontario, Canada: Exploratory dose-response relationship with serious adverse events It's an honour to be a part of a great team of scientists investigating the levels of residual DNA in Pfizer and Moderna COVID vaccines in Canada. Even the new Moderna XBB.1.5 contains residual DNA. Read about it here: https://lnkd.in/ey7p4RaX

GSK is taking a monumental step forward in its vaccine ambitions with the launch of RSV shot, AREXVY (Respiratory Syncytial Virus Vaccine, Adjuvanted). An investment of over 250 million euros has been poured in, pushing the boundaries of vaccine accessibility and effectiveness. However, aside from just belgium, GSK has also made vaccine production investment in Singapore too projected to start commercial production in 2027. What does this means? It means that with new facility, GSK is looking to lyophilize tens of millions of doses every year and pushing the boundaries of vaccine accessibility. This is pretty interesting as GSK will be competing with Pfizer's Abrysvo in Respiratory Syncytial Virus (RSV) care to gain market share. Mason & Co #GSK #pharmanews #manufacturing #expansion #rsv #clinicaldevelopment #vaccines #vaccinedevelopment #vaccineresearch https://lnkd.in/gXvkcFDM

We announced today positive interim data from the ongoing Phase 2 study assessing monovalent and bivalent modified vaccine candidates against COVID-19. Results from the formal interim analysis showed that both vaccine candidates using CureVac’s proprietary second-generation mRNA backbone produced meaningful immune responses and favorable reactogenicity profiles across all tested doses, including the lowest tested dose. All three of the dose levels tested were below those used in mRNA-based COVID-19 vaccines licensed in the U.S. and EU. https://lnkd.in/es9jyNn8 #curevac #mRNA #GSK #CVAC #theRNApeople CureVac Announces Positive Phase 2 Interim Data from COVID-19 Vaccine Development Program in Collaboration with GSK Providing Strong Validation of Proprietary Technology Platformcurevac.com • 1 min read

InVitria CEO Scott Deeter to Present on the Development of a Safe and Effective Vaccine for Prevention of Zaire Ebolavirus at World Vaccine Congress Europe! InVitria CEO and Founder Scott Deeter will be presenting on October 18th, 2023. This vaccine was approved by the FDA and EMA and utilizes #Exbumin, recombinant albumin, made by InVitria, Inc., as a final formulation excipient. This is a milestone for the innovative use of recombinant albumin rather than blood-derived human serum albumin. Exbumin offers several advantages, including: - Improved performance and quality in stabilizing biologics - Sustainably sourced; - Lot-to-lot consistency of a recombinant product; and - Cost-effectiveness at commercial scale. Deeter's presentation will highlight the critical role of Exbumin in the development of this life-saving vaccine and its potential to revolutionize the way biologics are formulated and manufactured. If you are attending the World Vaccine Congress Europe, be sure to attend Deeter's presentation to learn more about this exciting new technology and its potential to impact the future of vaccine development and manufacturing. #WVCEU #EbolaVaccine #Exbumin #RecombinantAlbumin #Vaccinenation #CMC

𝗩𝗮𝗰𝗰𝗶𝗻𝗲 𝗡𝗲𝘄𝘀: More Happening in the Biologics Space... By 2027, British Pharma company GSK will open it's brand new facility in Belgium, where the respiratory syncytial virus (RSV) shot Arexvy will be manufactured. Belgium has already become a manufacturing hub for vaccines in previous years, as it hosts two other GSK vaccine sites in Rixensart and Gembloux, as well as a Pfizer site in Puurs. A spokesperson mentioned that “The ambition is to have tens of millions of doses lyophilized each year" and will follow a similar launch pattern as Shingrix (their previous vaccine against Shingles). #pharmaceuticals #vaccine #vaccines #biologics #drugdevelopment #largemolecules #manufacturing #belgium #europe

In the relentless pursuit of combating COVID-19, Regeneron is leading the charge with a visionary approach that goes beyond traditional boundaries. This article takes us on a journey through their innovative strides, unraveling the strategic fusion of cutting-edge technology and biomedical expertise. From vaccine development to the creation of potent monoclonal antibodies, Regeneron's project showcases an unwavering commitment to global health. The implications of Regeneron's work extend far beyond COVID-19, hinting at a paradigm shift in how we approach infectious diseases and biopharmaceutical solutions. #Biopharma #HealthcareInnovation #COVID19Research #MedicalAdvances #Covid19 #proteins #antibodies