IVX-241

2023年12月12日，阿斯利康宣布将支付8.38亿美元的预付款，收购纳斯达克疫苗上市公司Icosavax及其病毒样颗粒平台技术。此次交易的预付款加上最高或有价值，总和约为11亿美元，比收购前最后60个交易日的Icosavax成交量加权平均价格溢价130%。根据交易条款，阿斯利康将以每股15美元的价格购买Icosavax的所有流通股，并将根据具体的监管和净销售里程碑，质押每股高达5美元的或有价值权利。阿斯利康还将支付约8.38亿美元的预付款，这比Icosavax周一的收盘价溢价43%。Icosavax是总部位于美国西雅图的生物技术公司，其是在突破计算机设计的病毒样粒子技术的基础上成立的，致力于开发针对传染病的安全有效的疫苗。IVX-A12是Icosavax公司的二价候选毒株，由抗呼吸道合胞病毒（RSV）的IVX-121和抗人类偏肺病毒（HMPV）的IVX-241组成，旨在预防这两种感染。VLP导致RSV-F蛋白以其稳定的预融合形式呈现多价。目前该疫苗正在开发用于老年人呼吸道合胞病毒（RSV）和人类偏肺病毒（hMPV）。据Icosavax在本周公布的IVX-A12积极顶线II期数据显示，接种后28天，该候选疫苗可以引发针对RSV和hMPV的强大免疫反应——无论是否使用佐剂。在安全性方面，联合注射通常耐受性良好，大多数全身和局部不良事件的严重程度为轻度或中度。也没有记录在案的发烧、与疫苗相关的严重不良事件或导致停药的毒性病例。该试验的顶线中期安全性和免疫原性数据与先前报道的IVX-A12的I期数据基本一致。而通过收购Icosavax，阿斯利康将入局RSV疫苗市场，成为GSK和辉瑞的潜在竞争对手。其中，GSK的Arexvy是首款FDA授权接种的RSV疫苗，于2023年5月获批上市；辉瑞的Abrysvo则在其后一个月获批上市。据这两家企业2023Q3财报显示，Arexvy首季实现营收7.09亿英镑（约8.70亿美元），全年销售指引9-10亿英镑（约12.6亿美元）；而Abrysvo首季则销售3.75亿美元。RSV疫苗的潜力可见一斑。除了该联合疫苗管线外，据Icosavax官网显示，该公司还布局了RSV疫苗、四价流感疫苗以及二价新冠疫苗等。其中RSV疫苗处于临床I期，后两者则还处于研发早期。此外，阿斯利康还将获得Icosavax专有的病毒样颗粒（VLP）疫苗技术的所有权。据了解，该技术允许“以与病毒结构非常相似的方式高密度、多价显示抗原”。Icosavax认为，使用VLP平台开发的候选疫苗可以诱导比传统的抗原疫苗更强、更持久的免疫反应。阿斯利康疫苗和免疫疗法执行副总裁Iskra Reic在一份声明中表示，Icosavax的VLP平台“有可能改变对严重传染病的预防，包括RSV和hMPV。其补充道，收购Icosavax为阿斯利康提供了“III期准备的先导资产”，以及进一步发现和开发其他针对呼吸道病毒的联合疫苗的技术平台。两家公司预计该交易将于2024年第一季度完成。而收购完成后，Icosavax将与阿斯利康子公司合并。参考资料：[1]AstraZeneca Buys into RSV Vaccine Market with Potential $1.1B Icosavax Purchase.Biospace.Published: Dec 12, 2023 By Tristan Manalac.[2]GSK上调RSV疫苗销售指引！RSV赛道风平浪静70载，如今百亿市场被燃爆.猎药人俱乐部.猎药人俱乐部.2023-12-11.[3]阿斯利康官网、Icosavax官网.相关阅读大卖！辉瑞RSV疫苗首季实现3.75亿美元销售额GSK的RSV疫苗III期试验初步结果积极，适用人群有望扩展至50-59岁！婴儿群体的RSV预防：哪种是最优选的策略？掘金超级蓝海市场，14家布局RSV疫苗的中国企业梳理识别微信二维码，添加生物制品圈小编，符合条件者即可加入生物制品微信群！请注明：姓名+研究方向！版权声明本公众号所有转载文章系出于传递更多信息之目的，且明确注明来源和作者，不希望被转载的媒体或个人可与我们联系(cbplib@163.com)，我们将立即进行删除处理。所有文章仅代表作者观点，不代表本站立场。

Building on expertise in RSV prevention, acquisition will accelerate ambition to deliver portfolio of protective interventions to address high unmet needs in infectious diseases WILMINGTON, DE, USA I December 12, 2023 I AstraZeneca has entered into a definitive agreement to acquire Icosavax, Inc. (NASDAQ: ICVX), a US-based clinical-stage biopharmaceutical company focused on developing differentiated, high-potential vaccines using an innovative, protein virus-like particle (VLP) platform. The proposed acquisition will build on AstraZeneca’s expertise in respiratory syncytial virus (RSV), strengthening AstraZeneca’s Vaccines & Immune Therapies late-stage pipeline with Icosavax’s lead investigational vaccine candidate, IVX-A12. IVX-A12 is a potential first-in- class, Phase III-ready, combination protein VLP vaccine which targets both RSV and human metapneumovirus (hMPV), two leading causes of severe respiratory infection and hospitalisation in adults 60 years of age and older and those with chronic conditions such as cardiovascular, renal and respiratory disease. 1-3 There are currently no treatments or preventative therapies for hMPV and no combination vaccines for RSV. 4 IVX-A12 is the most advanced investigational vaccine targeting both RSV and hMPV and has a differentiated profile versus currently approved RSV vaccines. Phase II data demonstrate that IVX-A12 elicits robust immune responses against both RSV and hMPV one month after vaccination and reconfirm previous immunogenicity data seen in the Phase I trial. 5 As VLP vaccines mimic how naturally occurring viruses appear to the body’s immune system, they may offer potential benefits over non-VLP vaccines, including a stronger immune response, greater breadth of protection, greater durability requiring fewer boosters and, compared to the current adjuvanted RSV vaccine, a lower incidence of side effects. 6 Alongside Icosavax’s proprietary technology and leadership in protein design, the acquisition is expected to also bring their expertise and capabilities in protein virus-like particle science and development to AstraZeneca to support the progression of IVX-A12 and other differentiated VLP vaccines for high-burden respiratory infections. Iskra Reic, Executive Vice President, Vaccines & Immune Therapies, AstraZeneca, said: “This virus-like particle vaccine technology has the potential to transform prevention against severe infectious diseases, including RSV and hMPV. With the addition of Icosavax’s Phase III-ready lead asset to our late-stage pipeline, we will have a differentiated, advanced investigational vaccine, and a platform for further development of combination vaccines against respiratory viruses. This aligns with our strategy to deliver a portfolio of therapies to address high unmet needs in infectious diseases, and our ambition to protect the most vulnerable patients who have high risk of severe outcomes.” Adam Simpson, Chief Executive officer, Icosavax, said: “We are pleased to announce the proposed acquisition of Icosavax by AstraZeneca as we believe it offers the opportunity to accelerate, and expand access to, our potential first-in-class combination vaccine for older adults at risk of RSV and hMPV. We look forward to combining our skills and expertise in advancing the development of IVX-A12 with AstraZeneca’s decades of experience in RSV, resources, and capabilities in late-stage development.” Financial considerations Under the terms of the agreement, AstraZeneca, through a subsidiary, will initiate a tender offer to acquire all of Icosavax’s outstanding shares for a price of $15.00 per share in cash at closing, plus a non-tradable contingent value right for up to $5.00 per share in cash payable upon achievement of a specified regulatory milestone and a sales milestone. The upfront cash portion of the consideration represents a transaction value of approximately $0.8bn, a 43% premium to Icosavax’s closing market price on 11 th December 2023 and a 73% premium to the 60-day volume-weighted average price (VWAP) of $8.68 before this announcement. Combined, the upfront and maximum potential contingent value payments represent, if achieved, a transaction value of approximately $1.1bn, a 91% premium to Icosavax’s closing market price on 11 th December 2023 and a 130% premium to the 60-day VWAP. As part of the transaction, AstraZeneca will acquire the cash and marketable securities on Icosavax’s balance sheet, which totaled $229m as of 30 th September 2023. Notes Icosavax Icosavax is a biopharmaceutical company leveraging its innovative VLP platform technology to develop vaccines against infectious diseases, with an initial focus on life-threatening respiratory diseases and a vision for combination and pan-respiratory vaccines. Icosavax’s VLP platform incorporates antigen design capabilities and technology to enable multivalent, particle-based display of complex viral antigens, which it believes will induce broad, robust, and durable protection against the specific viruses targeted. Icosavax’s lead program is a combination vaccine candidate targeting respiratory syncytial virus (RSV) and human metapneumovirus (hMPV). Its pipeline includes additional candidates that provide optionality as potential components of future combination and pan-respiratory vaccines, including influenza and SARS-CoV-2. Icosavax was formed in 2017 to advance the breakthrough VLP technology from the Institute for Protein Design at the University of Washington with the goal to discover, develop, and commercialize vaccines against infectious diseases. Icosavax is located in Seattle. RSV and hMPV in older adults RSV is a common, contagious virus that is a major cause of lower respiratory tract infection in adults. 7 Most adult RSV disease cases occur among older adults, with an estimated 60,000-160,000 hospitalisations and 6,000-10,000 deaths annually among US adults >65 years. 8 RSV infection can cause serious complications such as pneumonia or exacerbation of congestive heart failure, asthma, and chronic obstructive pulmonary disease. 7 hMPV causes disease very similar to RSV, including upper and lower respiratory tract infections that can be more severe in young children, older adults, and people with weakened immune systems. 4 Adults with hMPV infection may have viral pneumonia, worsening asthma, or COPD symptoms. 9 Data support similar morbidity and mortality for hMPV and RSV. 2 There are currently no treatment or prevention options for hMPV. 4 IVX-A12 IVX-A12 is a liquid, refrigerator-stable formulation comprised of IVX-121, Icosavax’s RSV prefusion F protein VLP vaccine candidate, and IVX-241, Icosavax’s hMPV prefusion F protein VLP vaccine candidate. In Icosavax’s Phase II trial, IVX-A12 showed robust immune responses across RSV and hMPV antibodies, reconfirming previous immunogenicity data seen in the smaller Phase I trial. The data are the first to demonstrate hMPV immune response in a Phase II combination vaccine trial. IVX-A12 was generally well-tolerated in the trial, with a safety profile similar to that seen in the Phase I trial. 5 IVX-A12 has been granted Fast Track Designation from the US Food and Drug Administration, a programme designed to facilitate the development and expedite the review of investigational drugs to treat serious conditions and fulfill an unmet medical need. 10 Icosavax VLP technology VLPs are a proven technology with multiple products on the market, including vaccines for human papillomavirus and hepatitis B. 6 While currently available vaccines utilise the few proteins that naturally fold into VLPs, 11 the Icosavax protein VLP platform builds on that success with intentionally designed VLPs to create highly differentiated vaccines. VLPs are designed to resemble the structure of viruses, with high-density, multivalent display of antigens. 6,11 This technology is believed to induce a stronger and more durable immune response versus traditional soluble antigens. 6,11 Transaction details The closing of the tender offer will be subject to certain conditions, including the tender of shares representing at least a majority of the total number of Icosavax’s outstanding shares, and other customary closing conditions and regulatory clearances. Upon the successful completion of the tender offer, AstraZeneca’s acquisition subsidiary will be merged with and into Icosavax and any remaining shares of common stock of Icosavax will be cancelled and converted into the right to receive the same merger consideration (including the contingent value right) per share payable in the tender offer. Subject to the satisfaction of the conditions in the merger agreement, the acquisition is expected to close in the first quarter of 2024. Important information about the tender offer The tender offer for the outstanding common stock of the Company has not yet commenced. This communication does not constitute a recommendation, an offer to purchase or a solicitation of an offer to sell the Company’s securities. An offer to purchase shares of the Company’s common stock will only be made pursuant to an Offer to Purchase and related tender offer materials. At the time the tender offer is commenced, AstraZeneca PLC (AstraZeneca), AstraZeneca Finance and Holdings Inc. and Isochrone Merger Sub Inc., a wholly owned indirect subsidiary of AstraZeneca, will file a Tender Offer Statement on Schedule TO with the Securities and Exchange Commission (the SEC) and thereafter the Company will file a Solicitation/Recommendation Statement on Schedule 14D-9 with the SEC with respect to the tender offer. The tender offer materials (including the Offer to Purchase, a related Letter of Transmittal and other tender offer documents) and the Solicitation/Recommendation Statement on Schedule 14D-9 will contain important information. The Company’s stockholders are urged to read these documents (including the Offer to Purchase and related Letter of Transmittal and certain other documents), and the Solicitation/Recommendation Statement, as may be amended from time to time, carefully when they become available because they will contain important information that they should consider before making any decision regarding tendering their shares of common stock. The tender offer materials and the Solicitation/Recommendation Statement will be made available for free at the SEC’s website at www.sec.gov . Copies of the documents filed with the SEC by AstraZeneca may be obtained at no charge on the investor relations page of AstraZeneca’s internet website at www.astrazeneca.com/investors . Copies of the documents filed with the SEC by Icosavax may be obtained at no charge under the “Investors” section of Icosavax’s internet website at www.Icosavax.com . AstraZeneca AstraZeneca (LSE/STO/Nasdaq: AZN) is a global, science-led biopharmaceutical company that focuses on the discovery, development, and commercialisation of prescription medicines in Oncology, Rare Diseases, and BioPharmaceuticals, including Cardiovascular, Renal & Metabolism, and Respiratory & Immunology. Based in Cambridge, UK, AstraZeneca operates in over 100 countries and its innovative medicines are used by millions of patients worldwide. Please visit astrazeneca.com and follow the Company on social media @AstraZeneca . References SOURCE: AstraZeneca