Intravacc BV

CeraVx BV successful bid to acquire key micro needle technology from MLTManagement team:Dr. Jan Groen as CEO,Dinja Oosterhof , PhD as Sr. Director R&DJelte Meulenaar ,PharmD, PhD as COOSupervisory Board:Mr Bart van Zijll Langhout, PhD, ChairmanMr Harry Flore, PhDMr Ivo Ploemen, PhD LEIDEN, NETHERLANDS / ACCESSWIRE / December 9, 2024 / CeraVx B.V., a global biotechnology company focused on developing and commercialising a proprietary drug delivery platform, today announced its emergence from stealth mode following a successful bid to acquire key microneedle technology assets from MyLife Technologies B.V. (MLT) and the appointment of its management team and members of the supervisory board.CeraMaps, the company's drug delivery platform, is based on ceramic microneedle array patches (CeraMAPs™). This technology was initially developed at the University of Twente's MESA+ Institute for Nanotechnology, The Netherlands. In 2012, MLT, a spin-off from the university, began developing a lab-scale production process for high-quality ceramic microneedle patches and conducted in-vivo proof-of-concept studies using the drug delivery platform. These studies evaluated various biomolecules, demonstrating strong antibody immune responses in animals. In June 2024, MLT filed for bankruptcy.The newly established, VC-backed company, CeraVx B.V., aims to revolutionise drug delivery systems with its innovative CeraMaps platform by offering safe and effective intradermal drug delivery solutions. The company seeks to enhance patients' quality of life by creating pain-free, precise, and environmentally sustainable delivery systems, enabling seamless access to critical medications and vaccines through partnerships with leading biotech and pharmaceutical companies.CeraVx's management team includes industry experts: Dr. Jan Groen, former Chairman and CEO of Intravacc; Sr. Director R&D Dinja Oosterhof, former Vice President of R&D at Intravacc; and COO Jelte Meulenaar, PharmD, former Programme Director at MLT. The development of the CeraVx core platform CeraMAPs will headed by two ceramic technology experts Francesca Tana PhD and Charlotte Schausten PhD.The newly appointed Supervisory Board members are Mr Bart van Zijll Langhout, (Chairman), current Chairman of the Leiden Bio Science Park Foundation; Harry Flore, former CEO of Halix; and Ivo Ploemen,, Co-CEO of Praetorian Bio Inc. All board members have extensive experience in the vaccine industry.Valentijn Borstlap managing director of Aorta Holding B.V. stated:"We are thrilled to announce the appointment of an exceptional management team and supervisory board at CeraVx. bringing unparalleled leadership and expertise to the company, all with an impressive track record in the biotechnology and vaccine industries. With their collective experience, we are confident that CeraVx will be at the forefront of revolutionising drug delivery through its innovative ceramic microneedle platform."About the Microneedle MarketThe global market for microneedles, including ceramic microneedles, is showing a steady growth. By 2026, the overall microneedle market is expected to reach approximately $1.7 billion, with an annual growth rate (CAGR) of 3.9% since 2021. This growth is driven by the rising adoption of microneedles for drug delivery, diagnostics, and dermatology, along with increasing interest in minimally invasive treatments.About CeraVxCeraVx B.V. is a privately held global biotechnology company developing and commercializing a proprietary drug delivery platform based on a ceramic micro-needle array patches (CeraMAPs™). The CeraMaps technology was initially developed at the University of Twente, MESA+, Institute for Nanotechnology, The Netherlands. The company is focussing on prophylactic and therapeutic vaccines. In 2024 CeraVx acquired the proprietary micro-needle technology from MLT.About CeraMAPs™CeraMaps are nanometre-scale microneedles made from biocompatible, inert ceramic materials, integrated into a patch designed for intradermal drug delivery through the skin. Each CeraMaps patch contains approximately one hundred microscopic needles, which only penetrate the outermost layer of the skin where abundant immune cells naturally reside. Importantly, the needles do not reach sensitive nerves or blood vessels, making the administration of vaccines or medicines completely painless. Intradermal delivery through CeraMaps can use up to 5 to 20 times less active ingredient compared to traditional intramuscular injections (IM). Additional advantages of the CeraMaps patch over IM injections include painlessness, the possibility for self-administration, non-invasiveness, and improved drug absorption. CeraVx has developed two types of microneedle patches: CeraPore (porous microneedles) and CeraShovel (solid microneedles). The company also offers customised CeraMaps patches, varying in needle density, array dimensions, and cavity structure.For further details, please visit our website at https://ceravx.bio/Contact infoCeraVx B.VDr. Jan Groen, CEOE: [email protected]SOURCE: CeraVx

Primrose Bio’s expertise in engineering high-performance RNA polymerases will aid in enhancing the yield of mRNA synthesis. Credit: Photo-Video Lab/Shutterstock. Primrose Bio has entered a strategic partnership with ExPLoRNA Therapeutics aimed at advancing the development and marketing of mRNA medicines. Primrose Bio brings to the partnership its expertise in engineering high-performance RNA polymerases (Prima RNApols), which enhance the yield of mRNA synthesis. This technology not only reduces the presence of double-stranded RNA (dsRNA) but also lowers production costs, meeting the stringent manufacturing demands for various mRNA applications. ExPLoRNA Therapeutics specialises in mRNA innovations, focusing on new cap analogues that are crucial for successful protein production. Its technology boosts protein production, minimises dsRNA formation and reduces in vitro transcription (IVT) costs, offering notable improvements in therapeutic effectiveness. See Also: RegenxBio touts positive data for rare disease drug RGX-121 Ocaliva approval in Europe withdrawn following data re-assessment Primrose Bio CEO Helge Zieler stated: “We are excited to work with ExPLoRNA to bring industry-leading mRNA cap analogs to the market and pairing them with Primrose Bio’s RNA polymerases. “This partnership will result in broader manufacturing and design options for companies developing mRNA therapeutics and vaccines, facilitating access to the most efficient capping chemistry available.” The collaboration between Primrose Bio and ExPLoRNA will lead to the joint development and offering of RNA polymerases and capping compounds that are co-optimised to improve mRNA quality, manufacturing efficiency and the safety and efficacy of therapies. It intends to offer manufacturing solutions and new design options through advanced capping chemistry to mRNA drug developers. ExPLoRNA Therapeutics CEO Jacek Jemielity said: “Through joining forces, we’ll advance the mRNA as a modality from the first applications to the next generation. “We aim at creating the best synergies between our cap analogs and novel polymerases to surpass current manufacturing process and what is achievable with mRNA today.” In March 2024, Primrose Bio and contract development and manufacturing organisation Intravacc announced a strategic collaboration to enhance conjugate vaccine development and supply. mRNA vaccine coverage on Pharmaceutical Technology (Or Clinical Trials Arena) is supported by Trilink . Editorial content is independently produced and follows the highest standards of journalistic integrity. Topic sponsors are not involved in the creation of editorial content. Free Whitepaper mRNA capping: low cost, high reward Are you aware of the latest mRNA capping techniques? The success of mRNA-based Covid vaccines has seen the technology boom in popularity – but capping is an essential part of the manufacturing process, and pharmaceutical firms face a range of choices on how to do it. This free whitepaper assesses differences in price, time, complexity and availability for the methods on offer – and provides essential insights on TriLink’s trailblazing CleanCap® approach. Fill in your details to find out more. Thank you. You will receive an email shortly. Please check your inbox to download the Whitepaper. By Trilink Thematic By downloading this Whitepaper, you acknowledge that GlobalData may share your information with Trilink Thematic and that your personal data will be used as described in their Privacy Policy

2024年8月29日，科兴控股生物技术有限公司（以下简称“SINOVAC科兴”）旗下北京科兴生物制品有限公司研制的5人份Sabin株脊髓灰质炎灭活疫苗（Vero细胞）（以下简称"5人份sIPV"）通过世界卫生组织（WHO）预认证（PQ）。与单人份sIPV相比，5人份sIPV可有效降低免疫接种成本，目前已被列为WHO消灭脊灰行动计划的急需品种。SINOVAC科兴5人份sIPV将助力全球消灭脊灰“最后一公里”。 脊髓灰质炎是一种高发于5岁以下婴幼儿的高度传染性疾病。自1988年世界卫生大会启动全球消灭脊髓灰质炎行动（GPEI）以来，全球脊髓灰质炎的发病已经减少了99%以上，有野生型脊髓灰质炎病毒（WPV）所致的脊髓灰质炎流行的国家也从125个减少到了2个（截至2024年8月，数据源自GPEI）。 但由于疫苗可及性原因，使得全球消灭脊灰的行动面临巨大挑战。为此，WHO委托荷兰Intravacc开发减毒株灭活疫苗，向全球合格厂商进行技术转移。SINOVAC科兴作为全球6家厂商之一获得技术转移资格，并于2012年开始sIPV疫苗研制工作。2021年7月，SINOVAC科兴研制的单人份sIPV获得国家药品监督管理局颁发的药品注册批件，并于2022年6月通过WHO预认证。2024年4月，SINOVAC科兴5人份sIPV在国内获批上市。 2024年7月8日，世界卫生组织总干事召集了《国际卫生条例（2005）》下关于脊髓灰质炎病毒国际传播的第39次紧急委员会会议。委员会一致认为，脊髓灰质炎病毒的国际传播风险仍然构成国际关注的突发公共卫生事件（PHEIC），并建议将临时建议延长三个月。同时委员会指出，非洲地区有20个国家尚未在其常规免疫计划中引入第二剂IPV。此外，一些受循环疫苗衍生脊髓灰质炎病毒（cVDPV）疫情影响的国家仍然存在第一剂IPV覆盖率低的问题。必须采取紧急措施，在剩余国家的常规免疫中引入第二剂IPV，并提高首剂IPV的覆盖率，特别是在受疫情影响的国家。 WHO关于脊髓灰质炎的实况报道 截至2024年8月 重要事实： 脊灰（脊髓灰质炎）主要影响五岁以下儿童。 每200例感染病例中会有一例出现不可逆转的瘫痪。在瘫痪病例中，5-10%的患者因呼吸肌麻痹而死亡。 1988年以来，野生脊灰病毒引起的病例数减少了99%以上，从在逾125个流行国家中估计的35万例减至仅剩两个流行国家（截至2024年8月）。 只要还有一名儿童染有脊灰病毒，所有国家的儿童就仍有感染该疾病的危险。如果不能在这些最后剩余的脊灰盘踞点消灭它，就可能导致这种疾病在全球范围内死灰复燃。 在多数国家，全球性工作通过建立有效的监测和免疫系统拓展了能力，从而能对付其它传染病。 概述 1988年，世界卫生大会通过了一项全世界消灭脊灰决议。这标志着由国家政府、世卫组织、国际扶轮社、美国疾病控制和预防中心以及联合国儿童基金会率先发起，后来又有比尔及梅琳达·盖茨基金会和全球疫苗免疫联盟加入的全球消灭脊灰行动（GPEI）正式启动。自那时起，全球脊髓灰质炎发病率已经减少了99%，继1980年天花之后，世界有史以来第二次站在了消灭人类疾病的门槛上。 1988年以来，野生脊灰病毒病例减少了99%以上，从当时在逾125个流行国家中估计的35万例，减至仅剩阿富汗和巴基斯坦两个国家仍有脊灰野病毒流行。 然而，据GPEI数据，2023年全球仍有数十个国家报告了超过500例因循环疫苗衍生脊灰病毒（cVDPV）所致的驰缓性麻痹（AFP）病例。巴勒斯坦卫生部8月16日发表声明说，加沙地带确认一例脊髓灰质炎病例，而该地区已经在25年前根除脊灰野病毒。8月31日，巴勒斯坦加沙地带卫生部门宣布，脊髓灰质炎疫苗接种行动将于9月1日起在加沙地带大范围展开。此次大规模疫苗接种对象为从新生儿到10岁的儿童，按计划，将有64万名加沙地带儿童参与接种，每名儿童共接种2次，间隔4周。 症状和风险 脊灰是一种病毒引起的传染性很强的疾病。它侵袭神经系统，可在数小时内造成全面性瘫痪。病毒主要通过粪口途径，或者在不太常见情况下，通过常见方式（如受到污染的水或食物）在人际间传播并在肠道内繁殖。初期症状包括发热、疲乏、头痛、呕吐、颈部僵硬以及四肢疼痛。每200例感染病例中会有1例出现不可逆转的瘫痪（通常是腿部）。在瘫痪病例中，5-10%的患者因呼吸肌麻痹而死亡。 脊灰主要影响五岁以下儿童。然而，没有接种疫苗的任何年龄的人都可能感染这一疾病。 脊灰没有特效药，只能进行预防。多次接种脊灰疫苗，可使儿童获得终身保护。现有两种疫苗可用：口服脊灰疫苗和灭活脊灰疫苗。两种疫苗都安全有效，根据当地的流行病学和免疫规划情况，在世界各地以不同的组合方式使用，以确保能够向民众提供尽可能好的保护。 消灭 消灭脊灰战略在得到充分实施时会发挥作用。世界上大多数国家成功消灭了这一疾病，就清楚地表明了这一点。 《2022-2026年消灭脊灰战略》为确保建设一个没有各种脊灰病毒的持久和可持续的世界制定了路线图，且目前正在开展过渡和脊灰认证后工作，以确保为消灭脊灰而建立的基础设施将在该病消失很长时间后继续为更广泛的公共卫生工作带来裨益。 成功的关键是确保该战略在所有方面都得到充分实施，并获得充足资源。然而，要是不能落实所提战略方法会导致病毒持续传播。在阿富汗和巴基斯坦的一些地区，野生脊灰病毒的地方传播仍在继续。如果不能将脊灰在这些最后剩余地区加以遏制，就可能导致这种疾病在全球范围内死灰复燃。这就是为何必须确保一劳永逸地彻底消灭脊灰。 消灭脊灰后，全世界可庆祝这一重大全球公益产品，所有人无论身处何地都能平等受益。经济学建模发现，消灭脊灰可至少节省400-500亿美元，主要体现在低收入国家。最为重要的是，成功消灭脊灰意味着不会再有儿童经历脊髓灰质炎所致终身麻痹带来的痛苦。 根据《国际卫生条例》，消灭脊灰的全球努力已被宣布为国际关注的公共卫生行动，《国际卫生条例》突发事件委员会向受脊灰炎病毒传播影响或面临该病再次出现的高风险国家发布了临时建议。 脊灰工作继续对更广泛的公共卫生努力提供支持，包括帮助应对自然灾害、人道主义紧急情况、干旱、地震、其他传染病疫情，并为更广泛的公共卫生行动促进疾病监测。全球消灭脊灰行动继续支持应对全球COVID-19大流行，包括帮助开展疾病监测、提高实验室能力以及疫苗采用和推广。 世卫组织的应对 世卫组织与全球消灭脊灰行动各伙伴一道，继续支持仍受脊灰病毒影响或面临再次出现脊灰的高风险国家实施消灭战略，首先侧重于计划免疫和疾病监测。自全球消灭脊灰行动启动以来，病例数量减少了99%以上。 1994年，世卫组织美洲区域被认证为无脊髓灰质炎。随后，2000年世卫组织西太平洋区域以及2002年6月欧洲区域也获得认证。2014年3月27日，世卫组织东南亚区域被认证为无脊灰地区，这意味着野生脊灰病毒的传播在横跨印度尼西亚和印度的这一11个国家群组中已经得到阻断。2020年，非洲成为第五个获得无野生脊灰病毒认证的区域。 当今有2000多万人可以行走，要不然可能就已瘫痪。通过在开展计划免疫活动期间系统性加服维生素A，估计使150万名儿童的死亡得以避免。 来源：世界卫生组织 - 脊髓灰质炎 https://www.who.int/zh/news-room/fact-sheets/detail/poliomyelitis SINOVAC科兴脊灰灭活疫苗大事记 2012年12月，自荷兰Intravacc公司获得sIPV技术转移资格 2015年，启动sIPV临床研究 2020年，启动世界卫生组织预认证申报工作 2021年，接受世界卫生组织的现场检查 2021年7月12日，sIPV成功在国内获批上市 2022年2月，收到WHO-PQ现场检查通过函 2022年6月2日，单人份sIPV通过世界卫生组织预认证 2024年4月9日，5人份sIPV在国内获批上市 2024年8月29日，5人份sIPV通过WHO预认证 关于SINOVAC科兴脊灰灭活疫苗 SINOVAC科兴的sIPV用于婴幼儿及儿童，主要用于2月龄及以上的婴幼儿，预防由脊髓灰质炎病毒Ⅰ型、Ⅱ型和Ⅲ型导致的脊髓灰质炎。该疫苗基础免疫程序为3剂次，首次免疫从2月龄开始，连续3次，每次间隔至少1个月；18月龄加强免疫一次。Ⅲ期临床研究结果显示，受试者接种该疫苗后0-30天总体不良反应以轻度或中度为主，未见与疫苗接种相关的严重不良事件或罕见不良反应，安全性良好。 SINOVAC科兴自sIPV研发伊始即放眼于全球消灭脊灰行动，应用世界领先技术并使用国际化标准研发和生产疫苗。公司围绕疫苗研发和生产开展的国际合作包括：从世界卫生组织（WHO）获得疫苗病毒毒种和病毒培养细胞种子系，从荷兰Intravacc引进工艺技术，生产用厂房设计，临床血清检测等均与国际专业机构/组织通力合作。sIPV采用SINOVAC科兴国际化标准的质量体系，运用生物反应器搭配微载体技术，与传统工艺相比具有培养规模大、工艺控制更精确、无菌控制风险低等特点。该疫苗不含任何防腐剂和抗生素，从而降低了相关不良反应发生的风险。 关于SINOVAC科兴/产品介绍 科兴控股生物技术有限公司（Sinovac Biotech Ltd.，SINOVAC科兴）是中国领先的生物高新技术企业，以“为人类消除疾病提供疫苗”为使命，致力于人用疫苗及其相关产品的研究、开发、生产和销售，为全球疾病预防控制提供服务。 SINOVAC科兴研制的疫苗主要包括针对病毒性肝炎、流感、肺炎、脊髓灰质炎、水痘、腮腺炎等常见传染病的疫苗以及针对SARS、甲型H5N1高致病性禽流感、甲型H1N1流感大流行、EV71相关手足口病、新型冠状病毒感染等新发、突发传染病的疫苗。公司现有4款疫苗通过世界卫生组织预认证（甲肝灭活疫苗、Sabin株脊髓灰质炎灭活疫苗、水痘减毒活疫苗）或列入紧急使用清单（新型冠状病毒灭活疫苗），疫苗质量管理体系获国际组织和多国药监部门认可。 未来，SINOVAC科兴将继续聚焦于生物医药领域的科学创新，通过自主研发以及对外投资、合作等多种方式推动更多高品质生物医药产品更快地实现产业化落地，用于满足全球的疾病防治需求，助力提升全球健康福祉。