Minervax ApS

COPENHAGEN, Denmark and MUNICH, Germany I September 17, 2024 I MinervaX ApS, a privately held Danish biotechnology company developing a novel, prophylactic vaccine against Group B Streptococcus (GBS) and Wacker Biotech, a contract development and manufacturing organization (CDMO), wholly owned subsidiary of Wacker Chemie AG, today announce a collaboration to manufacture MinervaX’s active protein ingredients of its GBS vaccine. GBS is responsible for nearly 50 percent of all life-threatening infections in newborns. At any given time, some 15-25 percent of the population, including pregnant people are spontaneously colonized with GBS, and during pregnancy they run the risk of transmitting the bacteria to their child in the womb, during birth and/or during the first months of life. GBS colonization may lead to late abortions, premature delivery, or stillbirth and in the newborn child, may result in sepsis, pneumonia or meningitis, all of which carry a significant risk of severe morbidity, long- term disability or death. With no general implemented and fully protective preventative treatment available for GBS, this underlines the unmet medical need of developing and providing a vaccine to prevent adverse pregnancy outcomes and life- threatening infections in infants caused by GBS. Furthermore, older adults and adults with certain co-morbidities such as diabetes or obesity are also at an increased risk of severe GBS infections and form a second population which would benefit from a prophylactic vaccine against this potentially fatal disease. MinervaX’s lead vaccine candidate, is a novel protein-only vaccine, based on fusions of highly immunogenic and proactive protein domains from selected surface proteins of GBS. The company is strongly committed and dedicated to advancing its novel vaccine and has successfully completed two Phase II clinical trials of its maternal vaccine against GBS and is in preparation to commence Phase III clinical trials in this indication. Data from MinervaX’s GBS vaccine is very positive, demonstrating an acceptable safety profile in pregnant people and their infants, with high immunogenicity, leading to functionally active antibodies, with the potential for broad coverage and protection, alleviating the need for excessive use of antibiotics. Wacker Biotech will manufacture the active ingredients of MinervaX’s novel vaccine candidate, alongside performing the technology transfer, process validation and process characterization activities for later commercial manufacturing. Subsequently, Wacker Biotech will perform all key functions critical to ensure stable commercial supply at its site in Amsterdam, The Netherlands. Per Fischer, CEO of MinervaX, said: “GBS can be life-threatening for newborn babies and is linked to over half a million preterm births annually. Following the EUR 54 million financing last year, our team is advancing the development of our novel prophylactic vaccine against GBS for the benefit of all populations at risk, worldwide. Wacker Biotech is a robust manufacturing partner with a strong track record in late clinical and commercial supply and we look forward to collaborating with the team ahead of commencing Phase III studies.” Ronald Eulenberger, Managing Director of Wacker Biotech B.V. in Amsterdam, stated: “With our strong background in E. coli processes, process characterization, and process validation experiences, we at Wacker Biotech are perfectly suited to support MinervaX with its ongoing program for the prevention of invasive GBS disease.” Details of MinervaX’s completed Phase II clinical trials in pregnant people can be found at https://clinicaltrials.gov/ under the identifiers NCT04596878 and NCT05154578. In addition to pregnant people, MinervaX is also pursuing Phase I development of its novel GBS vaccine in older adults, under identifier NCT05782179. Notes to Editors: About MinervaX MinervaX is a Danish biotechnology company, established in 2010 to develop a prophylactic vaccine against Group B Streptococcus (GBS), based on research from Lund University. MinervaX is developing a GBS vaccine for maternal immunization, and also for vaccination of older/at risk adults. Phase II clinical data from its maternal vaccination program suggest a high efficacy, based on the preliminary Correlate of Protection data from a natural history study. MinervaX’s GBS vaccine is a protein-only vaccine based on fusions of highly immunogenic and protective protein domains from selected surface proteins of GBS, the Alpha-like protein family (AIpN). Given the broad distribution of proteins contained in the vaccine on GBS strains globally, it is expected that MinervaX’s GBS vaccine will confer protection against virtually 100% of all GBS isolates. www.minervax.com About Wacker Biotech Wacker Biotech is a full-service contract manufacturer of therapeutic proteins, live biopharmaceutical products (LBPs), plasmid DNA (pDNA), messenger ribonucleic acid (mRNA) and vaccines based on microbial systems. Wacker Biotech’s portfolio extends from strain/process development and analytical testing through to production for clinical and commercial applications. Wacker Biotech operates three GMP-compliant, FDA- and EMA-certified production plants at its Jena and Halle sites in Germany and in Amsterdam in the Netherlands. In addition, Wacker Biotech has had a plant in San Diego (Wacker Biotech US Inc.) since February 2021. Wacker Biotech GmbH, Wacker Biotech B.V. and Wacker Biotech US Inc. are wholly owned subsidiaries of Munich-based Wacker Chemie AG. SOURCE: MinervaX

Exsilio Therapeutics，一家致力于开发针对多种疾病的基因组药物的生物技术企业，在6月25日于波士顿宣布，其A轮融资成功筹集到8200万美元。此次融资由诺华风险投资基金和Delos Capital联合领投，同时获得了OrbiMed、Insight Partners、J.P. Morgan Life Sciences Private Capital、CRISPR Therapeutics、Innovation Endeavors、Invus、Arc Ventures和Deep Insight等知名投资机构的跟投支持。 Exsilio的种子轮投资由OrbiMed提供，公司目前由前Moderna首席医学官、现任OrbiMed合伙人的Tal Zaks博士担任临时CEO。Zaks博士在生物技术领域拥有丰富的经验，同时也在PIC Therapeutics、iECURE、Convergent Therapeutics和Minervax等多家公司担任董事。 公司计划将所筹资金用于推动其基因组药物的研发，这些药物基于天然存在的可编程遗传元件，通过信使核糖核酸中间模板(mRNA intermediates)实现新基因在细胞中的精确插入。Exsilio的跨学科团队已经建立了一个结合预测性计算机建模和实验研究的平台，用于发现和设计这些遗传元件，确保治疗基因能够安全地整合到细胞的特定位置。 得益于mRNA编码的药物特性，Exsilio可以利用现有的脂质纳米颗粒(LNP)递送平台，这一平台已被证明安全、高效、可扩展，并且成本效益高，支持药物的重复给药和剂量调整。目前，Exsilio正在针对遗传性疾病、癌症以及自身免疫性疾病进行药物开发。 Exsilio董事长兼临时首席执行官Tal Zaks博士表示：“mRNA药物的开发策略类似于软件工程，为新药的创造提供了灵活性。Exsilio采用了mRNA技术的优势，并进一步推进，通过编码能够永久整合的基因，为实现长期治愈而非仅提供短期疗效打开了大门。我们的能力在于能够通过重复和剂量调节的方式，将完整的基因插入，这使我们能够针对遗传性疾病进行治疗，不受患者个体突变的影响。这笔资金将助力我们加速基因组药物的研发进程，并筛选出有潜力的候选药物，以期为患者带来他们迫切需要的新治疗选项。” 诺华风险基金董事总经理兼Exsilio董事会成员Aaron Nelson表示：“我们对Exsilio的基因组药物策略深感着迷，它能够安全且经济高效地实现大型基因的整合。得益于这笔重大的资金注入，Exsilio将具备筛选和推进针对棘手疾病的有希望的候选药物的能力。” Delos Capital管理合伙人、Exsilio董事会成员Henry Chen表示：“我们坚信，将治疗基因安全且持久地融入患者基因组的愿景，需要依赖于RNA有效载荷，这些载荷能够借助经过临床验证的非病毒性基因传递技术。Exsilio汇集了一群具有独特视角和专长的人才，他们将共同助力构建基因组医学这一新兴领域的基石。” 原文来源：mRNA biotech Exsilio breaks cover with Tal Zaks at the helm (fiercebiotech.com) 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。

A lipid nanoparticle siRNA delivery system used in mRNA therapeutics If you're going to be a new biotech in mRNA, it helps to have the type of technology that can solve a big problem—and draw a big name. That's what Exsilio Therapeutics, which broke cover today with $82 million to create new genomic medicines sprinkled with a side of mRNA, has done.  The genetic disease biotech's temporary CEO is none other than Tal Zaks, M.D., Ph.D., of Moderna fame. Since leaving the mRNA powerhouse, Zaks has been spending his time on the investor side, he says. He currently serves—and will continue to serve—as a partner at investment firm OrbiMed, as well as holding director seats at PIC Therapeutics, iECURE, Convergent Therapeutics and Minervax. But Exsilio’s genomic medicines approach lured him off the bench and into the C-suite again. “I got introduced to this company and believed that it was in the sweet spot of a problem we need to solve and I had a sense of a mission given my experience with mRNA lipid nanoparticles,” Zaks said in an interview. “I thought I could be able to contribute to the growth of this company.”  Exsilio will be looking for a full-time leader, but in the meantime, Zaks will be there “absolutely as long as necessary to make sure that the potential of that company is brought to bear, put it this way.” Exsilio is developing genomic medicines using naturally occurring, programmable genetic elements that can insert new genes into the cell through mRNA intermediates. The platform uses in-silico modeling and wet lab-based experimentation to develop therapeutic genes. Since the resulting medicines are encoded with mRNA, they use existing lipid nanoparticle platforms that have been shown to be safe, scalable and cost-effective. Zaks was swayed by the potential for Exsilio's technology to insert genes into safe harbor sites, which can accommodate the new genetic material and ensure predictable functionality and no off-sight alterations. “I am a medical oncologist by training. One of the reasons this is my first foray truly, with such an investment of time into gene therapy, is because I think that the safety bar for genomic medicine is very high. And this one has convinced me in terms of the potential,” Zaks said.  Another key feature for Zaks was that these treatments have the potential to be redosed, which sets Exsilio apart from other companies in the gene editing space that tout the one-and-done strategy. “One-and-done is really a bug, it’s not a feature,” Zaks said.  Genomic medicines split into two camps, Zaks explained. Gene editors typically encode the payload in an mRNA but can only correct very small sections of DNA at a time. If they are one-and-done, that limits what can be corrected. Traditional gene editing therapies use viral vectors, which can be challenging because patients can have prior immunity. Gene editing medicines are also typically administered in one large dose, so any adverse events can be difficult to manage up front.  "If you can repeat dose and titrate, it means you don't have to give a whopping high dose the one time you administer the medicine," Zaks said. This is also coupled with the proven safety profile of mRNA lipid nanoparticle delivery. Exsilio’s tech also has the potential to provide an entire therapeutic gene, rather than just pieces or smaller portions. Exsilio has arrived at a pretty key moment in the history of genomic medicines. One is that mRNA is now a proven modality thanks to Moderna and Pfizer/BioNTech and further work to push the technology into cancer vaccines. There’s also been a burst of scientific ingenuity in genetics, which is being combined with modern protein engineering tools like machine learning, AI and sequencing. And finally, the developmental precedent for these treatments has been established, with the FDA issuing guidance on the regulatory framework. “If you take together these three elements, I think the timing is really good for us. I don't think you could have launched this company five years ago,” Zaks said.  Another helpful element is that CRISPR Therapeutics and Vertex Pharmaceuticals just got a gene therapy approved in Casgevy for sickle cell disease, followed by others. CRISPR is an investor in Exsilio’s series A, which was co-led by Novartis Venture Fund and Delos Capital. Other investors include OrbiMed, Insight Partners, J.P. Morgan Life Sciences Private Capital, Innovation Endeavors, Invus, Arc Ventures and Deep Insight. Zaks could not disclose what disease areas Exsilio will explore initially, only that the targets are genetic diseases or rare diseases where the genetic defect is well understood, such as in cancer or autoimmune. The series A should support work through preclinical data collection. Zaks specifically was brought on to turn Exsilio into a development organization, he said.