SCHLIEREN, Switzerland--(BUSINESS WIRE)--LimmaTech Biologics AG announced positive interim data from its Phase I/II clinical trial evaluating Shigella4V (S4V), a tetravalent bioconjugate vaccine candidate against shigellosis, an infectious disease caused by Shigella bacteria. Shigellosis is a serious infection and remains the second leading cause of fatal diarrheal disease, particularly in infants in low- and middle-income countries.

瑞士纹影公司——（商业新闻短讯）——LimmaTech Biologics AG宣布了其I/II期临床试验的阳性中期数据，该试验评估了志贺氏菌4V（S4V），这是一种四价生物结合疫苗候选物，用于治疗志贺氏菌病，一种由志贺氏菌引起的传染病。志贺氏菌病是一种严重感染，仍然是致命性腹泻病的第二大原因，尤其是中低收入国家的婴儿。

In the nine-month-old target population, administration of S4V demonstrated a favorable safety and tolerability profile as well as robust data on immunogenicity against the four most common pathogenic Shigella serotypes, S. flexneri 2a, 3a, 6, and S. sonnei. Topline data from the now completed Phase I/II trial, conducted in Kenya, are expected in the first half of 2024..

在9个月大的目标人群中，S4V的给药表现出良好的安全性和耐受性，以及针对四种最常见的致病性志贺菌血清型福氏2a，3a，6和宋内志贺菌的免疫原性的可靠数据。在肯尼亚进行的现已完成的I/II期试验的Topline数据预计将于2024年上半年提供。。

LimmaTech’s S4V vaccine candidate demonstrated initial safety in all age groups evaluated already in the first part of the clinical trial. The current data update from the second part of the clinical trial includes 472 infants (nine months ± one month) who received two intramuscular injections at one of four different dose levels with or without the addition of an adjuvant.

LimmaTech的S4V候选疫苗在临床试验的第一部分已经评估了所有年龄组的初始安全性。临床试验第二部分的最新数据包括472名婴儿（9个月±1个月），他们在添加或不添加佐剂的情况下，以四种不同剂量水平之一接受了两次肌内注射。

S4V was well tolerated with the majority of local and systemic reactions reported being mild in intensity and similarly distributed between the different groups. No vaccine-related serious adverse events (SAEs) were reported. A statistically significant increase in serum IgG levels was obtained after either the first or the second injection, depending on the dose and formulation used..

S4V耐受性良好，据报道大多数局部和全身反应强度较轻，并且在不同组之间分布相似。没有报告疫苗相关的严重不良事件（SAE）。根据使用的剂量和制剂，在第一次或第二次注射后，血清IgG水平在统计学上显着增加。。

“These positive interim results with S4V establish the very good immunogenicity that our bioconjugate vaccine candidate can generate in nine-month-old infants, a population that needs it the most,” commented Patricia Martin, PhD, Chief Operating Officer of LimmaTech. “Shigellosis is a serious disease caused by a pathogen continuously evolving and becoming increasingly resistant to antibiotics.

LimmaTech首席运营官Patricia Martin博士评论道：“S4V的这些阳性中期结果确立了我们的生物结合疫苗候选物可以在9个月大的婴儿中产生非常好的免疫原性，而这些婴儿是最需要它的人群。”。“志贺氏菌病是一种严重的疾病，由病原体不断进化并对抗生素产生越来越大的耐药性引起。

Our vaccine candidate has the potential to prevent an infection that threatens the lives of many children as well as protect travelers and military personnel traveling to Shigella-endemic countries. We look forward to continuing its clinical development in a study we plan to initiate in 2024.”.

我们的候选疫苗有可能预防威胁许多儿童生命的感染，并保护前往志贺菌流行国家的旅行者和军人。我们期待着在2024年开始的一项研究中继续其临床开发。”。

The interim Phase I/II data were previously presented at the BactiVac 4th Annual Network Meeting 2023 held in Birmingham, UK.

先前在英国伯明翰举行的2023年BactiVac第四届年度网络会议上介绍了I/II期中期数据。

About the Phase I/II study

关于I/II期研究

Conducted in Kenya, the Phase I/II study is a randomized, double-blind, dose-finding, and age-descending clinical trial designed to assess the safety and immunogenicity of Shigella4V (S4V). The clinical trial is divided into two parts. The Part 1 age-descending study evaluated the vaccine candidate’s safety in adults, children (two-five years), and infants.

在肯尼亚进行的I/II期研究是一项随机，双盲，剂量发现和年龄下降的临床试验，旨在评估志贺菌4V（S4V）的安全性和免疫原性。临床试验分为两部分。第一部分年龄下降研究评估了候选疫苗在成人，儿童（2-5岁）和婴儿中的安全性。

The Part 2 dose-finding study evaluates S4V’s safety and immunogenicity in the nine-month-old target population to identify the preferred vaccine dose..

第二部分剂量发现研究评估了S4V在9个月大的目标人群中的安全性和免疫原性，以确定首选的疫苗剂量。。

In 2015, LimmaTech signed a research collaboration agreement with GlaxoSmithKline (GSK) to develop novel, bioconjugate antigen-based vaccines, including a monovalent Shigella vaccine to be developed with the support of the Wellcome Trust. Following positive results from the proof-of-concept clinical trial with the monovalent Shigella vaccine, LimmaTech and GSK initiated the development of a multivalent Shigella vaccine funded in part by a Wellcome Trust grant.

2015年，LimmaTech与葛兰素史克（GlaxoSmithKline，GSK）签署了一项研究合作协议，以开发新型的生物结合抗原疫苗，包括在惠康基金会的支持下开发的单价志贺氏菌疫苗。在单价志贺菌疫苗概念验证临床试验取得积极结果后，LimmaTech和GSK启动了多价志贺菌疫苗的开发，部分资金来自惠康信托基金。

In July 2023, LimmaTech announced that it had in-licensed the S4V Shigella bioconjugate vaccine candidate from GSK to lead the further development of the program..

2023年7月，LimmaTech宣布已从GSK获得S4V志贺氏菌生物结合疫苗候选物的许可，以领导该计划的进一步发展。。

About Shigellosis:

关于志贺氏菌病：

Shigellosis is a global health threat caused by the Gram-negative Shigella spp. bacteria. It is estimated that about 188 million infections are due to Shigella of which 62.3 million cases occur in children younger than 5 years. Diarrheal infection is one of the major causes of morbidity and mortality in numerous countries as well as in travelers and deployed military personnel in endemic regions.

志贺菌病是由革兰氏阴性志贺菌属细菌引起的全球健康威胁。据估计，约有1.88亿人感染志贺菌，其中6230万例发生在5岁以下的儿童中。腹泻感染是许多国家以及流行地区旅行者和部署军事人员发病率和死亡率的主要原因之一。

There are 600,000 deaths attributed to Shigella each year and it is the second leading cause for diarrheal deaths. The standard treatment for shigellosis is oral rehydration and antibiotic therapy, however, the bacteria have acquired resistance to many antibiotics with numerous reports of outbreaks of multidrug-resistant strains, making treatment extremely difficult.

每年有60万人死于志贺菌，它是腹泻死亡的第二大原因。志贺菌病的标准治疗方法是口服补液和抗生素治疗，然而，细菌对许多抗生素产生了耐药性，许多报道称多重耐药菌株爆发，这使得治疗极其困难。

Currently, no licensed Shigella vaccine is available..

目前，没有获得许可的志贺菌疫苗。。

About LimmaTech Biologics

关于LimmaTech Biologics

LimmaTech Biologics is at the forefront of combating the global antimicrobial resistance epidemic based on its unparalleled track record in vaccine technology and clinical candidate development. The company is leveraging its proprietary self-adjuvanting and multi-antigen vaccine platform alongside additional disease-specific vaccine approaches to prevent increasingly untreatable microbial infections.

基于其在疫苗技术和临床候选药物开发方面无与伦比的记录，LimmaTech Biologics处于抗击全球抗菌素耐药性流行病的前沿。该公司正在利用其专有的自我佐剂和多抗原疫苗平台以及其他疾病特异性疫苗方法来预防越来越无法治疗的微生物感染。

With decades of expertise and an expanding, robust pipeline, the LimmaTech team is dedicated to generating protective solutions to deliver transformative value worldwide. For more information, please visit www.lmtbio.com..

凭借数十年的专业知识和不断扩大的强大渠道，LimmaTech团队致力于产生保护性解决方案，以在全球范围内提供变革性价值。有关更多信息，请访问www.lmtbio.com。。