产品详细
The Problem 问题
The World Health Organisation (WHO) lists Hepatitis, Zika and COVID-19 among its priority diseases caused by viral pathogens. While we are still in the midst of the COVID pandemic, there is a real possibility that another serious international epidemic could arise from a pathogen currently unknown to cause human disease. Each of these disease threats display varying rates of incidence, morbidity and mortality, but are common in the sense that they degrade the individual’s quality of life, overburden health systems and as we have seen with the novel Coronavirus, can cripple economies. 世界卫生组织 (WHO) 将肝炎、寨卡病毒和 COVID-19 列为由病毒病原体引起的优先疾病。虽然我们仍处于COVID 疫情之中，但确实有可能出现另一场严重的国际流行病，这种流行病是由目前未知的可引起人类疾病的病原体引起的。这些疾病威胁中的每一种都显示出不同的发病率、发病率和死亡率，这些病毒会降低个人的生活质量，会使医疗系统负担过重，并且正如我们在新型冠状病毒中所看到的那样，会削弱经济。
We have identified four vaccines for the product development pipeline 我们已经为产品开发管道确定了四种疫苗:
• COVID-19: the COVID-19 pandemic has made the development of a safe, efficacious vaccine a global health priority. Infection results in a spectrum of disease ranging from asymptomatic infection to severe acute respiratory disease, pneumonia and death. New cases of COVID-19 exceed 227M worldwide, and the death toll has surpassed 4.6M. Recent complications with front-running vaccine candidates, especially in treating new variants has left the race open for a safe and effective solution to broadly immunise the population. COVID-19 疫情把开发安全、有效的疫苗成为全球卫生优先事项。感染 COVID-19 会导致一系列疾病，从无症状感染到严重的急性呼吸道疾病、肺炎和死亡。全球新的 COVID-19 病例超过 2.27 亿，死亡人数已超过 460 万。领先的候选疫苗最近出现的并发症，尤其是在
治疗新变种方面，使得人们在寻找一种安全有效的解决方案来广泛免疫人群方面展开竞争。
• Hepatitis C is a liver disease caused by the Hepatitis C virus, which manifests as a chronic illness in around 70% of people infected. Persistent HCV infection can result in serious liver disease, including cirrhosis and hepatocellular carcinoma. There is currently no effective vaccine against Hepatitis C and owing to the high cost ($80K/patient) access to anti-viral treatment is limited. 丙型肝炎是一种由丙型肝炎病毒引起的肝脏疾病，在大约 70% 的感染者中表现为慢性疾病。持续的 HCV 感染可导致严重的肝脏疾病，包括肝硬化和肝细胞癌。目前没有针对丙型肝炎的有效疫苗，而且由于成本高（每名患者 8 万元），获得抗病毒治疗的机会有限
• Zika virus, while often asymptomatic in the host, causes microcephaly and severe birth defects in infants born to infected mothers. The Zika wave was first reported in Brazil in 2015, and to date around 90 countries have reported evidence of mosquito-transmitted Zika infection1. There is currently no effective vaccine against ZIKV. • 寨卡病毒虽然在宿主中通常无症状，但会导致受感染母亲所生婴儿出现小头畸形和严重出生缺陷。寨卡病毒于 2015 年在巴西首次报道，迄今为止，约有 90 个国家报告了蚊子传播寨卡病毒感染的证据。目前还没有针对 ZIKV 的有效疫苗。
• Pan-Flavivirus is a genus of viruses including: Zika, Dengue virus, Japanese Encephalitis and Yellow Fever. Vaccine strategies to protect against these Flaviviruses are based largely on inactivated or attenuated virus, and are limited in their broader approval and rollout due to limited immunogenicity and enhanced risk of severe disease or adverse symptoms. 泛黄病毒属病毒属，包括：寨卡病毒、登革热病毒、日本脑炎和黄热病。预防这些黄病毒的疫苗
策略主要基于灭活或减毒的病毒，并且由于免疫原性有限和严重疾病或不良症状的风险增加而在更广泛的批准和推出方面受到限制
Competitive Advantage 竞争优势
Our vaccine platform utilises ‘nucleic acid’ based DNA constructs. In this approach, the individual’s immune system is activated in response to delivery of viral fragments encoded by a FDA approved plasmid DNA – pVAX1. The DNA vaccine is delivered intradermally into the individual, where the cellular machinery takes over and expresses an inert viral fragment to which the protective immune response is desired. Non-infectious Zika and COVID-19 viral antigens have been integrated into this plasmid, engineered and tested for efficacy. 我们的疫苗平台利用基于“核酸”的 DNA 构建体。在这种方法中，个体的免疫系统被激活以响应由 FDA 批准的质粒 DNA – pVAX1 编码的病毒片段的递送。 DNA 疫苗被皮内递送到个体中，在那里细胞机器接管并表达需要保护性免疫反应的惰性病毒片段。非传染性寨卡病毒和
COVID-19 病毒抗原已被整合到该质粒中，经过改造并测试其功效
We also have a Cytolytic DNA vaccine platform to target persistent viral infections such as HIV, Hepatitis C and Influenza. This Cytolytic DNA vaccine platform mimics the effect of live attenuated viral vaccines and generates high levels of cellular immunity. 我们还有一个细胞溶解 DNA 疫苗平台，以针对持续性病毒感染，如 HIV、丙型肝炎和流感。这种细胞溶解 DNA 疫苗平台模拟减毒活病毒疫苗的作用，并产生高水平的细胞免疫
The vaccines under construction range from TRL 3-4. The primary goal of vaccine development programs currently active under secured grant schemes (MTP BTB grant; NFMRI) is to complete the preclinical testing, and to provide efficacy and safety data needed to prepare for Phase I clinical trials 正在建设的疫苗范围为 TRL 3-4。目前在安全资助计划（MTP BTB 资助；NFMRI）下活跃的疫苗开发计划的主要目标是完成临床前测试，并提供准备 I 期临床试验所需的有效性和安全性数据
Our competitive advantage is 我们的竞争优势:
• Long lasting level of protection against infection due to vaccine inducing both a strong cellular (T cell) and antibody response 由于疫苗可诱导强烈的细胞（T 细胞）和抗体反应，因此可针对感染提供持久的保护水平.
• Excellent safety profile 出色的安全性
• Meets WHO Target Product Profile 符合 WHO 目标产品简介
No risk of Antibody Dependent Enhancement 没有抗体依赖性增强的风险
• Low reactogenicity (candidate for pregnant women)低反应原性（舍和孕妇）
• No vector immunity: prime – boost 无病媒免疫：
prime – boost
• Delivery via intradermal needle 通过皮内针递送
• No need for adjuvant 无需佐剂
• Stable for transportation and storage 运输和储存稳定
Easy manufacturing process compared to traditional protein or live-attenuated vaccines.与传统蛋白质或减毒活疫苗相比，制造过程简单。
The World Health Organisation (WHO) lists Hepatitis, Zika and COVID-19 among its priority diseases caused by viral pathogens. While we are still in the midst of the COVID pandemic, there is a real possibility that another serious international epidemic could arise from a pathogen currently unknown to cause human disease. Each of these disease threats display varying rates of incidence, morbidity and mortality, but are common in the sense that they degrade the individual’s quality of life, overburden health systems and as we have seen with the novel Coronavirus, can cripple economies. 世界卫生组织 (WHO) 将肝炎、寨卡病毒和 COVID-19 列为由病毒病原体引起的优先疾病。虽然我们仍处于COVID 疫情之中，但确实有可能出现另一场严重的国际流行病，这种流行病是由目前未知的可引起人类疾病的病原体引起的。这些疾病威胁中的每一种都显示出不同的发病率、发病率和死亡率，这些病毒会降低个人的生活质量，会使医疗系统负担过重，并且正如我们在新型冠状病毒中所看到的那样，会削弱经济。
We have identified four vaccines for the product development pipeline 我们已经为产品开发管道确定了四种疫苗:
• COVID-19: the COVID-19 pandemic has made the development of a safe, efficacious vaccine a global health priority. Infection results in a spectrum of disease ranging from asymptomatic infection to severe acute respiratory disease, pneumonia and death. New cases of COVID-19 exceed 227M worldwide, and the death toll has surpassed 4.6M. Recent complications with front-running vaccine candidates, especially in treating new variants has left the race open for a safe and effective solution to broadly immunise the population. COVID-19 疫情把开发安全、有效的疫苗成为全球卫生优先事项。感染 COVID-19 会导致一系列疾病，从无症状感染到严重的急性呼吸道疾病、肺炎和死亡。全球新的 COVID-19 病例超过 2.27 亿，死亡人数已超过 460 万。领先的候选疫苗最近出现的并发症，尤其是在
治疗新变种方面，使得人们在寻找一种安全有效的解决方案来广泛免疫人群方面展开竞争。
• Hepatitis C is a liver disease caused by the Hepatitis C virus, which manifests as a chronic illness in around 70% of people infected. Persistent HCV infection can result in serious liver disease, including cirrhosis and hepatocellular carcinoma. There is currently no effective vaccine against Hepatitis C and owing to the high cost ($80K/patient) access to anti-viral treatment is limited. 丙型肝炎是一种由丙型肝炎病毒引起的肝脏疾病，在大约 70% 的感染者中表现为慢性疾病。持续的 HCV 感染可导致严重的肝脏疾病，包括肝硬化和肝细胞癌。目前没有针对丙型肝炎的有效疫苗，而且由于成本高（每名患者 8 万元），获得抗病毒治疗的机会有限
• Zika virus, while often asymptomatic in the host, causes microcephaly and severe birth defects in infants born to infected mothers. The Zika wave was first reported in Brazil in 2015, and to date around 90 countries have reported evidence of mosquito-transmitted Zika infection1. There is currently no effective vaccine against ZIKV. • 寨卡病毒虽然在宿主中通常无症状，但会导致受感染母亲所生婴儿出现小头畸形和严重出生缺陷。寨卡病毒于 2015 年在巴西首次报道，迄今为止，约有 90 个国家报告了蚊子传播寨卡病毒感染的证据。目前还没有针对 ZIKV 的有效疫苗。
• Pan-Flavivirus is a genus of viruses including: Zika, Dengue virus, Japanese Encephalitis and Yellow Fever. Vaccine strategies to protect against these Flaviviruses are based largely on inactivated or attenuated virus, and are limited in their broader approval and rollout due to limited immunogenicity and enhanced risk of severe disease or adverse symptoms. 泛黄病毒属病毒属，包括：寨卡病毒、登革热病毒、日本脑炎和黄热病。预防这些黄病毒的疫苗
策略主要基于灭活或减毒的病毒，并且由于免疫原性有限和严重疾病或不良症状的风险增加而在更广泛的批准和推出方面受到限制
Competitive Advantage 竞争优势
Our vaccine platform utilises ‘nucleic acid’ based DNA constructs. In this approach, the individual’s immune system is activated in response to delivery of viral fragments encoded by a FDA approved plasmid DNA – pVAX1. The DNA vaccine is delivered intradermally into the individual, where the cellular machinery takes over and expresses an inert viral fragment to which the protective immune response is desired. Non-infectious Zika and COVID-19 viral antigens have been integrated into this plasmid, engineered and tested for efficacy. 我们的疫苗平台利用基于“核酸”的 DNA 构建体。在这种方法中，个体的免疫系统被激活以响应由 FDA 批准的质粒 DNA – pVAX1 编码的病毒片段的递送。 DNA 疫苗被皮内递送到个体中，在那里细胞机器接管并表达需要保护性免疫反应的惰性病毒片段。非传染性寨卡病毒和
COVID-19 病毒抗原已被整合到该质粒中，经过改造并测试其功效
We also have a Cytolytic DNA vaccine platform to target persistent viral infections such as HIV, Hepatitis C and Influenza. This Cytolytic DNA vaccine platform mimics the effect of live attenuated viral vaccines and generates high levels of cellular immunity. 我们还有一个细胞溶解 DNA 疫苗平台，以针对持续性病毒感染，如 HIV、丙型肝炎和流感。这种细胞溶解 DNA 疫苗平台模拟减毒活病毒疫苗的作用，并产生高水平的细胞免疫
The vaccines under construction range from TRL 3-4. The primary goal of vaccine development programs currently active under secured grant schemes (MTP BTB grant; NFMRI) is to complete the preclinical testing, and to provide efficacy and safety data needed to prepare for Phase I clinical trials 正在建设的疫苗范围为 TRL 3-4。目前在安全资助计划（MTP BTB 资助；NFMRI）下活跃的疫苗开发计划的主要目标是完成临床前测试，并提供准备 I 期临床试验所需的有效性和安全性数据
Our competitive advantage is 我们的竞争优势:
• Long lasting level of protection against infection due to vaccine inducing both a strong cellular (T cell) and antibody response 由于疫苗可诱导强烈的细胞（T 细胞）和抗体反应，因此可针对感染提供持久的保护水平.
• Excellent safety profile 出色的安全性
• Meets WHO Target Product Profile 符合 WHO 目标产品简介
No risk of Antibody Dependent Enhancement 没有抗体依赖性增强的风险
• Low reactogenicity (candidate for pregnant women)低反应原性（舍和孕妇）
• No vector immunity: prime – boost 无病媒免疫：
prime – boost
• Delivery via intradermal needle 通过皮内针递送
• No need for adjuvant 无需佐剂
• Stable for transportation and storage 运输和储存稳定
Easy manufacturing process compared to traditional protein or live-attenuated vaccines.与传统蛋白质或减毒活疫苗相比，制造过程简单。