WESTON, Fla.--(

佛罗里达州韦斯顿--(

BUSINESS WIRE

商业热线

)--ILiAD Biotechnologies, LLC, a biotech company developing BPZE1, the most advanced next generation intranasal pertussis vaccine to protect against whooping cough, today announced that following a December 2024 Type C meeting with the United States Food and Drug Administration (FDA), ILiAD and hVIVO plc (hVIVO) have signed a Letter of Intent (LOI) to conduct a pivotal Phase 3 BPZE1 human challenge trial.

)--ILiAD Biotechnologies，LLC是一家开发BPZE1的生物技术公司，BPZE1是最先进的下一代鼻内百日咳疫苗，可预防百日咳，今天宣布，在2024年12月与美国食品和药物管理局（FDA）举行C型会议后，ILiAD和hVIVO plc（hVIVO）签署了一份意向书（LOI），以进行关键的3期BPZE1人类挑战试验。

hVIVO is a specialist contract research organization (CRO) and a world leader in human challenge models. A human challenge trial overcomes the complexities associated with conducting traditional Phase 3 field studies, which is particularly relevant for pertussis due to the unpredictability of .

hVIVO是一家专业合同研究组织（CRO），也是人类挑战模型领域的世界领导者。人体挑战试验克服了与进行传统的3期现场研究相关的复杂性，由于百日咳的不可预测性，这与百日咳特别相关。

B. pertussis

百日咳鲍特菌

outbreaks, which are currently widespread in the US and globally.

疫情目前在美国和全球范围内普遍存在。

“We welcome the opportunity to partner with hVIVO, a CRO with extensive experience in human challenge studies, particularly those evaluating vaccines and medicines against infectious respiratory pathogens,' said Keith Rubin, M.D., Chief Executive Officer and Founder of ILiAD. Dr. Rubin added “We look forward to working with hVIVO to conduct this critical next phase in the development of BPZE1 and to achieve our mission to deliver BPZE1 to US and global markets and ultimately bring an end to disease due to .

ILiAD首席执行官兼创始人、医学博士基思·鲁宾（KeithRubin）说：“我们欢迎有机会与hVIVO合作，hVIVO是一家在人类挑战研究方面拥有丰富经验的首席风险官，尤其是那些评估针对传染性呼吸道病原体的疫苗和药物的研究。”鲁宾博士补充说：“我们期待着与hVIVO合作，开展BPZE1开发的这一关键的下一阶段，并实现我们的使命，将BPZE1交付给美国和全球市场，最终结束因以下原因引起的疾病。”。

B. pertussis

百日咳鲍特菌

.”

.”

hVIVO and ILiAD are working to finalize the definitive agreement as ILiAD actively advances its financing initiatives to support the collaboration.

hVIVO和ILiAD正在努力敲定最终协议，因为ILiAD积极推进其融资举措，以支持合作。

Enrollment is targeted to begin H2 2025 pending financing.

。

About ILiAD Biotechnologies, LLC

关于ILiAD Biotechnologies，LLC

ILiAD Biotechnologies (

伊利亚特生物技术(

http://www.iliadbio.com

http://www.iliadbio.com

) is a privately held, clinical stage biotechnology company dedicated to the prevention and treatment of human disease caused by

)是一家私营的临床阶段生物技术公司，致力于预防和治疗由

Bordetella pertussis

百日咳博德特菌

. The company is developing and acquiring key technologies, working with leading scientists to overcome the limitations of current vaccines, investigating the impact of

该公司正在开发和获取关键技术，与领先的科学家合作克服当前疫苗的局限性，调查

B. pertussis

百日咳鲍特菌

in a range of human disease, and is focused on validating its proprietary vaccines in human clinical trials.

在一系列人类疾病中，并专注于在人体临床试验中验证其专有疫苗。

About hVIVO

关于HVIVO

hVIVO plc

hVIVO有限公司

(ticker: HVO) is a fast-growing specialist contract research organisation (CRO) and the world leader in testing infectious and respiratory disease vaccines and therapeutics using human challenge clinical trials. The Group provides end-to-end early clinical development services to its large, established and growing repeat client base, which includes four of the top 10 largest global biopharma companies..

（股票代码：HVO）是一家快速发展的专业合同研究组织（CRO），是使用人类挑战临床试验测试传染病和呼吸道疾病疫苗和治疗方法的世界领导者。该集团为其庞大、成熟且不断增长的重复客户群提供端到端的早期临床开发服务，其中包括全球10大生物制药公司中的四家。。

The Group's fast-growing services business includes a unique portfolio of 11 human challenge models, with a number of new models under development, to test a broad range of infectious and respiratory disease products. The Group has world class challenge agent manufacturing capabilities, specialist drug development and clinical consultancy services via its .

该集团快速增长的服务业务包括11种人类挑战模型的独特组合，以及许多正在开发的新模型，以测试广泛的传染病和呼吸道疾病产品。该集团通过its拥有世界一流的挑战药物制造能力、专业药物开发和临床咨询服务。

Venn Life Sciences

朋友生命科学

brand, and a lab offering via its

品牌，以及通过its提供的实验室产品

hLAB

hLAB

brand, which includes virology, immunology biomarker and molecular testing. The Group also offers additional clinical field trial services such as patient recruitment and clinical trial site services.

品牌，包括病毒学，免疫学生物标志物和分子检测。该集团还提供额外的临床现场试验服务，如患者招募和临床试验现场服务。

hVIVO runs challenge trials in London - its new state-of-the-art facilities in Canary Wharf opened in 2024 and is the world's largest commercial human challenge trial unit, with highly specialised on-site virology and immunology laboratories, and an outpatient unit. To recruit volunteers / patients for its studies, the Group leverages its unique clinical trial recruitment capability via its .

hVIVO在伦敦进行挑战试验-其位于金丝雀码头的最新设施于2024年开放，是世界上最大的商业人类挑战试验单位，拥有高度专业化的现场病毒学和免疫学实验室以及一个门诊单位。为了招募志愿者/患者进行研究，该集团通过its利用其独特的临床试验招募能力。

FluCamp

FluCamp

volunteer screening facilities in London and Manchester.

伦敦和曼彻斯特的志愿者筛选设施。

About Pertussis

Pertussis (whooping cough) is a life-threatening disease caused by the highly contagious respiratory bacterium

百日咳（百日咳）是一种威胁生命的疾病，由高度传染性的呼吸道细菌引起

Bordetella pertussis

百日咳博德特菌

. According to U.S. Centers for Disease Control and Prevention, each year pertussis affects approximately 16 million people globally, accounting for nearly 200,000 deaths. Although estimated global vaccination coverage is 84%, current vaccines have failed to control epidemics.

根据美国疾病控制和预防中心的数据，百日咳每年影响全球约1600万人，造成近20万人死亡。虽然估计全球疫苗接种覆盖率为84%，但目前的疫苗未能控制流行病。

About BPZE1

关于BPZE1

BPZE1 is a next-generation live-attenuated pertussis vaccine designed to induce comprehensive and durable protection against

BPZE1是下一代百日咳减毒活疫苗，旨在诱导对百日咳的全面持久保护

B. pertussis

百日咳鲍特菌

infection (colonization) and disease (whooping cough). BPZE1 is being developed to block

感染（定植）和疾病（百日咳）。正在开发BPZE1以阻止

B. pertussis

百日咳鲍特菌

from colonizing the nasal passages of adults and children, to protect adults and children from whooping cough, and to potentially prevent transmission, including transmission to infants. While ILiAD is currently focused on developing a vaccine to directly protect adults and children and to indirectly protect vulnerable infants, future development aims to immunize neonates directly.

防止成人和儿童的鼻腔定植，保护成人和儿童免受百日咳，并有可能防止传播，包括传播给婴儿。虽然ILiAD目前专注于开发一种疫苗，以直接保护成人和儿童，并间接保护易受伤害的婴儿，但未来的发展目标是直接为新生儿免疫。

BPZE1 was developed at the Institut Pasteur de Lille (France) in the lab of Camille Locht PhD and Nathalie Mielcarek PhD..

BPZE1是在卡米尔·洛赫特博士和纳塔莉·米尔卡雷克博士的实验室中由巴斯德·德·里尔研究所（法国）开发的。。

“Safe Harbor” Statement under the Private Securities Litigation Reform Act of 1995.

1995年《私人证券诉讼改革法案》下的“安全港”声明。

In addition to historical facts or statements of current, this press release may contain forward-looking statements. Forward-looking statements provide ILiAD’s current expectations or forecasts of future events. These may include statements regarding anticipated development of potential products, interpretation of clinical results, prospects for regulatory approval, outsourcing trends in the pharmaceutical industry, levels of industry research and development spending, rapid technological change, risks associated with acquisitions and investments, risks associated directly with BPZE technologies including but not limited to uncertainties of product development, and uncertainties of clinical development, dependence on third parties, competition, protection of patents and proprietary technology, potential for infringement and other statements regarding matters that are not historical fact.

除了历史事实或当前声明外，本新闻稿可能还包含前瞻性声明。前瞻性声明提供了ILiAD对未来事件的当前预期或预测。这些可能包括关于潜在产品的预期开发、临床结果的解释、监管批准的前景、制药行业的外包趋势、行业研发支出水平、快速技术变革、与收购和投资相关的风险、与BPZE技术直接相关的风险的声明，包括但不限于产品开发的不确定性、临床开发的不确定性、对第三方的依赖、竞争、专利和专有技术的保护、侵权的可能性以及其他关于非历史事实的声明。

Some of these forward-looking statements may be identified by use of words in the statements such as “estimate,” “intend,” or other words and terms of similar meaning. Statements in this release are not guarantees of future performance and involve certain risks, uncertainties and assumptions, which are difficult to predict.

这些前瞻性陈述中的一些可以通过在陈述中使用诸如“估计”、“打算”或其他具有类似含义的词语和术语来识别。本版本中的声明不保证未来的表现，并涉及某些难以预测的风险、不确定性和假设。

Therefore, actual outcomes and results may differ materially from what is expressed in such forward-looking statements. ILiAD cautions investors not to place reliance on the forward-looking statements contained in this press release. These statements speak only as of the date of this release and ILiAD undertakes no obligations to update or review these statements, except as may be required by law..

因此，实际结果和结果可能与此类前瞻性声明中表达的内容存在重大差异。伊利亚特提醒投资者不要依赖本新闻稿中的前瞻性声明。这些声明仅在发布之日有效，除法律要求外，ILiAD不承担更新或审查这些声明的义务。。