Trial anticipated for H2 2025 to evaluate most advanced next generation intranasal pertussis vaccine for whooping cough
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. 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 B. pertussis outbreaks, which are currently widespread in the US and globally.
"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 B. pertussis
hVIVO and ILiAD are working to finalize the definitive agreement as ILiAD actively advances its financing initiatives to support the collaboration.
Enrollment is targeted to begin H2 2025 pending financing.
About ILiAD Biotechnologies, LLC
ILiAD Biotechnologies (http://www.iliadbio.com) is a privately held, clinical stage biotechnology company dedicated to the prevention and treatment of human disease caused by Bordetella pertussis. The company is developing and acquiring key technologies, working with leading scientists to overcome the limitations of current vaccines, investigating the impact of B. pertussis in a range of human disease, and is focused on validating its proprietary vaccines in human clinical trials.
About hVIVO
hVIVO plc (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.
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 Venn Life Sciences brand, and a lab offering via its 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.
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 FluCamp volunteer screening facilities in London and Manchester.
About Pertussis
Pertussis (whooping cough) is a life-threatening disease caused by the highly contagious respiratory bacterium Bordetella pertussis. 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.
About BPZE1
BPZE1 is a next-generation live-attenuated pertussis vaccine designed to induce comprehensive and durable protection against B. pertussis infection (colonization) and disease (whooping cough). BPZE1 is being developed to block B. pertussis 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. BPZE1 was developed at the Institut Pasteur de Lille (France) in the lab of Camille Locht PhD and Nathalie Mielcarek PhD.
"Safe Harbor" Statement under the Private Securities Litigation Reform Act of 1995.
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. 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. 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.
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Contacts:
Investors
Bill Steinkrauss
CFO
ILiAD Biotechnologies, LLC
info@iliadbiotech.com
800.603.3525
Media
Karen Sharma
CG Life
ksharma@cglife.com
