UK MHRA Grants Innovation Passport Designation to ILiAD Biotechnologies BPZE1 Next Generation Intranasal Pertussis Vaccine

ILiAD Biotechnologies (ILiAD), a clinical-stage biotech company dedicated to the prevention and treatment of human disease caused by Bordetella pertussis and other respiratory pathogens, today announced that the U.K. Medicines & Healthcare Products Regulatory Agency (MHRA) has granted Innovation Passport designation to BPZE1, the leading next generation intranasal pertussis vaccine. This innovative medicine designation has been awarded to BPZE1 indicated for active immunization against both upper respiratory tract B. pertussis colonization and symptomatic disease, more commonly known as whooping cough.

Having completed four Phase 2 clinical studies, BPZE1 is the most advanced pertussis vaccine currently in clinical development. Developed in the laboratory of Camille Locht, PhD, at the Institut Pasteur de Lille (IPL) and French National Institute of Health and Medical research (https://www.inserm.fr/en), BPZE1 is designed to overcome deficiencies of current pertussis vaccines, including poor durability of protection and failure to prevent nasopharyngeal B. pertussis colonization that leads to escape mutants and transmission to vulnerable infants.

BPZE1 has demonstrated positive Phase 2b results in both adults and school-age children. Most recently in May 2024, ILiAD announced topline data from the Phase 2b SUPER Trial (Standing Up to PERtussis) – the first BPZE1 study in school-age children. The SUPER trial demonstrated that BPZE1 induced broad mucosal and systemic immunological antibody responses in children that were higher than those previously reported for BPZE1 administered to adults. In addition, no interference was observed when BPZE1 was co-administered with tetanus, diphtheria, and acellular pertussis (Tdap, Boostrix®).

"The U.K. Innovation Passport designation is another important recognition of the promise of BPZE1 to address unmet medical needs not satisfied by current pertussis vaccines and further highlights the willingness of key regulatory authorities to support the accelerated development of BPZE1,” said Amy B. Fix, ILiAD’s Chief Regulatory Officer. “This designation, in addition to the previously awarded Fast Track designation by the U.S. FDA, offers ILiAD enhanced access to regulators, and the potential for reduced marketing application review timelines and rolling reviews, which could contribute to bringing BPZE1 to the UK and US markets as efficiently as possible.”

Rising rates of whooping cough have been recently reported across England. Almost 14,000 laboratory confirmed cases of whooping cough were reported to the UK Health Security Agency (UKHSA) between January and September 2024. Pertussis outbreaks have been reported globally over the past year, including a 10 year high in both the U.S. and Europe, underscoring the limitations of current pertussis vaccines and the need for more effective vaccines.

ILiAD is currently working with global regulators to finalize Phase 3 BPZE1 clinical trial protocols to support licensure, with a goal of initiating a pivotal study in 2025.

About Pertussis

Pertussis, also known as 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 adult and adolescent nasal passages, to protect adults and adolescents 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 adolescents and to indirectly protect vulnerable infants, future development aims to immunize neonates directly.

About the Innovation Passport

The Innovation Passport Designation by the U.K. MHRA is designed to facilitate the development and expedite the review of investigational products to treat serious conditions and fill an unmet medical need, with the intent of getting important new products to the population in an expedited manner. The Innovation Passport Designation is the entry point to the Innovative Licensing and Access Pathway (ILAP) which aims to accelerate time to market, facilitating patient access.

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.

“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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