ILiAD Biotechnologies Expands BPZE1 Public Health and Commercial Potential with Publication of Pediatric Phase 2b Study in The Lancet Infectious Diseases

Intranasal pertussis vaccine candidate BPZE1 demonstrates robust nasal mucosal and systemic immune responses with a favorable safety profile in children ages 6 through 17 yearsFirst pediatric clinical trial builds on 5 prior adult BPZE1 clinical studiesDemonstrates safety and immunogenicity of BPZE1 in acellular pertussis vaccine primed individualsNo interference observed when BPZE1 co-administered with diphtheria and tetanus antigens

ILiAD Biotechnologies, Inc. (ILiAD), an advanced clinical stage biotech company focused on the prevention and treatment of disease caused by Bordetella pertussis, today announced the publication of results from its Phase 2b SUPER (Stand Up to Pertussis) clinical trial in The Lancet Infectious Diseases. This randomized, double blind, placebo- and active-comparator-controlled trial demonstrated that BPZE1, a live attenuated intranasal pertussis vaccine, induced robust nasal mucosal immune responses in healthy children aged 6 through 17 years (LINK). The study demonstrated that a single intranasal dose of BPZE1 induced nasal mucosal immune responses against all Bordetella pertussis antigens tested and was well tolerated, both when administered alone and when co-administered with a tetanus-diphtheria-acellular pertussis (Tdap) booster vaccine.

The multi-center Phase 2b trial enrolled 366 participants across 16 sites in the United Kingdom, Australia, and Costa Rica and included participants who had received acellular pertussis-containing vaccines in infancy. The study met its primary immunogenicity endpoint, demonstrating significant induction of pertussis-specific nasal secretory IgA (S-IgA), a key component of mucosal immunity that may help prevent infection and transmission. BPZE1 also met its key secondary objective by demonstrating no interference with systemic immune responses induced by co-administered Tdap vaccination.

Saul Faust, MBBS, PhD, Coordinating Investigator of the SUPER study, Professor of Pediatric Immunology and Infectious Diseases at the University of Southampton and Director of the National Institute for Health and Care Research (NIHR) Clinical Research Facility: Southampton, stated, "Despite widespread vaccination, pertussis continues to circulate globally," adding, "The robust BPZE1-induced nasal mucosal immune responses, non-interference with a current acellular pertussis vaccine, and favorable safety profile observed in this study further support the continued development of BPZE1 as a novel intranasal vaccine with the potential to address the shortcomings of current pertussis prevention."

Stephanie Noviello, MD, Chief Medical Officer of ILiAD Biotechnologies said, "The publication of the SUPER study results marks an important step in expanding our understanding of BPZE1's potential in children and adolescents who previously received the acellular pertussis vaccine series, a population that continues to play an important role in pertussis transmission.” Dr. Noviello further emphasized, "We are deeply grateful to the children who participated in the study, their families and caregivers, and the investigators, study coordinators, and site personnel whose commitment made this research possible."

BPZE1 demonstrated a favorable safety profile including minimal reactogenicity within the first 7 days after vaccination, with no vaccine-related serious adverse events, deaths, or discontinuations reported. Most adverse events were mild to moderate in severity. The authors concluded that the findings support continued development of BPZE1 as a next-generation vaccine candidate with the potential to not only prevent pertussis disease, but to also halt Bordetella pertussis infection and transmission in both children and adults.

About BPZE1

BPZE1 is a next-generation live-attenuated intranasal 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 school-age children’s nasal passages, to protect 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 school-age 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 and Nathalie Mielcarek.

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 more than 150,000 deaths. Although estimated global vaccination coverage is 84%, current vaccines have failed to control epidemics. In addition, current vaccines do not fully protect infants under age 6 months, since primary immunization requires multiple injections, usually at 2, 4 and 6 months of age.

About ILiAD Biotechnologies

ILiAD Biotechnologies (http://www.iliadbio.com) is a privately held, advanced clinical stage biotechnology company dedicated to the prevention and treatment of human disease caused by Bordetella pertussis. The company is developing and exploring 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 NIHR facilities in Southampton

The NIHR Clinical Research Facility: Southampton and NIHR Biomedical Research Centre: Southampton support the development and testing of new approaches to preventing, diagnosing and treating disease, helping innovative discoveries move more quickly into patient care. Together, they bring researchers, healthcare professionals, industry partners and patients together to deliver experimental medicine research and early-phase clinical studies. Both are partnerships between University Hospital Southampton NHS Foundation Trust and the University of Southampton, funded by the National Institute for Health and Care Research (NIHR).

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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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