The multi-center, double-blinded, randomized trial was designed to evaluate mucosal and serum immune responses following vaccination, as well as nasopharyngeal colonization after attenuated challenge. The trial enrolled 300 healthy volunteers ranging from 18 to 50 years old. Participants were randomized to receive either BPZE1 or BOOSTRIX® (tetanus toxoid, reduced diphtheria toxoid and acellular pertussis vaccine) and then challenged three months later with either BPZE1 or placebo and tested for nasal colonization.

The manuscript titled “Immunogenicity and safety of BPZE1, an intranasal live attenuated pertussis vaccine, versus tetanus–diphtheria– acellular pertussis vaccine: a randomised, double-blind, phase 2b trial” was published in The Lancet on March 10, 2023. The publication can be found here (link).

Key findings from the trial are summarized below:

• BPZE1 was well tolerated with most participants experiencing no or mild systemic, nasal or respiratory symptoms of short duration, similar to that observed with Boostrix and placebo, including no vaccine-related serious adverse events.
• A single vaccination with BPZE1 prevented colonization in 90% of participants after challenge 3 months later.
• BPZE1 was differentiated in its ability to induce broad mucosal immunity with sustained durability to the end of the study (9 months).
• Boostrix induced systemic immunity as expected, but was unable to substantially prevent colonizing infection or induce broad mucosal immunity as seen with BPZE1.

“In contrast to Boostrix, BPZE1 demonstrated both protection against attenuated Bordetella pertussis colonization and induction of pertussis-specific mucosal immune responses. In addition, BPZE1 demonstrated a favorable safety profile in this study. These data support the continued development of BPZE1,” said Stephanie Noviello M.D., ILiAD Chief Medical Officer.

Keith Rubin MD, ILiAD founder and CEO commented, “The publication of these data in The Lancet, one of the most respected peer-reviewed medical journals in the world, is consistent with the quality of our Phase 2b study and the potential major public health impact of BPZE1. These data add to the robust body of evidence supporting the potential of BPZE1 to address the limitations of current pertussis vaccines and to greatly reduce morbidity and mortality due to Bordetella pertussis on a global scale.”

BPZE1 was developed in the lab 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) and is designed to overcome deficiencies of current pertussis vaccines.

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, pertussis affects approximately 16 million people each year globally, accounting for nearly 200,000 deaths. There has been an overall increase in reported pertussis cases since the early 1980s. Pertussis is highly contagious, and an infected person can transmit B. pertussis to as many as 15 other people. Pertussis can lead to serious illness in people of all ages and can be life-threatening in young infants.

About BPZE1

BPZE1 is the only next generation live-attenuated intranasal pertussis vaccine in advanced clinical trials designed to protect against Bordetella pertussis nasal infection (colonization) and active disease through the induction of broad and sustained mucosal and systemic immunity. BPZE1 is currently being developed as a booster vaccine in children, adolescents and adults with future development investigating its application as a primary vaccination in infants.

About ILiAD Biotechnologies, LLC

ILiAD Biotechnologies is utilizing its B-Tech technology to develop next generation vaccines to prevent infectious diseases and improve lives. Its lead candidate, BPZE1, is the most advanced next generation vaccine for immunization against pertussis (whooping cough), a potentially lethal disease caused by Bordetella pertussis. For further information, please visit www.iliadbio.com or follow us on Twitter.

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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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