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ILiAD Biotechnologies Announces Lancet Microbe Publication of BPZE1 Phase 2b Clinical Results in Human Challenge Model

via Business Wire
  • Study Highlights First-ever Demonstration of Protection Against B. pertussis Colonization in Humans

ILiAD Biotechnologies, LLC (ILiAD), an advanced clinical stage biotech company focused on the prevention and treatment of disease caused by Bordetella Pertussis, today announced the peer-reviewed publication of Phase 2b trial results in The Lancet Microbe (Link). The published research article summarizes the CHAMPION-1 clinical study of BPZE1, a randomized, double-blind, placebo-controlled study conducted in healthy adults in a controlled human infection model. BPZE1 is the leading next generation pertussis vaccine designed to induce comprehensive immunity for the prevention of B. pertussis infection, disease and transmission.

In this study, BPZE1 administered as an intranasal spray met the primary endpoint of protection against nasopharyngeal B. pertussis colonization (p=0.033) in the pre-specified sensitivity analysis of participants challenged with adequate inoculum of wild-type B. pertussis. BPZE1 vaccination reduced the bacterial burden of virulent B. pertussis by more than 97% compared to placebo controls. Broad nasal mucosal and systemic immune responses and potent serum bactericidal activity were demonstrated among those vaccinated with BPZE1 in contrast to placebo-recipients. The safety profile of BPZE1 was favorable with no severe nasal, respiratory or systemic symptoms post-vaccination and no serious adverse events.

Principal investigator for the CHAMPION-1 study, Dr. Diane Gbesemete at the University of Southampton stated, “Despite relatively high vaccination rates, pertussis outbreaks observed worldwide in recent years highlight the deficiencies of current pertussis vaccines and the need for new and improved vaccines. This article is the first peer-reviewed published report of a new intranasal pertussis vaccine studied using the pertussis controlled human infection model (CHIM) developed at our institution for the PERISCOPE Consortium (Link). This study supports the clinical potential of BPZE1 and demonstrates the utility of CHIMs to progress vaccine development, especially in areas of unmet medical need.”

The CHAMPION-1 Phase 2b Human Challenge study had a primary objective to demonstrate that prior immunization with BPZE1 protects against colonization as evidenced by a negative B. pertussis culture following virulent B. pertussis challenge 2–4 months after vaccination. Additional objectives included demonstration of safety, nasal mucosal and serum immunological response, functional serum bactericidal activity, and reduction in overall bacterial load following virulent B. pertussis challenge. The study included vaccination of 53 participants at the National Institute for Health and Care Research (NIHR) Southampton Clinical Research Facility at University Hospital Southampton in partnership with the University of Southampton, and at the University of Oxford in the United Kingdom. 46 participants were inoculated in Southampton, with a targeted 105 CFU of virulent B. pertussis 2–4 months after vaccination, followed by a 16-night stay in a quarantined challenge facility where nasal mucosal and blood samples were collected. All study participants were treated with antibiotics before leaving quarantine.

Stephanie Noviello, MD, MPH, ILiAD Chief Medical Officer noted, “As detailed in The Lancet Microbe publication, a single intranasal administration of BPZE1 protected participants from virulent wild-type B. pertussis challenge with a favorable safety profile. These results highlight the differentiated mechanism of BPZE1, especially BPZE1’s unique ability to induce not only systemic immunity, but also nasopharyngeal mucosal immunity which is critical in the prevention of B. pertussis colonization. We look forward to continuing development of BPZE1 in Phase 3 studies, anticipated to begin next year.”

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. In addition, current vaccines do not fully protect infants under age 6 months, since immunization requires multiple injections, usually at 2, 4 and 6 months.

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

About ILiAD Biotechnologies, LLC

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 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 University Hospital Southampton

University Hospital Southampton NHS Foundation Trust (UHS) is one of the largest acute teaching trusts in England. UHS is consistently one of the UK's highest recruiting trusts of patients to clinical trials and in the top ten nationally for research study volume as ranked by the NIHR Clinical Research Network. In a strategic partnership with the University of Southampton, UHS has £35 million of NIHR infrastructure dedicated to bringing the latest treatments to patients.

About University of Southampton

The University of Southampton is among the top 100 institutions globally (QS World University Rankings 2026), driving original thinking, turning knowledge into action and impact, and creating solutions to the world’s challenges. Our academics are leaders in their fields, forging links with high-profile international businesses and organisations, and inspiring a 22,000-strong community of exceptional students, from over 135 countries worldwide. Through our high-quality education, we help students on a journey of discovery to realise their potential and join our global network of around 200,000 alumni. The University’s Southampton Controlled Human Infection Group developed the world’s first B. pertussis Controlled Human Infection Model (CHIM) with a view to guiding and novel B. pertussis vaccine design, and assessing the impact of vaccination on asymptomatic colonization with B. pertussis.

About University of Oxford

Oxford University has been placed number 1 in the Times Higher Education World University Rankings for the seventh year running, and number 2 in the QS World Rankings 2022. At the heart of this success are the twin- pillars of our ground-breaking research and innovation and our distinctive educational offer. Oxford is world-famous for research and teaching excellence and home to some of the most talented people from across the globe. Our work helps the lives of millions, solving real-world problems through a huge network of partnerships and collaborations. The breadth and interdisciplinary nature of our research alongside our personalised approach to teaching sparks imaginative and inventive insights and solutions. Through its research commercialisation arm, Oxford University Innovation, Oxford is the highest university patent filer in the UK and is ranked first in the UK for university spinouts, having created more than 200 new companies since 1988. Over a third of these companies have been created in the past three years. The university is a catalyst for prosperity in Oxfordshire and the United Kingdom, contributing £15.7 billion to the UK economy in 2018/19, and supports more than 28,000 full time jobs.

“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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