Selected serum samples from the BPZE1 Adult Phase 2b study tested in a serum bactericidal assay showed that BPZE1 induced killing of both PRN(-) and PRN(+) B. pertussis strains, while Boostrix only induced killing against PRN(+) B. pertussis
ILiAD Biotechnologies, LLC (ILiAD) presented a breakthrough finding today on the effect of BPZE1, a live attenuated intranasal pertussis vaccine, on serum bactericidal activity (SBA) against PRN(+) and PRN(-) Bordetella pertussis strains at the virtual ID Week 2021 conference (sponsored by Infectious Disease Society of America). Pertactin (PRN) is a highly immunogenic virulence factor secreted by Bordetella pertussis (B. pertussis). Evolutionary changes in B. pertussis in response to selection pressure from acellular pertussis (aP) vaccines are believed to have led to variant strains that are PRN deficient (PRN-).
In this post-hoc study, selected serum samples with a broad range of IgG serum antibody concentrations from adult subjects in a Phase 2b study who received BPZE1 or Boostrix (a tetanus, diphtheria, and acellular pertussis (Tdap) vaccine), were evaluated for induction of serum bactericidal antibodies to PRN(+) and PRN(-) B. pertussis strains. The previously published SBA assay (Link) was developed in the lab of Andrew Gorringe Ph.D., at Public Health England (PHE). PHE performed testing on serum samples from BPZE1 and Boostrix vaccinated subjects, which were analyzed in a blinded fashion.
As summarized in Scientific Poster #1183 (Link) and presented by lead author Cheryl Keech M.D. Ph.D. in an oral presentation, the study showed that while BPZE1 and Boostrix induced significant increases (>75% subjects with 2x fold rise) in SBA against a PRN(+) B. pertussis strain, only BPZE1 induced significant increases (>75% subjects with 2x fold rise) in SBA titres against a PRN(-) B. pertussis strain. Furthermore, this preliminary set of samples from the Boostrix vaccinated group demonstrated no subjects with 2x fold rise in SBA titres against PRN(-) B. pertussis (N 0/17). Correspondingly, Boostrix SBA titres highly correlated with anti-PRN IgG antibody titres as expected, whereas BPZE1 SBA titres did not (i.e., PRN IgG antibody response is not required for BPZE1 to induce bactericidal effects in the SBA assay). These results suggest that BPZE1 produces a broad immune response mimicking natural infection.
The resurgence of B. pertussis in multiple countries has been attributed to the Tdap vaccine's limited duration of protection and inability to block nasal colonizing infections, thereby failing to alter transmission. Notably, increasing use of Tdap vaccines in recent years has been associated with the emergence of PRN(-) B. pertussis strains around the world, with PRN(-) strains now dominant in the US (85%), Australia (>80%), Sweden (69%) and Italy (55%) (Link).
"The SBA results presented at today's meeting are timely and important, especially given the emergence and rapid global increase in PRN deficient B. pertussis strains," remarked Keith Rubin, M.D., ILiAD CEO. "By inducing a broad immunogenic response effective against both PRN(+) and PRN(-) strains, BPZE1 has once again demonstrated the ability to address important immunologic limitations of current pertussis vaccines." Dr. Rubin added, "We want to thank Dr. Gorringe and his team at Public Health England for conducting the SBA assay work with precision and diligence." More comprehensive functional SBA testing from BPZE1 clinical trials is planned to further characterize BPZE1's broad immunological protection.
About Pertussis
Pertussis (whooping cough) is a serious illness in people of all ages and can be life-threatening, especially in infants. Whooping cough is caused by the highly contagious respiratory bacterium, Bordetella pertussis. People with pertussis usually spread the disease to others by coughing, sneezing or spending time in the same breathing environment. According to U.S. Centers for Disease Control and Prevention, there are an estimated 24.1 million cases of pertussis and about 160,700 deaths per year globally. For more information, go to: https://www.cdc.gov/pertussis/fast-facts.html.
About BPZE1
BPZE1 is a live attenuated vaccine and the only next generation pertussis vaccine in advanced clinical trials which is 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 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 the prevention of pertussis (whooping cough), a serious disease caused by Bordetella pertussis. For further information, please visit www.iliadbio.com or follow us on Twitter (Link).
About Public Health England
PHE exists to protect and improve the nation's health and wellbeing and reduce health inequalities. It does this through world-class science, knowledge and intelligence, advocacy, partnerships and the delivery of specialist public health services. PHE is an operationally autonomous executive agency of the UK Department of Health.
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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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Contacts:
Ken Solovay
ILiAD Biotechnologies
800.603.3525
ken@iliadbio.com
