- First BPZE1 clinical trial conducted in children
- Next generation pertussis vaccine induced broad immunity with a favorable safety profile
- Trial confirms BPZE1 and Tdap can be safely co-administered
ILiAD Biotechnologies, LLC (ILiAD) reported today that BPZE1, the most advanced next generation pertussis vaccine, demonstrated positive topline interim results in the SUPER (Stand Up to Pertussis) school-age trial conducted in 366 participants in the United Kingdom, Australia and Costa Rica. The SUPER trial is the first multi-center, placebo-controlled, randomized study of BPZE1 in healthy children 6 - 17 years of age to assess the immunological response and safety of a single intranasal dose of BPZE1 with and without co-administration of tetanus, diphtheria, and acellular pertussis (Tdap, Boostrix®).
The primary immunogenicity objective of the trial is to demonstrate induction of broad pertussis mucosal secretory immunoglobulin A (S-IgA) immunity 29 days after vaccination with BPZE1 alone or with BPZE1 + Tdap. The primary safety objective is to assess reactogenicity through 7 days following vaccination with BPZE1 alone, BPZE1 + Tdap, or Tdap alone. A key secondary objective is to demonstrate non-interference of serum immunoglobulin G (IgG) responses against Tdap-containing antigens (diphtheria, tetanus, pertussis toxin [PT], filamentous hemagglutinin [FHA], pertactin [PRN]) at Day 29 after co-administration of BPZE1 with Tdap.
Children intranasally vaccinated with BPZE1 alone and in combination with intramuscular administration of Tdap had 3.8-fold and 3.4-fold increases, respectively, from baseline levels of S-IgA against whole cell B. pertussis extract, while children vaccinated with Tdap alone had minimal increase (1.2-fold increase from baseline). In addition to induction of mucosal immunity, BPZE1 also induced broad systemic immunological antibody responses when given alone. Moreover, when given in combination with Tdap, BPZE1 induced systemic IgG responses equal to or greater than responses induced by Tdap alone. Further, co-administering BPZE1 with Tdap did not interfere with induction of tetanus or diphtheria antibody responses. Minimal reactogenicity was observed across all groups in this pediatric study, consistent with the favorable safety profile previously established in 5 adult clinical trials.
Keith Rubin, M.D., ILiAD Chief Executive Officer and Founder, commented, "BPZE1 has once again demonstrated its unique ability to safely induce potent mucosal and systemic immunity. While similar findings were previously observed in 5 adult BPZE1 clinical trials, we now have substantial evidence that the same can be said of BPZE1's ability to safely induce potent immune responses against B. pertussis in children. This immunity and potential ability to prevent transmission may one day protect not only school-age children around the world, but also their vulnerable contacts, particularly infants. This trial also provides evidence that BPZE1 can be flexibly integrated into the current vaccination schedule. Our deepest gratitude to everyone who contributed to this study, especially the children and parents who made this important milestone possible."
This is the first clinical trial in which BPZE1 has been studied specifically in subjects who received a diphtheria, tetanus, and acellular pertussis (DTaP) vaccine in infancy. Previous BPZE1 trials primarily evaluated BPZE1 in adults who received a first-generation whole cell pertussis (wP) vaccine as infants. wP vaccines are associated with greater side effects than DTaP, which has led to the replacement of wP with DTaP in most developed countries.
“School-age children are a segment of the population who have experienced an escalating rate of pertussis disease and have become a vector for transmission to vulnerable infants,” said Stephanie Noviello, M.D. Chief Medical Officer at ILiAD. “We need a vaccine that can effectively stop the spread of pertussis. In this trial, BPZE1 demonstrated induction of mucosal immunity in children, which supports its potential to prevent the pervasive cycle of B. pertussis transmission.”
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.
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 the nasal passages of adults and children, to protect adults and children 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 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 PhD and Nathalie Mielcarek PhD.
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.
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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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