On June 24th, 2019, the first subject was enrolled in ILiAD Biotechnologies IB-200P multicenter, randomized, placebo-controlled, and observer-blinded study of BPZE1, a live attenuated intranasal pertussis vaccine. The vaccine is being studied in healthy adults to assess the immunological response and safety profile of single dose and two dose vaccination schedules. Approximately 300 subjects will be randomly assigned 2:1 for the first (primary) vaccination with 200 subjects assigned to BPZE1 vaccination and 100 subjects to Boostrix™ (currently marketed vaccine). Half of the subjects in each primary vaccination group will receive a second (boosting) BPZE1 vaccination and half will receive placebo.
The primary immunogenicity outcome is the proportion of subjects who achieve seroconversion against at least 1 pertussis antigen in nasal secretions on Day 29 or 113 (prime or prime + boost). The primary safety outcomes are solicited AE’s for 7 days post each vaccination and safety laboratory results. Important secondary measures are systemic immunogenicity (IgG, IgA, and IgG or IgA) including the proportion of subjects that are seropositive to 2 or more pertussis antigens in serum, mucosal immunity including the proportion of subjects generating a seropositive response to 2 or more pertussis antigens in nasal secretions, and the proportion of subjects with BPZE1 nasopharyngeal colonization after boosting vaccination.
The study is being managed by Pharmaceutical Product Development, LLC (PPD), a leading global contract research organization, through its vaccines development group, which has supported more than 145 vaccine clinical trials across more than 50 countries and 80,000 subjects during the past five years.
“PPD is excited to provide its extensive vaccines expertise to this important partnership with ILiAD to develop a novel product to help combat ongoing pertussis epidemics,” said Les Enterline, global head of project management for PPD’s vaccines development group. “Our team is focused on supporting several aspects of this trial, including clinical study design, strategy and operational execution.”
“Advancing BPZE1 to Phase 2b is another important milestone for ILiAD, and a promising step forward for global health,” said Dr. Keith Rubin, Chief Executive Officer of ILiAD. “The need for a safe and more effective pertussis vaccine is well recognized, and BPZE1’s ability to induce robust mucosal and systemic immunity continues to be supported by ongoing evidence, giving us further confidence that we can deliver on our mission to eradicate disease due to B. pertussis.”
BPZE1 is the most advanced next generation pertussis vaccine in the world. 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), BPZE1 is designed to overcome deficiencies of current vaccines, including poor durability and failure to prevent nasopharyngeal Bordetella pertussis infections that lead to escape mutants and transmission to vulnerable infants. In 2018, a Phase 2a BPZE1 study was initiated at the Vanderbilt Vaccine and Treatment Evaluation Unit (VTEU), sponsored by the National Institute of Allergy and Infectious Disease (NIAID) at the National Institute of Health (NIH). Prior to the Phase 2a, two Phase 1 studies have been completed at the Karolinska University Hospital in Stockholm.
The company also announces the addition of Ariel Pablos-Mendez, MD to the Executive Board of Managers and George Siber, MD to the Scientific Advisory Board. Having made major contributions to global public health for decades, Dr. Pablos-Mendez is currently a Professor of Medicine at Columbia University Medical Center, and previously served as Managing Director of the Rockefeller Foundation, and former Assistant Administrator for Global Health at USAID under President Obama (2011-2016). An accomplished physician scientist, Dr. Siber is an infectious disease trained physician with more than 35 years of experience developing vaccines and antibody products. He is currently Chief Scientific Officer at ClearPath Vaccines, and from 1996 to 2007 served as Executive Vice President and Chief Scientific Officer of Wyeth Vaccines (now Pfizer).
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.
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.
About PPD
PPD is a leading global contract research organization providing comprehensive, integrated drug development, laboratory and lifecycle management services. The company’s clients and partners include pharmaceutical, biotechnology, medical device, academic and government organizations. With offices in 48 countries and more than 21,000 professionals worldwide, PPD applies innovative technologies, therapeutic expertise and a firm commitment to quality to help clients and partners bend the cost and time curve of drug development and optimize value in delivering life-changing therapies to improve health. For more information, visit www.ppdi.com.
“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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