WESTON, Fla. and NASHVILLE, Tenn., May 15, 2018 (GLOBE NEWSWIRE) -- ILiAD Biotechnologies, LLC (ILiAD) and Vanderbilt University Medical Center today announced filing of an Investigational New Drug (IND) application by the National Institute for Allergy and Infectious Diseases (NIAID) at the National Institutes of Health (NIH) to study the next generation pertussis vaccine BPZE1 at the Vanderbilt Vaccine Research Program.
Earlier this year, NIAID and ILiAD signed a clinical trial agreement calling for NIAID to sponsor the BPZE1 Phase 2a clinical trial and for ILiAD to supply BPZE1 vaccine study product. The NIAID Division of Microbiology and Infectious Diseases (DMID) will sponsor the study through the Vanderbilt Vaccine and Treatment Evaluation Unit (VTEU), one of nine VTEUs in the United States. BPZE1 is the most advanced next generation pertussis vaccine, designed to overcome deficiencies of current vaccines, including poor durability and failure to prevent nasopharyngeal Bordetella pertussis infections that lead to transmission to vulnerable infants.
The Phase 2a clinical trial will compare a placebo control to two different doses (107 and 109 CFU) of a single intranasal BPZE1 administration in 50 healthy adults. The purpose of the study is to demonstrate preliminary safety of ILiAD’s pertussis vaccine in its lyophilized commercial formulation and to choose the optimal dose for a planned ILiAD-sponsored multicenter Phase 2b clinical study that will compare the candidate BPZE1 vaccine to Boostrix™, an FDA-licensed intramuscular acellular pertussis vaccine. The phase 2b study will enroll up to 300 healthy adult volunteers.
"We eagerly anticipate the initiation of BPZE1 U.S. Phase 2 studies and are grateful for the study support from NIAID and the study leadership of Kathryn Edwards and Buddy Creech at Vanderbilt,” said Dr. Keith Rubin, Chief Executive Officer of ILiAD. Dr. Creech, Principal Investigator for the Phase 2a study stated, “The BPZE1 intranasal pertussis vaccine has the potential to provide superior protection against B. pertussis infection and this Phase 2a study is a key next step in evaluating this important vaccine candidate.”
In addition to the NIAID-sponsored Phase 2a IND filing, ILiAD announced submission to the FDA of a Company-sponsored Phase 2b IND that is intended to initiate after analysis of 1-month immunological data from the NIAID sponsored study. Dr. Rubin added, “We continue to make excellent progress in the development of BPZE1 and are advancing our vaccine technology through a robust clinical and regulatory plan. We look forward to the outcomes from these forthcoming Phase 2 studies.”
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 (Inserm). ILiAD Biotechnologies holds global rights to the technology and has raised more than $10 million to date to further develop the most advanced pertussis vaccine in clinical trials. BPZE1 technology is covered by 33 issued patents, with an additional 25 patents pending around the world.
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 the adult nasal passage, potentially preventing transmission to infants. While ILiAD is currently focused on 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, and is focused on validating its proprietary vaccines in human clinical trials.
About NIAID
The National Institute of Allergy and Infectious Diseases (NIAID) conducts and supports basic and applied research to better understand, treat, and ultimately prevent infectious, immunologic, and allergic diseases. The Division of Microbiology and Infectious Diseases (DMID) provides funding opportunities and a comprehensive set of resources for researchers that support basic research, preclinical development, and clinical evaluation. DMID conducts and supports research on nearly 300 infectious agents and investigates the biological properties of these pathogens and the immune system’s responses to them. Findings from this research are vital to NIAID efforts to create vaccines, drugs, and diagnostic tools to better diagnose, prevent, and treat infectious diseases.
Vanderbilt Vaccine Research Program at Vanderbilt University Medical Center
The Vanderbilt Vaccine Research Program was formed in 2001 to conduct clinical and translational research in vaccines, vaccine preventable diseases, and pediatric infectious diseases. The mission of the VVRP is to reduce the burden of infectious diseases worldwide through the discovery, evaluation, and delivery of effective and safe vaccines and therapeutics.
"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.