NEW YORK, July 05, 2017 (GLOBE NEWSWIRE) -- ILiAD Biotechnologies, LLC (ILiAD), a clinical stage biotechnology company, today announced promising results from its Phase 1b pertussis vaccine clinical trial conducted in Stockholm, Sweden, as well as publication of a landmark non-human primate study.
The Phase 1b dose escalation clinical trial included a single intranasal BPZE1 administration to healthy adults in three consecutive dose groups (107, 108 and 109 CFU). The purpose of the study was to demonstrate safety of ILiAD’s next generation pertussis vaccine at higher doses and volume than a prior study, as well as to investigate whether a greater proportion of subjects attain BPZE1-induced immune responses by dose escalation.
"We are highly encouraged by the safety, vaccine take, and robust immunological results from this study,” said Keith Rubin, MD, Chief Executive Officer of ILiAD. “Our close collaboration with the French National Institute of Health and Medical research (Inserm) and the Institut Pasteur de Lille (IPL), and the diligent efforts of clinical research teams at the Karolinska Trial Alliance (KTA), Karolinska University Hospital, the Public Health Agency of Sweden (PHAS), Inserm, and EUCLID/F-CRIN Clinical Trials Platform have enabled successful completion of this major clinical milestone.”
Greater than 80% of subjects vaccinated with BPZE1 (including all dosage groups) showed positive cultures for transient colonization of the nasopharynx, a key step to immune induction. In the highest BPZE1 dose group, more than 90% of subjects had a seropositive immunological response to 2 or more of the four antigens tested (pertussis toxin, pertactin, FHA, and fimbriae). After completing two Phase 1 clinical studies and with 78 subjects vaccinated with BPZE1 at a range of doses, there have been no vaccine-related serious adverse events.
In addition to human clinical results, the company announced publication of a seminal BPZE1 research article in the Journal of Infectious Diseases (link). In this study, which utilized the FDA developed non-human primate challenge model, BPZE1 vaccination successfully prevented both whooping cough and 99.9% of upper airway B. pertussis colonization. In the publication, Camille Locht, PhD, lead author and co-inventor of BPZE1 and head of the Center for Infection and Immunity at the Institut Pasteur de Lille stated, “By not only preventing whooping cough disease, but by also substantially reducing nasopharyngeal B. pertussis load, BPZE1 may halt transmission and prove invaluable in reducing the subclinical reservoir of nasopharyngeally colonized individuals.”
Summarizing the importance of the Phase 1b and NHP studies, Adel Mahmoud, Chairman of ILiAD’s Scientific Advisory Board and former President of Merck Vaccines remarked, “BPZE1 continues to demonstrate excellent safety and immunogenicity, and addresses the critical public health need for an improved pertussis vaccine.“
ILiAD Biotechnologies has raised more than $8.5 million to date and plans to initiate a Phase 2a BPZE1 study in the first half of 2018. BPZE1 technology is covered by 25 issued patents, with an additional 29 patents pending around the world.
About Pertussis
Pertussis 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. From the introduction of the first vaccine in the 1940s until the 1970s, the number of U.S. pertussis cases dramatically declined. But rates began to rise in the 1980s, and accelerated in the mid-1990s after the introduction of acellular pertussis (aP) vaccines. By 2012, the number of U.S. cases reached a 50-year high. 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 (e.g. 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. Walter Greenblatt & Associates (www.wgreenblatt.com), an investment bank focused on life science companies, serves as the exclusive financial advisor to ILiAD.
About Inserm
Founded in 1964, the French National Institute of Health and Medical research (Inserm, www.inserm.fr) is a public science and technology institute, jointly supervised by the French Ministry of National Education, Higher Education and Research and the Ministry of Social Affairs, Health and women’s Rights. Inserm is the only French public research institute to focus entirely on human health and positions itself on the pathway from research laboratory to the bed of the patient. The mission of its scientists is to study all diseases, from the most common to the rarest. With a budget of 989 million euros in 2014, Inserm supports more than 300 laboratories across France. In total, the teams include nearly 15,000 researchers, engineers, technicians, post-doctoral students, etc. Inserm is a member of the National Alliance for Life and Health Sciences, founded in April 2009 with CNRS, Inserm, the CEA, INRA, INRIA, the IRD, the Pasteur Institute, the Conference of University Presidents (CPU) and the Conference of Chairmen of The Regional and University Hospital Centres. This alliance forms part of the policy to reform the research system by better coordinating the parts played by those involved and by strengthening the position of French research in this field through a concerted plan.
About Institut Pasteur de Lille (IPL)
The Institut Pasteur de Lille (www.pasteur-lille.fr) is a non-profit private foundation. It was created 120 years ago, was the birthplace of the BCG vaccine at the turn of the twentieth century and now hosts approximately 700 persons devoted to people’s health for “a better and longer life”. Since its creation, the mission of Institut Pasteur de Lille is to prevent major contemporary diseases by understanding them and their underlying mechanisms, acting directly on their environment and advancing the evolution of human behavior. Today, in the medical research department, 32 research teams focus on a range of human disease including infectious diseases and immunopathologies, cardio-vascular diseases, diabetes and metabolic diseases, cancer and neuro-degenerative diseases.
"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.