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Phase 1b Clinical Trial of BPZE1 Pertussis Vaccine Completes Enrollment of Randomized Study Groups

NEW YORK, Feb. 19, 2016 (GLOBE NEWSWIRE) -- ILiAD Biotechnologies, LLC (ILiAD), a clinical stage biotechnology company, announced today that enrollment has been completed for three randomized groups of study subjects in a Phase 1b vaccine clinical trial being conducted in Stockholm, Sweden.

The Phase 1b clinical trial is studying two higher doses and volumes of BPZE1, 108 CFU and 109 CFU, as a follow-up to a prior Phase 1 BPZE1 trial published in the journal PLOS One (R. Thorstensson, “A phase I clinical study of a live attenuated Bordetella pertussis vaccine – BPZE1”, Jan. 8, 2014; 9:e83449). The original study indicated that BPZE1 is safe in healthy adults at doses up to 107 CFU and can induce immune responses targeting Bordetella pertussis (B. pertussis) bacteria. The purpose of the current study is to demonstrate safety at higher doses, as well as to investigate whether a greater proportion of subjects attain BPZE1-induced immune responses by dose escalation.

BPZE1 is a next generation pertussis vaccine designed to induce comprehensive immunity and provide durable protection against whooping cough. Moreover, BPZE1 has been 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.

BPZE1 was developed in the laboratory of Dr. Camille Locht and licensed to ILiAD from the French National Institute of Health and Medical Research (Inserm) and the Institut Pasteur de Lille (IPL) by Inserm Transfert and IPL. As part of a collaboration agreement with Inserm/IPL, ILiAD supports applied research in Dr. Locht’s lab and funds the Phase 1b trial. “This is a wonderful example of a private public partnership. We have managed to build an international consortium bringing together complementary expertise in all aspects of vaccine development. For more than two years, the consortium has been effectively working together in a collegial and mutually respectful atmosphere,” said Dr. Camille Locht, head of the Center for Infection and Immunity at Lille, supported by Inserm and IPL.

ILiAD has raised more than $5 million to date and, in addition to Phase 1b enrollment, has achieved several key milestones. BPZE1 technology is covered by 14 issued patents, with an additional 30 patents pending around the world. In a non-human primate model, ILiAD has demonstrated that BPZE1 effectively protects against both whooping cough and B. pertussis nasopharyngeal colonization. This is in contrast to a 2014 study by FDA researchers in the same animal model wherein a pertussis vaccine currently marketed in the U.S. showed no reduction in the duration of B. pertussis nasopharyngeal colonization versus controls.

Keith Rubin, MD, Chief Executive Officer of ILiAD stated, "Enrollment of subjects in the Phase 1b study is an important milestone for our company and has resulted from the strong collaboration between ILiAD, Inserm and IPL, and the dedication of the clinical research teams in Stockholm, the Public Health Agency of Sweden (PHAS), Inserm, and EUCLID”. Dr. Rubin added, “In light of increasing evidence that nasopharyngeal B. pertussis colonization is a critical factor in the rise of pertussis disease, and given the promise of BPZE1 to induce potent mucosal immunity, our latest clinical milestone is another example of ILiAD’s commitment to commercialize BPZE1 and solve the global problem of pertussis once and for all.”

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
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.


Press Contact: Ken Solovay VP of Development ILiAD Biotechnologies, LLC ken@iliadbio.com Céline Cortot Communications Director Inserm Transfert Celine.cortot@inserm-transfert.fr +33 1 55 03 01 68 Yves Lemoine Technology Transfer Manager Institut Pasteur de Lille yves.lemoine@pasteur-lille.fr +33320877912

Source:ILiAD Biotechnologies, LLC