ILiAD Biotechnologies today announced that the National Institute of Allergy and Infectious Diseases (NIAID) at the National Institutes of Health (NIH) has selected ILiAD’s B-Tech Vector Technology for funding as part of its newly created Innovation for Tuberculosis Vaccine Discovery (ITVD) program. This program supports novel innovative vaccine candidates for the prevention of tuberculosis.

According to the NIH grant funding opportunity announcement, “the WHO estimates that in 2019, 10 million persons fell ill with tuberculosis (TB) and 1.4 million succumbed to the disease. While significant advances have been made in recent years, effective interventions to prevent ongoing transmission and disease in high burden settings are sorely lacking. Vaccines that either prevent infection or transition to active TB are urgently needed to significantly decrease the global burden and ultimately reach the goal of ending TB.”

ILiAD’s B-Tech Vector Platform utilizes a proprietary attenuated Bordetella pertussis (B. pertussis) strain as an intranasal vaccine vector to express pathogen target antigens, inducing both systemic and respiratory mucosal immunologic responses. B-Tech Vector Platform vaccines have demonstrated immunogenicity in 8 peer-reviewed published pre-clinical studies targeting viruses, bacteria, and parasites. The induction of mucosal immunity is key to preventing infection and transmission of respiratory pathogens, and induction of memory B and T cells plays a central role.

ILiAD collaborators for the NIH grant include co-principal investigator Dr. Camille Locht (co-inventor of the B-Tech Technology), Inserm Unit U1019 located at Institut Pasteur de Lille (Lille, France), ILiAD’s wholly owned subsidiary, BioLyo Technologies B.V. (Ghent, Belgium), and The Commissariat à l’énergie atomique et aux energies alternatives (CEA) department of Infectious disease models for innovative therapies (IDMIT) (Fontenay-aux-Roses, France). Initial funding for the first 3 years is ~$1,000,000. The program aims to successfully demonstrate protection in pre-clinical TB challenge models, supporting eventual clinical development.

Peter Goldstein, Executive Director of Vaccine Platform Development and lead investigator for the TB vaccine program at ILiAD stated, “ILiAD’s intranasal B-Tech Vector platform induces immune protection precisely at the point of TB entry, the respiratory tract and lungs, which is promising for the development of a TB vaccine. In addition, our respiratory bacteria-based platform may also have an inherent advantage in its ability to induce immunological protection against other pathogenic respiratory bacteria such as TB.”

In addition to preclinical development of B-Tech Vector vaccines for TB and other targets, ILiAD continues to advance its BPZE1 pertussis vaccine through late-stage clinical development. BPZE1 has received FDA Fast Track designation and is the Company’s most advanced vaccine candidate.

About ILiAD Biotechnologies, LLC

ILiAD Biotechnologies is utilizing its B-Tech technology to develop next generation vaccines to prevent infectious diseases and improve lives. Its lead candidate, BPZE1, is the most advanced next generation vaccine for the prevention of pertussis (whooping cough), a serious disease caused by Bordetella pertussis. Additional vaccines using the B-Tech Vector Platform are in development. For further information, please visit www.iliadbio.com or follow us on Twitter (Link).

About BioLyo Technologies, BV

BioLyo Technologies is a wholly owned subsidiary of ILiAD Biotechnologies, focused solely on providing process development services for live bacteria-based biologicals. There are many live vaccines and microbiome derived live biologicals in development, but few service providers have the experience to develop a robust production process capable of supporting both clinical and commercial needs. For further information, please visit www.biolyotech.com.

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.

About Inserm

Founded in 1964, the French National Institute of Health and Medical Research (Inserm) 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. www.inserm.fr

About CEA/IDMIT

The CEA is a French key player in research, development and innovation in four main areas: energy transition, digital transition, technology for the medicine of the future and defense and security. IDMIT is a department of the François Jacob Institute of Biology. The François Jacob Institute of Biology, based at the CEA Paris-Saclay sites in Fontenay-aux-Roses, Evry and the Hôpital Saint Louis, carry out research in 3 areas: radiobiology and radiotoxology, human health (on neurodegenerative and infectious diseases and on immuno-hematology), medical and environmental genomics. IDMIT is dedicated to preclinical and clinical research on human infectious diseases and immunology. Among its principal missions, it coordinates and operates a national research infrastructure for biology and health, providing its academic and industry partners with access to facilities and cutting-edge equipment for preclinical studies.

“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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