New York, July 5th, 2017 – NEW YORK, July, 5, 2017 – 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 here). 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.