Pertussis vaccine(INSERM)

Multiple Phase III studies are expected to be conducted across North America, Central and South America, UK and other global clinical sites VaxTrials, part of Emmes Group, selected to provide comprehensive clinical research services Veridix AI, part of Emmes Group, to provide Advantage eClinical and other platform capabilities critical to accelerate and improve study execution WESTON, Fla.--(BUSINESS WIRE)--iLiAD Biotechnologies, LLC, a late-stage biotech development company dedicated to the prevention of disease caused by Bordetella pertussis, today announced the selection of Emmes Group, a global contract research and technology organization, to conduct upcoming Phase III studies of its lead pertussis vaccine candidate, BPZE1. ILiAD and Emmes Group are currently working to finalize the definitive agreement. ILiAD selected Emmes Group for their expertise in vaccine development, agility in managing complex clinical trials, strong local market presence, and their integrated technology capabilities. Emmes Groups’ VaxTrials unit has previously demonstrated proficiency and clinical trial excellence through their successful support of ILiAD’s Phase II IB-201P BPZE1 study. Dr. Keith Rubin, CEO of ILiAD Biotechnologies, commented, “Selecting Emmes Group for our Phase III BPZE1 trials has been a carefully considered strategic decision to ensure the highest standards of clinical research. VaxTrials’ specialization in vaccines and Veridix AI’s advanced technological capabilities will be instrumental in executing our BPZE1 vaccine clinical development plan.” "We are honored and pleased that ILiAD has selected Emmes Group as its partner to continue the clinical development of BPZE1. We look forward to working closely with ILiAD’s clinical development team on this promising new vaccine, which could significantly reduce the transmissibility and incidence of B. pertussis, particularly in vulnerable populations,” said Sastry Chilukuri, Chief Executive Officer of Emmes Group. 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 pertussis epidemics. About BPZE1 BPZE1 is the leading next-generation 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 nasal passages of adults and children, to protect adults and children from whooping cough, and to potentially prevent transmission, including transmission to infants. While ILiAD is currently focused on developing a vaccine to directly protect adults and children and to indirectly protect vulnerable infants, future development aims to immunize neonates directly. BPZE1 was developed at the Institut Pasteur de Lille (France) in the lab of Camille Locht PhD and Nathalie Mielcarek PhD. About ILiAD Biotechnologies, LLC ILiAD Biotechnologies ( ) 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, investigating the impact of B. pertussis in a range of human disease, and is focused on validating its proprietary vaccines in human clinical trials. About Emmes Group Emmes Group is a privately held contract research organization (CRO), wholly owned by New Mountain Capital ( ). The company is transforming the future of clinical research, bringing the promise of new medical discovery closer within reach for patients. Emmes Group was founded as Emmes more than 47 years ago, becoming one of the primary clinical research providers to the US government before expanding into public-private partnerships and commercial biopharma. Emmes Group has built industry leading capabilities in cell and gene therapy, vaccines and infectious diseases, ophthalmology, rare diseases, and neuroscience. Today, the company is transforming the future of clinical research, by creating the industry’s first native digital and AI based CRO optimized to deliver programs faster, better, and more efficiently. Where human intelligence meets artificial intelligence. For more information, visit ILiAD Biotechnologies and Emmes Group.

ILiAD Biotechnologies’ pertussis shot did not seem to interfere with the induction of tetanus or diphtheria antibody responses. After proving the efficacy of a pertussis vaccine in preventing infection, ILiAD Biotechnologies’ next challenge was to add the shot to a Trojan horse lineup of childhood vaccines to see whether they can be co-administered. The Florida-based biotech has demonstrated just that in a phase 2b trial called SUPER (Stand Up to Pertussis). BPZE1 was tested in 366 healthy school-age children in the U.K., Australia and Costa Rica. The randomized study assessed the immunological response and safety of a single dose of the nasal vaccine with and without co-administration of tetanus, diphtheria and acellular pertussis vaccines (Tdap or Boostrix). The primary goal was met, with BPZE1 achieving induction of broad pertussis mucosal secretory immunoglobulin A (S-IgA) immunity 29 days post-vaccination, according to a Tuesday release. Children who received BPZE1 alone and in combination with the other vaccines had 3.8-fold and 3.4-fold increases, respectively, of baseline S-IgA levels against B. pertussis. Children who received Tdap alone had a 1.2-fold increase from baseline. ILiAD’s shot spurred broad systemic immunological antibody responses when given alone. The shot also did not seem to interfere with the induction of tetanus or diphtheria antibody responses. Safety was tracked for the seven days after administration to assess signs of reactivity, with no red flags and a favorable profile consistent with five previous adult clinical trials. ILiAD CEO Keith Rubin, M.D., noted that similar efficacy results had previously been established in adult populations, but, now, the biotech has the data to prove the same is true in children. “This immunity and potential ability to prevent transmission may one day protect not only school-age children around the world, but also their vulnerable contacts, particularly infants,” Rubin said in a Tuesday statement. The trial helped show BPZE1 can be worked into existing vaccination schedules for children. Also known as whooping cough, pertussis is caused by a highly contagious bacteria and affects 16 million people annually. Vaccines exist to protect against the disease, but ILiAD said there remains an unmet need to address the potentially life-threatening disease.