ILiAD Biotechnologies has contracted Emmes Group to run a Phase III trial of BPZE1, its candidate by Bordetella pertussis vaccine.
The Florida, US–based biotech announced the move last week, explaining it selected the contract research organization (CRO) based on its experience in vaccine development and the management of complex clinical trials.
ILiAD describes BPZE1 as a technologically advanced pertussis vaccine that contains genetic modifications to eliminate, attenuate or inactivate three different B. pertussis toxins.
The product is delivered intranasally – using the VaxINator device. According toILiAD, nasal administration means BPZE1 has the potential to be more effective and induce broader immunity than vaccines delivered by intramuscular injection.
ILiAD said the study will be carried out at research sites across North America, Central and South America, UK and other global clinical research centers.
Selection process
Keith Rubin, CEO of ILiAD Biotechnologies, citied Emmes’ VaxTrials and Veridix AI units as key to the deal, commenting that their “capabilities will be instrumental in executing our BPZE1 vaccine clinical development plan.”
VaxTrials unit has previously demonstrated proficiency and clinical trial excellence through their successful support of ILiAD’s Phase II IB-201P BPZE1 study.
The study showed that “Lyophilized BPZE1 vaccine was well tolerated and immunogenic at the highest dose (109 CFU) delivered intranasally by VaxINator device and was not associated with any SAEs or prolonged shedding of BPZE1.”
Emmes acquired Panama-headquartered VaxTrials, citing a desire to expand its reach into central and South America as the driver for the deal. At the time, the firm claimed VaxTrials had carried out vaccine-related trials in 11 Latin American countries.
Veridix artificial intelligence (AI) – Emmes’ artificial intelligence trial technology unit – began operating earlier this year. Emmes said the new unit would use its AI technology to optimize clinical research.
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