- Phase 2b study in healthy volunteers met primary endpoints of overall safety and induction of mucosal immunity --

-- BPZE1 prevented colonization from re-vaccination/challenge in 90% of subjects with no vaccine related serious adverse events --

WESTON, Fla. -- ILiAD Biotechnologies, LLC (ILiAD) today presented positive topline Phase 2b trial results of its lead pertussis vaccine candidate BPZE1 at the virtual World Vaccine Congress. BPZE1, a live attenuated pertussis vaccine, met both primary endpoints of overall safety and induction of mucosal immunity.

“With limited duration of immunity and the inability to significantly stop transmission, acellular vaccines have been associated with the resurgence of whooping cough,” said Cheryl Keech, M.D., Ph.D., chief medical officer and executive vice president of clinical research at ILiAD. “We need a vaccine that can effectively stop the spread of pertussis. In this study, BPZE1 demonstrated reduced nasal colonization and induction of durable mucosal immunity — two key factors necessary for the prevention of transmission and reduction of epidemic pertussis cycles.”

Key highlights of the trial:

1. BPZE1 was well tolerated with most subjects experiencing no or mild systemic and nasal/respiratory symptoms of short duration, similar to that observed with BOOSTRIX® and placebo.
2. There were no vaccine related serious adverse events.
3. A single vaccination with BPZE1 prevented 90% of colonization by revaccination/challenge 3 months later (10% colonization observed).
4. BPZE1 was differentiated in its ability to demonstrate induction of broad mucosal immunity against whole cell extract (WCE) and pertussis-specific protein antibodies. Durability was sustained to end of study (9 months).
5. BPZE1 induced both IgG and IgA systemic immunity using WCE and pertussis-specific protein assays, with durability of response measured to end of study (9 months).
6. BOOSTRIX® induced systemic immunity as expected but was unable to prevent the level of colonization (70% colonization observed) or induce broad mucosal immunity as seen with BPZE1.

Keith Rubin, M.D., chief executive officer and founder, added, “These data provide compelling evidence that BPZE1 may finally break the transmission cycle of pertussis, which has persisted globally despite intense vaccination and boosting schedules with current acellular pertussis vaccines. BPZE1 is the only next generation pertussis vaccine in advanced clinical trials that has demonstrated the ability to prevent acquisition of pertussis, thereby holding the potential to finally stop the silent transmission that contributes to recurrent epidemics. We look forward to the continued clinical advancement of BPZE1 as we work to achieve our mission to prevent the onset and progression of disease caused by Bordetella pertussis.”

The multi-center, observer-blinded randomized trial was designed to evaluate colonization as well as mucosal and serum immune responses following vaccination with BPZE1. The trial enrolled 300 healthy volunteers ranging from 18 to 59 years old. Subjects were randomized to receive either BPZE1 or BOOSTRIX® and then challenged three months later with either BPZE1 or placebo and tested for nasal colonization. Serum and mucosal immune sampling were performed through the end of the study.

About Pertussis
Pertussis (whooping cough) is a serious illness in people of all ages and can be life- threatening, especially in infants. Whooping cough is caused by the highly contagious respiratory bacterium, Bordetella pertussis. People with pertussis usually spread the disease to others by coughing, sneezing or spending time in the same breathing environment. According to U.S. Centers for Disease Control and Prevention, there are an estimated 24.1 million cases of pertussis and about 160,700 deaths per year globally. For more information, go to https://www.cdc.gov/pertussis/fast-facts.html.

About BPZE1
BPZE1 is a live attenuated vaccine and the only next generation pertussis vaccine in advanced clinical trials which is designed to protect against Bordetella pertussis nasal infection (colonization) and active disease through the induction of broad and sustained mucosal and systemic immunity. BPZE1 is currently being developed as a booster vaccine with future development investigating its application as a primary vaccination in infants.

Contacts

Ken Solovay
ILiAD Biotechnologies
954.336.0777
ken@iliadbio.com

Media
Cherilyn Cecchini, M.D.
LifeSci Communications
646-876-5196
ccecchini@lifescicomms.com