-- 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., Sept. 29, 2020 (GLOBE NEWSWIRE) -- 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:
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.
There were no vaccine related serious adverse events.
A single vaccination with BPZE1 prevented 90% of colonization by revaccination/challenge 3 months later (10% colonization observed).
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).
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).
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.
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.
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.
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. For further information, please visit www.iliadbio.com or follow us on Twitter.
“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.
Cherilyn Cecchini, M.D.