First-In-Human Study of Immbios Novel Pneumococcal Vaccine Pnubiovax Shows Vaccine to Be Safe and Immunogenic
June 9, 2016 – Pharmaceutical –
- Antibody responses to ubiquitous antigens across
strains shown, indicative of broad protection - Statistically significant increases in antibody
response were achieved in the 200 (mid) and 500 µg (high) dose groups, in
comparison to the placebo group - 100% of subjects in the high dose group achieved a
significant immune response - Study demonstrated a dose response relationship
- Proven safety will allow further development of the
vaccine, specific to at-risk groups for pneumococcal disease
Cambridge, UK, June 30, 2016 / — ImmunoBiology Ltd (‘ImmBio’ or the
Company), a biopharmaceutical company developing next generation anti-infective
vaccines based on its proprietary ImmBioVax™ technology, reports positive
results from the First-in-Human study of its novel vaccine, PnuBioVax™,
against the bacterial pathogen Streptococcus pneumoniae (NCT02572635).
PnuBioVax was found to be safe and well tolerated, and capable of producing
antibody responses against key S. pneumoniae antigens broadly conserved
across strains. The data was presented today at the International Symposium on
Pneumococci and Pneumococcal Diseases (ISPPD), Glasgow, UK.
‘The results of this study have demonstrated the safety of PnuBioVax in
adults, and we are now looking at developing the vaccine further, focusing on
the at-risk populations for pneumococcal disease of the young and the elderly’
said Dr Chris Bailey, Development Director at ImmBio.
Graham Clarke, CEO of ImmBio, commented: ‘Demonstrating that PnuBioVax is
safe and immunogenic through this phase I clinical study is a fundamental step
in our mission to create a universal vaccine against pneumococcal disease. This
provides the real prospect of a strain-independent pneumococcal disease
prophylactic vaccine. We are now looking for partners to progress PnuBioVax
through late stage clinical development, manufacturing and marketing’.
Study Design
The randomised, double blind study assessed the safety and immunogenicity
of PnuBioVax for three different dosages (50 μg, 200 μg, and 500 μg) compared
to placebo. Doses of PnuBioVax were administered intramuscularly on three
occasions, 28 days apart. A total of 36 healthy males and females, aged 18 to
40 years, were recruited for the study.
In addition to monitoring volunteers for adverse events, antibody responses
to PnuBioVax were measured by ELISA, using blood samples taken from the
volunteers at four separate occasions throughout the study. The presence of
specific antibodies, against antigens selected for their ubiquity across
strains and role in causing disease, was also measured. The functional capacity
of these antibodies was assessed using an opsonophagocytic assay, commonly used
as an indicator of an antibodiesí ability to kill the pathogen and therefore
protect against disease. The ability of antibodies raised against PnuBioVax to
neutralise the toxic component of S.pneumoniae, Pneumolysin (Ply), was
also assessed.
Safety data
Assessment of safety data concluded that no clinically-significant changes
of vital signs, ECG and blood chemistries were observed as a result of
treatment with PnuBioVax, and, importantly, no serious adverse events were
seen. Overall, PnuBioVax was concluded to be safe and well tolerated. This is
in accordance with expectations of PnuBioVaxís safety profile as a self adjuvanting
vaccine.
Immunogenicity data
A statistically significant increase in total antibody response was seen in
the 200 and 500 µg dose groups compared to placebo, showing PnuBioVax to be
immunogenic. In addition, 100% of subjects in the high dose group achieved a
significant immune response. Response to specific disease relevant antigens,
such as Ply and Pneumococcal surface protein A (PspA) were also observed,
indicating PnuBioVaxís capability of broad protection across strains. The range
of doses used was able to demonstrate a relationship between dose and antibody
response. The study showed no clear advantage of a 500 µg dose over 200 µg dose
of PnuBioVax.
A correlation was seen between antibodies generated against Ply and
inhibition of the haemolytic effects of the pathogen on red blood cells. This
is indicative of PnuBioVaxís ability to neutralise the Ply toxin, a factor
implicated in the virulence of S. pneumoniae.
Dr Chris Bailey presented the phase I data today during the session ëInvited
Oral Poster Presentations 07: New Pneumococcal Vaccinesí at ISPPD. The abstract
can be found online, here: http://www.isppd2016.kenes.com/scientific-program-%282%29/scientific-program-2#.V2v77FUrLGg
ImmBio is also presenting three posters focused on PnuBioVax at ISPPD.
