Vaccitech plc (NASDAQ: VACC), a clinical-stage biopharmaceutical
company engaged in the discovery and development of novel
immunotherapeutics and vaccines for the treatment and prevention of
infectious diseases, cancer, and autoimmune diseases, today
announced an update to the interim analysis of safety and efficacy
data from the HBV002 study (NCT04778904), which is being presented
as a poster at the 2022 EASL International Liver CongressTM by
Professor Ellie Barnes, Professor of Hepatology and Experimental
Medicine at the University of Oxford.
The updated analysis, with a data cut-off of May 9th, which now
includes 39 patients with at least three months of follow-up, shows
that VTP-300 as a monotherapy or in combination with a single
low-dose nivolumab at the time of the booster dose was safely
administered with no treatment-related serious adverse events and
two patients with mild, rapidly resolving transaminitis.
In the VTP-300 monotherapy group, meaningful and durable
reductions of HBsAg were seen in all three patients with baseline
HBsAg under 50 IU/mL. These three patients had 0.7, 0.7 and 1.4
log10 declines two months after the last dose of VTP-300. These
dramatic declines have persisted in all three patients at their
latest follow-up at five or eight months after the last dose of
VTP-300.
For the first eight patients who received VTP-300 in combination
with a single low-dose of nivolumab at the time of the booster
dose, the mean reduction in HBsAg was over 1 log10 at six months,
an effect that persisted, with a mean decline of 1.15 log10 at
eight months after the last dose of VTP-300. The effect was most
prominent in patients with baseline HBsAg lower than
1,000 IU/mL. One patient in this group developed a
non-detectable HBsAg level, which continued eight months after the
last dose of VTP-300.
No reductions ≥1 log10 were seen in patients who received two
doses of MVA-HBV, or in patients who received low-dose nivolumab
with both doses of VTP-300. These two groups were discontinued
after interim analysis.
“The immune system is likely a needed component in achieving
durable HBsAg loss that could lead to a functional cure for
patients with chronic hepatitis B (CHB),” said Dr. Henry Chan,
Honorary Clinical Professor, Faculty of Medicine, The Chinese
University of Hong Kong. “This exciting initial data supports
VTP-300’s potential as an immunotherapy that can stimulate an
antigen-specific immune response and could be a critical component
of a functional cure regimen. I look forward to following future
clinical and combination developments.” Dr. Henry Chan is a
scientific advisor to Vaccitech but not directly involved in the
HBV002 study.
A robust T cell response against all encoded antigens (core
protein, polymerase and surface antigen), measured by overnight
stimulation, was observed following VTP-300 administration, notable
for marked CD8+ T cell predominance.
“The robust T cell response and marked, durable HBsAg reduction
eight months after VTP-300 administration is remarkable,” said
Thomas Evans, M.D., Chief Scientific Officer of Vaccitech. “We
believe the prominent effect we are observing in patients with
lower starting HBsAg levels supports the collaborative study with
Arbutus Biopharma’s siRNA, AB-729, in which HBsAg has shown to be
lowered below 100 IU/mL in a majority of treated patients.”
Enrollment in the HBV002 study is complete with
55 patients enrolled. An updated interim analysis for all patients
at the six month follow-up timepoint is expected at the end of
2022.
A trial to look at timing of low dose nivolumab
and additional doses of the MVA boost component of VTP-300
(NCT05343481) is planned in multiple countries, with the first
patient expected to be dosed in the third quarter of 2022.
HBsAg is a hallmark of chronic hepatitis B virus
(HBV) infection. Fewer than 10% of patients on current standard of
care HBV therapies ever achieve distinct, sustained HBsAg decrease
or loss, a state associated with functional cure of the
disease. The crux of chronic HBV is the immune system’s
inability to clear the virus due to insufficient immune priming
and/or aberrant immune tolerance due to large quantities of HBV
protein expression. Many involved in the field believe it makes
sense to combine an immune-stimulating agent with an HBV
protein-suppressing agent, to potentially elicit a functional cure
to HBV.
Presentation detailsPoster Title: Phase 1b/2a
study of heterologous ChAdOx1-HBV/MVA-HBV therapeutic vaccination
(VTP-300) as monotherapy and combined with low-dose nivolumab in
virally-suppressed patients with CHB on nucleos(t)ide
analogues Poster Number:
SAT-428Presenter: Ellie Barnes, Professor of
Hepatology and Experimental Medicine, Nuffield Department of
Medicine, University of OxfordAbstract: 3328
About HBV002
HBV002 is an open-label trial designed to evaluate the safety,
immunogenicity and preliminary efficacy of ChAdOx1-HBV and MVA-HBV
(VTP-300), with or without low-dose nivolumab, in patients with
chronic HBV with suppressed HBV DNA on nucleos(t)ide therapy.
As of June 22, 2022, 55 patients have been enrolled, and no
concerning safety signals or vaccine-related serious adverse events
have been reported.
Data from a previous interim analysis of HBV002 presented at the
AASLD The Liver Meeting® in November 2021 showed that VTP-300
induced antigen specific T cell responses to all antigens, with
elevated responses to core and polymerase, as compared to healthy
controls dosed with ChAdOx1-HBV alone in HBV001, who exhibited a
greater response to surface antigen. As in the HBV001 results, T
cell responses cross-reactive to Genotype D-specific peptides were
measured in the majority of patients.
About VTP-300
VTP-300 is a novel immunotherapy, dosed in a prime-boost
regimen, whereby the immune system is primed with an adenovirus
(ChAdOx1) and boosted with a pox virus (MVA). Both vectors have
been modified to improve safety, enhance the immune response they
induce and include HBV specific antigens including core, polymerase
and surface antigen. Clinical data generated to date has
demonstrated this regimen to be generally safe and well-tolerated,
that antigen specific T cell responses are stimulated to each
antigen and there were meaningful reductions in hepatitis B surface
antigen when this regimen is given alone or when given in
combination with a low dose of nivolumab at the boost.
About Vaccitech
plc.
Vaccitech (“the Company”) is a clinical-stage biopharmaceutical
company engaged in the discovery and development primarily of novel
immunotherapies for the treatment of chronic infectious diseases,
cancer, autoimmunity and diseases where the T cell arm of the
immune system is believed to play an important role. The company’s
proprietary platforms include modified simian adenoviral vectors
(ChAdOx1 and ChAdOx2), other viral vectors including the
well-validated Modified Vaccinia Ankara (MVA) and synthetic
nano-particle technologies (SNAPvax™ and Syntholytic™). The
combination of different technologies in a mix and match approach
(heterologous prime-boost) consistently generates significantly
higher magnitudes of T cells compared with other technologies and
approaches. The company has a broad pipeline of both clinical and
preclinical stage therapeutic programs to treat solid tumors,
chronic viral infections, as well as a few prophylactic viral
vaccine programs. Vaccitech co-invented a COVID-19 vaccine with the
University of Oxford, now approved for use in many territories and
exclusively licensed worldwide to AstraZeneca through Oxford
University Innovation, or OUI. Vaccitech is entitled to receive a
share of all milestones and royalty income received by OUI from
AstraZeneca.
Forward Looking
Statement
This press release contains forward-looking statements within
the meaning of the Private Securities Litigation Reform Act of
1995, as amended, including, without limitation, express or implied
statements regarding: the Company’s business plans and objectives,
including the clinical trials of ChAdOx1-HBV and the
ChAdOx1-HBV/MVA-HBV (VTP-300) and low-dose nivolumab combination,
the continued development of VTP-300 and the potential therapeutic
effects and expected patient population of VTP-300. The words
“may,” “will,” “could,” “would,” “should,” “expect,” “plan,”
“anticipate,” “intend,” “believe,” “estimate,” “predict,”
“project,” “future,” “potential,” “continue” and similar
expressions are intended to identify forward-looking statements,
although not all forward-looking statements contain these
identifying words. Any forward-looking statements in this press
release are based on management’s current expectations and beliefs
and are subject to numerous risks, uncertainties and important
factors that may cause actual events or results to differ
materially from those expressed or implied by any forward-looking
statements contained in this press release, including, without
limitation: the success, cost and timing of the Company’s product
development activities and planned and ongoing clinical trials, the
Company’s ability to execute on its strategy, regulatory
developments, the Company’s ability to fund its operations and the
impact that the current COVID-19 pandemic will have on the
Company’s clinical trials and preclinical studies and other risks
identified in the Company’s filings with the Securities and
Exchange Commission (the “SEC”), including its Annual Report on
Form 10-K for the year ended December 31, 2021 and its Quarterly
Report on Form 10-Q for the first quarter of 2022 and subsequent
filings with the SEC. The Company cautions you not to place undue
reliance on any forward- looking statements, which speak only as of
the date they are made. The Company expressly disclaims any
obligation to publicly update or revise any such statements to
reflect any change in expectations or in events, conditions or
circumstances on which any such statements may be based, or that
may affect the likelihood that actual results will differ from
those set forth in the forward-looking statements.
Vaccitech Media contacts:
Katja Stout, Scius Communications (EU) Direct: +44 (0)
7789435990Email: katja@sciuscommunications.comKatie Larch / Robert
Flamm, Ph.D., Burns McClellan, Inc. (US)Email: klarch@burnsmc.com /
rflamm@burnsmc.com
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