-- Bivalent SCB-1019 significantly boosted
RSV-A and RSV-B neutralizing antibody titers in older adults up to
approximately 7,900 IU/mL (up to 8-fold increase) and approximately
46,700 IU/mL (up to 11-fold increase), respectively --
-- Favorable safety & reactogenicity
profile comparable to saline placebo --
-- Full Phase Ⅰ data readout is
planned by year-end 2024 --
SHANGHAI, June 18,
2024 /PRNewswire/ -- Clover Biopharmaceuticals,
Ltd. (Clover; HKEX: 02197), a global commercial-stage biotechnology
company committed to unleashing the power of innovative vaccines to
save lives and improve health around the world, today announced
positive preliminary immunogenicity and safety data in the older
adult & elderly cohort from its Phase Ⅰ trial evaluating
SCB-1019 – the company's bivalent RSV prefusion-stabilized F
(PreF)-Trimer subunit vaccine candidate – which is based on
Clover's Trimer-Tag vaccine technology platform. These preliminary
results in older adults & elderly cohort (aged 60-85) are
consistent with the positive results in younger adults (aged 18-59)
announced earlier this year.
"As the first RSV PreF vaccine candidate developed in
China to enter the clinical trial
stage and generate clinical data, SCB-1019 Phase Ⅰ results in older
adults demonstrate broad and significant neutralizing antibody
responses against both RSV-A and RSV-B as well as a favorable
tolerability profile," said Joshua
Liang, Chief Executive Officer & Board Director of
Clover. "We look forward to the full Phase Ⅰ clinical readout
by the end of 2024 to support further development and strengthen
our potentially differentiated profile for markets globally."
In the ongoing Phase Ⅰ trial, 48 subjects were enrolled in the
older adult & elderly cohort and received either SCB-1019 or
saline placebo. Preliminary results for RSV neutralizing antibodies
(nAbs) and safety for SCB-1019 at the selected dose-level are
summarized below:
Immunogenicity Results
- RSV-A nAbs: SCB-1019 induced geometric mean titers (GMTs) in
RSV-A nAbs of up to 7,906 IU/mL compared to 1,078 IU/mL for placebo
at Day 28.
- RSV-B nAbs: SCB-1019 induced geometric mean titers (GMTs) in
RSV-B neutralizing antibody titers (nAbs) of up to 46,674 IU/mL
compared to 12,185 IU/mL for placebo at Day 28.
- Geometric Mean Fold Rise (GMFR): High baseline nAb titers
at Day 0 (pre-vaccination), especially to RSV-B, were observed,
potentially reflecting recent outbreaks near the clinical trial
sites. Thus, sub-analysis in subjects with the lowest quartile
baseline nAb titers was performed:
- GMFRs for SCB-1019 were up to 8-fold for RSV-A nAbs and 11-fold
for RSV-B nAbs at Day 28 compared to Day 0 (pre-vaccination).
- No increases in RSV-A or RSV-B nAbs were observed for placebo
at Day 28.
- nAb results across both RSV-A and RSV-B appear to be in-line or
potentially favorable compared to other protein subunit RSV PreF
vaccines1, 2, 3 and
continue to be supportive of Clover's bivalent RSV-A/B approach,
given that other monovalent RSV-A vaccines have previously observed
lower immune responses and/or efficacy against RSV-B 1, 4,
5.
- Results further confirm that Clover's PreF antigens in
SCB-1019 are in the stabilized prefusion and trimeric form,
additionally supported by exploratory immunogenicity results
demonstrating significant increases in Site Ø and Site V
nAb-competitive titers.
Safety & Reactogenicity Results
- SCB-1019 was generally well-tolerated. Local and systemic
adverse events (AEs) were generally mild for SCB-1019 and were
comparable to saline placebo.
- No serious adverse events (SAEs), adverse events of special
interest (AESIs), or AEs leading to discontinuation were
observed.
- Results indicate that SCB-1019 could potentially have a
differentiated and favorable safety & reactogenicity profile
compared to currently-approved oil-in-water adjuvanted4
and/or mRNA5-based RSV vaccines.
The Phase Ⅰ clinical trial in Australia is a randomized, placebo-controlled
study to assess the safety, reactogenicity and immunogenicity of
SCB-1019 at multiple dose levels and in different formulations in
young and older adults. Full safety and immunogenicity results in
the Phase Ⅰ clinical trial are expected by the end of 2024 to
support further development and strengthen our potentially
differentiated profile for markets globally.
1 Icosavax Company
Presentations (28-JUN-2022 & 22-MAY-2023) and Press Release
(12-DEC-2023)
|
2 NIH DS-Cav1 (DOI:
10.1016/S2213-2600(21)00098-9)
|
3 Pfizer (DOI:
10.1093/infdis/jiab612)
|
4 GSK ACIP Presentation
(21-JUN-2023)
|
5 Moderna ACIP Presentation
(29-FEB-2024)
|
About Clover
Clover Biopharmaceuticals is a global commercial-stage
biotechnology company committed to unleashing the power of
innovative vaccines to save lives and improve health around the
world. With integrated research and development, manufacturing and
commercial capabilities as well as strong partnerships with
organizations globally, Clover has a diverse pipeline of candidates
that have the potential to meaningfully reduce the burden of
vaccine-preventable diseases—and to make more diseases
preventable.
Clover Forward-looking Statements
This press release contains certain forward-looking statements
and information relating to us and our subsidiaries that are based
on the beliefs of our management as well as assumptions made by and
information currently available to our management. When used, the
words "aim," "anticipate," "believe," "could," "estimate,"
"expect," "going forward," "intend," "may," "might," "ought to,"
"plan," "potential," "predict," "project," "seek," "should,"
"will," "would" and the negative of these words and other similar
expressions, as they relate to us or our management, are intended
to identify forward-looking statements. Forward-looking
statements are based on our current expectations and assumptions
regarding our business, the economy and other future conditions. We
give no assurance that these expectations and assumptions will
prove to have been correct. Because forward-looking statements
relate to the future, they are participant to inherent
uncertainties, risks and changes in circumstances that are
difficult to predict. Our results may differ materially from those
contemplated by the forward-looking statements. They are neither
statements of historical fact nor guarantees or assurances of
future performance. We caution you therefore against placing undue
reliance on any of these forward-looking statements. Any
forward-looking statement made by us in this document speaks only
as of the date on which it is made. Factors or events that could
cause our actual results to differ may emerge from time to
time.
Clover Biopharmaceuticals:
Corporate Communication: Lola
Cao
media@cloverbiopharma.com
Investor Relations: Michael
Tu
investors@cloverbiopharma.com
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SOURCE Clover Biopharma