Clover Biopharmaceuticals, Ltd. (Clover; HKEX: 02197), a global
clinical-stage biotechnology company developing novel vaccines and
biologic therapeutic candidates, today provided an update on 2022
corporate milestones.
“The recent COVID-19 surge in China has heightened the need and
urgency for increased vaccination and continued boosting with safe
and effective COVID-19 vaccines. This surge has also caused
temporary disruptions across the economy and supply chain and have
impacted some of our ongoing activities. We have devoted extensive
efforts to mitigate the impact including working closely with
regulatory authorities and thus believe getting our COVID-19
vaccine candidate across the regulatory finish lines is in sight,”
said Joshua Liang, Chief Executive Officer and Executive
Director of Clover. “With Phase 3 heterologous booster
data in individuals previously receiving 2- and 3-doses of
inactivated vaccine expected in the second half of this year, we
anticipate SCB-2019 (CpG 1018/Alum) will play a significant role in
boosting protection against Omicron in the Chinese population when
it will be greatly needed.”
"At a global level, we are still experiencing a pandemic as new
Omicron lineages emerge and the threat of new variants remains
significant. These circumstances reinforce Clover’s confidence in
the role that our protein-based COVID-19 vaccines, utilizing the
Trimer-Tag™ platform, can play in global efforts to fight against
this virus now and throughout the transition to a long term endemic
disease setting,” said Dr. Nicholas Jackson, President of
Global Research and Development of Clover. “Given the
growing evidence demonstrating that SCB-2019 induces strong booster
responses against Omicron in previously-vaccinated and
previously-infected individuals, combined with its favorable safety
and reactogenicity profile and stability under standard
refrigerated conditions, we believe that SCB-2019 (CpG 1018/Alum)
will become an important universal COVID-19 booster in China and
globally.”
Clover underscores its commitment to completing
regulatory submissions of SCB-2019 (CpG 1018/Alum) to the China
NMPA, EMA and the WHO, while concurrently mobilizing and preparing
manufacturing capabilities for global commercialization.
Additionally, Clover is ensuring a long-term, comprehensive
pipeline with the advancement of potentially broadly-protective
COVID-19 research and development programs — SCB-2020S (a
beta-variant and prototype chimeric vaccine candidate) and a
bivalent Omicron and prototype COVID-19 vaccine candidate — which
will provide further proof-of-concept for variant strain
application utilizing the Trimer-Tag™ technology platform.
SCB-2019 (CpG 1018/Alum), COVID-19
Vaccine Candidate
Regulatory
Submissions: Clover remains actively engaged with the
China NMPA, the EMA, and the WHO regarding the data needed to
support conditional approvals for SCB-2019 (CpG 1018/Alum).
- Submission and Production Strategy:
Based on the anticipated supply demands of SCB-2019 (CpG 1018/Alum)
for the China market and in order to streamline supply of the
vaccine to multiple markets simultaneously, Clover optimized its
regulatory and manufacturing strategy for 2022. In 2022, Clover’s
Changxing facility will be focused on seeking product approval with
the China NMPA and supplying vaccine for the China market. Clover’s
CDMO site – which has previously received EMA and WHO approvals –
will be focused on seeking product approvals from the EMA and the
WHO with the objective of supplying our vaccine for global markets,
including for the COVAX facility. This plan has been communicated
with and acknowledged by the relevant regulatory authorities.
- Impact of COVID-19 Outbreak in
China: COVID-19 outbreaks in Shanghai and other localities across
China have resulted in strict containment measures. This situation
has impacted certain day-to-day operations at Clover, including the
delayed delivery of certain raw materials and equipment to our
manufacturing facilities, the pause in specific testing services at
contract laboratories, and restrictions on travel to our
manufacturing facilities. Despite the logistical impact, the Clover
team has worked through the situation, and significant progress has
been made on completing improvements to the Changxing facility and
the associated CMC activities. Clover now anticipates that the
facility will be ready for GMP inspections in Q3-2022.
- Guidance for Regulatory
Submissions: The latest plans for our SCB-2019 rolling submissions
and status of our Changxing and CDMO manufacturing facilities have
been communicated with the regulatory authorities. Regulatory
submissions are now anticipated for completion in the second half
of 2022 for all three agencies, with product launch commencing
thereafter upon receiving conditional approvals.
Universal COVID-19 Booster
Vaccine Development: Clover plans to complete the
development of its COVID-19 vaccine candidate as a universal
COVID-19 booster vaccine in 2022, to potentially enable its use as
a booster dose, regardless of the vaccine technology used for the
primary vaccination or previous SARS-CoV-2 infection history.
Initial universal booster data have demonstrated that SCB-2019 (CpG
1018/Alum) can induce a significant and broadly-neutralizing immune
response against variants of concern (VoCs) including Omicron.
Heterologous Booster Boosting
CoronaVac™ (SinoVac Inactivated Vaccine) and Comirnaty® (Pfizer
mRNA Vaccine): Clover anticipates initiating a clinical trial in
the Philippines in June 2022, to evaluate SCB-2019 (CpG 1018/Alum)
as a booster for select COVID-19 vaccines including in individuals
that previously received two doses of CoronaVac™ or two doses of
Comirnaty®. SCB-2019 (CpG 1018/Alum) administered as a heterologous
booster will be compared head-to-head against homologous boosters
of CoronaVac™ and Comirnaty®, respectively. Initial results from
this trial are expected in Q3-2022.
- In this trial, Clover plans to
initiate a subcohort evaluating SCB-2019 (CpG 1018/Alum) as a
booster in individuals previously receiving three doses of
CoronaVac™, which is expected to begin enrolling in Q3-2022 with
initial results expected in Q4-2022.
- Separately, Clover recently
received an update from investigators in an ongoing
investigator-initiated study in Brazil evaluating SCB-2019 (CpG
1018/Alum) used as a booster in individuals previously receiving
two doses of CoronaVac™. Since the CoronaVac™ booster study group
had met significant challenges with enrollment due to a preference
for other licensed vaccines, the investigators and study funders
have decided to terminate the study.
Homologous Booster
- Boosting SCB-2019 (CpG 1018/Alum):
A homologous booster dose of SCB-2019 (CpG 1018/Alum) in
individuals previously receiving two doses of SCB-2019 (CpG
1018/Alum) induced a robust and rapid neutralizing antibody immune
response that exceed levels after the primary immunization series
by approximately 5-fold. The safety and reactogenicity profile of
the homologous booster dose was consistent with the primary
immunization series. The study evaluated SCB-2019 (CpG 1018/Alum)
in 3,755 participants in Brazil, the Philippines and Columbia.
- Additional data from this trial
including Omicron neutralization results and a cohort boosted with
a half-dose of SCB-2019 (CpG 1018/Alum) are expected to be
available in the middle of the year.
Promising Next-Generation COVID-19
Vaccine Candidates
- SCB-2020S (prototype and
beta-variant chimeric vaccine candidate): Clover initiated a Phase
1 clinical trial in South Africa evaluating SCB-2020S in May 2022.
Preliminary results are expected in Q4-2022. The results will
provide further proof-of-concept for variant strain change
utilizing the Trimer-Tag™ technology platform and will also
generate first-in-human data for CAS-1 (an in-house oil-in-water
emulsion adjuvant).
- Bivalent Vaccine (prototype and
omicron-variant combined formulation vaccine candidate): Clover has
nominated a bivalent candidate vaccine into its development
portfolio based on promising preclinical data against VOCs. The
manuscript “Cross-Protection to VOCs by Bivalent S-Trimer
COVID19 Vaccine” is available for pre-print on
bioRxiv and has been accepted by a peer-reviewed scientific
journal.
Other Business Updates: After
completing internal scientific, financial, and strategic
assessments, Clover will prioritize resources on the development of
COVID-19 assets and certain early-stage programs/platforms while
limiting investments in non-COVID-19 mid/late-stage programs and
new infrastructure. In navigating the current macroeconomic
environment, Clover continues to prudently evaluate its expenses
and explore opportunistic financing options to extend its cash
runway.
- Focused on Near-term Value Drivers:
Regulatory submissions for SCB-2019 (CpG 1018/Alum) remains
Clover’s highest priority. Clover is also maximizing its impact on
COVID-19 by completing universal booster development for SCB-2019
(CpG 1018/Alum) and advancing additional COVID-19 vaccine
candidates including SCB-2020S and a bivalent COVID-19 vaccine
candidate. SCB-219M will also advance into a Phase 1 in the
near-term. Additional investments in SCB-313 (TRAIL-Trimer for
oncology), SCB-808 and SCB-420 (Fc-Fusion protein programs) have
been paused for the time being.
- Up to US$300 Million Credit
Agreement Approved: China Merchants Bank has approved a one-year
credit agreement for up to US$300 million to support potential
working capital needs during commercial launch. Drawdown on this
agreement is subject to a review of Clover’s business condition and
changes in Clover’s condition may result in early repayment.
Additional terms including the repayment date and interest rate
will be fixed at the time of drawdown approval.
About SCB-2019 (CpG 1018/Alum)
SCB-2019 (CpG 1018/Alum), our lead COVID-19 vaccine candidate,
is anticipated to potentially be one of the first protein-based
COVID-19 vaccines commercialized globally through the COVAX
Facility. Employing the Trimer-Tag™ technology platform, Clover
developed the SCB-2019 antigen, a stabilized trimeric form of the
S-protein (referred to as S-Trimer™) based on the original strain
of the SARS-CoV-2 virus. Clover created its COVID-19 vaccine
candidate by combining SCB-2019 with Dynavax’s (Nasdaq: DVAX) CpG
1018 advanced adjuvant and aluminum hydroxide (alum).
About Clover Biopharmaceuticals
Clover Biopharmaceuticals is a global clinical-stage
biotechnology company committed to developing novel vaccines and
biologic therapeutic candidates. The Trimer-Tag™ technology
platform is a product development platform for the creation of
novel vaccines and biologic therapies. Clover leveraged the
Trimer-Tag™ technology platform to become a COVID-19 vaccine
developer and created SCB-2019 (CpG 1018/Alum) to address the
COVID-19 pandemic caused by SARS-CoV-2.
For more information, please visit Clover’s website:
www.cloverbiopharma.com and follow the company on LinkedIn.
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, and it is not possible for us to predict
all of them. Participant to the requirements of applicable laws,
rules and regulations, we undertake no obligation to update any
forward-looking statement, whether as a result of new information,
future events or otherwise. All forward-looking statements
contained in this document are qualified by reference to this
cautionary statement.
Clover
Biopharmaceuticals:
Cindy MinSVP, Public
Affairsmedia@cloverbiopharma.com
Naomi EichenbaumVP,
Investor Relationsinvestors@cloverbiopharma.com
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