--Changxing manufacturing facility readiness and CMC activities impacted by COVID-19 outbreak in China - the facility is now expected to be ready for GMP inspections in Q3-2022 --
-- Regulatory submissions to the China NMPA, EMA, and the WHO for SCB-2019 (CpG 1018/Alum) are anticipated to be completed in the second half of 2022 --
-- Universal Booster Development: Phase 3 clinical trial evaluating SCB-2019 (CpG 1018/Alum) as a heterologous booster for CoronaVac™ and Comirnaty® expected to initiate in June 2022 --
-- Credit agreement with China Merchants Bank has been approved for up to US$300 million to support commercial launch of SCB-2019 --
SHANGHAI, China, June 05, 2022 (GLOBE NEWSWIRE) -- 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.
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.
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.
