— Significant progress made on regulatory submissions to the China NMPA, the EMA, and the WHO for Clover’s lead COVID-19 vaccine candidate, SCB-2019 (CpG 1018/Alum), with completion anticipated in This autumn 2022 —
— New knowledge demonstrating superiority as a heterologous booster in comparison with inactivated vaccine, strong neutralization of worldwide dominant Omicron BA.5 pressure, and 84% discount in transmission of SARS-CoV-2 an infection to family contacts —
— Clover poised to turn into a singular, built-in, vaccine-focused firm with established China and world R&D, manufacturing and commercialization capabilities, and an revolutionary vaccine portfolio —
SHANGHAI, China, Oct. 09, 2022 (GLOBE NEWSWIRE) — Clover Biopharmaceuticals, Ltd. (Clover; HKEX: 02197), a world clinical-stage biotechnology firm growing novel vaccines and biologic therapeutics, right now offered updates on its 2022 company milestones.
“We have made tremendous progress towards getting our lead COVID-19 vaccine candidate across the regulatory finish line, which remains our top priority, while generating important scientific evidence that paves the way to potentially make a meaningful contribution to national booster rollouts in the near term as well as annual boosting markets in the long term,” stated Joshua Liang, Chief Executive Officer and Executive Director of Clover. “Clover is poised to become a unique, integrated vaccine-focused company with established China and global R&D, manufacturing and commercialization capabilities. We look forward to continuing to build an innovative vaccine-focused pipeline with near-term value-creation opportunities.”
“SCB-2019 (CpG 1018/Alum) remains the only domestic COVID-19 vaccine that has demonstrated superiority to inactivated vaccines, robust neutralization of the globally dominant BA.5 and significant reductions in household transmission of COVID-19, highlighting the potential meaningful and relevant impact that it could make on continued booster campaigns,” stated Dr. Nicholas Jackson, President of Global Research and Development of Clover. “We also remain excited about SCB-2020S, a second generation, potentially broadly protective COVID-19 vaccine candidate with clinical results expected in Q4 2022, as well as the continued utilization of our validated Trimer-TagTM technology to develop innovative and impactful vaccines.”
Clover’s Lead COVID-19 Vaccine Candidate
Regulatory Submissions & Manufacturing Readiness: Significant latest momentum and progress has been made on the regulatory submissions for Clover’s lead COVID-19 vaccine candidate, SCB-2019. Regulatory submissions are deliberate to be accomplished to the China National Medical Products Administration (NMPA), the European Medicines Agency (EMA), and the World Health Organization (WHO) in This autumn 2022.
- China NMPA Submission (Clover’s Changxing Facility): Clover’s in-house manufacturing facility in Changxing has made significant progress in the direction of good manufacturing apply (GMP) inspection readiness and has now accomplished beforehand recognized facility remediations and enhancements. Clover stays actively engaged with the China NMPA for the rolling conditional Biologics License Application (cBLA) submission for SCB-2019, and substantive submission-related interactions and processes have not too long ago been accomplished or are at present ongoing. The rolling submission to the China NMPA is predicted to be accomplished in This autumn 2022.
- EMA & WHO Submissions (Clover’s CDMO Facility): In September 2022, Clover’s contract improvement and manufacturing group (CDMO) acquired a European Union (EU) GMP certificates for the manufacturing of SCB-2019. The EU GMP certificates is in reference to Clover’s regulatory submission to the EMA and follows a profitable inspection of the CDMO website by the Ireland Health Products Regulatory Authority. It signifies that the manufacturing of SCB-2019 meets the EU’s requirements for high quality and security (LINK). Clover accomplished the production-related know-how switch actions for SCB-2019 on the CDMO website in Q3 2022 and expects to finish submissions to the EMA and the WHO in This autumn 2022.
- Submissions in Other Countries: In Q3 2022, Clover held submission-related conferences with regulatory authorities in Brazil and Indonesia as a part of Clover’s ongoing pursuit of regulatory submissions and potential bilateral provide agreements strategically in sure nations.
Universal COVID-19 Booster Vaccine Data: New Phase 3 knowledge demonstrating broad neutralization—together with in opposition to the globally dominant Omicron BA.5 pressure—underscores the potential position that SCB-2019 can play as a common booster in China and different nations, no matter earlier vaccination or an infection historical past and throughout age teams.
- Heterologous Booster Data for Boosting Inactivated Vaccine in Phase 3 Study: In September 2022, Clover reported constructive knowledge from its ongoing Phase 3 examine evaluating SCB-2019 as a common COVID-19 booster. Preliminary analyses demonstrated {that a} third dose of SCB-2019 in individuals who beforehand acquired two doses of the inactivated vaccine elicited 5 to 6-fold larger neutralizing immune responses in opposition to the globally dominant Omicron BA.5 pressure and different Omicron subvariants examined (BA.1, BA.2) and a 12-fold larger immune response in opposition to the unique SARS-CoV-2 pressure in comparison with individuals receiving a 3rd dose of the inactivated vaccine (LINK) (LINK).
- A sub-cohort on this ongoing Phase 3 examine is evaluating SCB-2019 as a fourth-dose booster in people who beforehand acquired three doses of the inactivated vaccine in comparison with a homologous fourth dose of the inactivated vaccine, with preliminary knowledge anticipated in This autumn 2022.
- Robust Omicron BA.5 Neutralization Responses Across Phase 2/3 Trials: The heterologous booster knowledge for inactivated vaccine is in step with outcomes introduced in August 2022 demonstrating strong responses in opposition to the dominant Omicron BA.5 pressure when SCB-2019 was administered as a third-dose homologous booster and for vaccination in topics with prior an infection (LINK).
- Substantial Reduction in Household Transmission of SARS-CoV-2 Infection: In August 2022, Clover shared new outcomes from the Phase 2/3 SPECTRA trial which demonstrated that vaccination with SCB-2019 might considerably cut back transmission of SARS-CoV-2 an infection to family contacts. Compared to placebo recipients, a person vaccinated with SCB-2019 was 84% much less prone to transmit SARS-CoV-2 an infection to a different particular person residing in the identical family (LINK). By decreasing family transmission of SARS-CoV-2 an infection, these outcomes point out that SCB-2019 can doubtlessly assist management the unfold of SARS-CoV-2 inside communities.
- Positive Adolescent Data in Phase 2/3 Trial: In August 2022, Clover introduced {that a} pivotal Phase 2/3 trial evaluating SCB-2019 in adolescents (aged 12 to 17 years) efficiently met its main endpoint and demonstrated a good tolerability and security profile, in step with outcomes beforehand noticed in adults (LINK).
Commercial Preparations & Outlook for COVID-19 Vaccine: Based on anticipated potential near-term wants in China, Clover’s precedence goal market, the corporate has begun conducting actions to allow a industrial launch after receiving regulatory approval and believes that it’s well-positioned to proceed being a key participant sooner or later longer-term annual boosting marketplace for COVID-19 vaccines.
- China Commercial Launch Preparations: Based on Clover’s progress with the continued regulatory submission, constructive heterologous booster outcomes, and the potential for a fourth-dose booster marketing campaign (LINK), Clover has been actively getting ready for the industrial launch in China after receiving regulatory approval. Clover has performed in depth area work strategically in sure precedence provinces and can proceed to have interaction with policymakers. Given the continued evolution of the SARS-CoV-2 virus and the initiation of recent booster campaigns in nations all over the world, Clover believes that, past the national-level procurement part of COVID-19 vaccine rollout, a sexy annual boosting marketplace for COVID-19 vaccines in a personal market setting might emerge over time—much like the seasonal influenza vaccination market—favoring premium merchandise akin to Clover’s adjuvanted protein-based COVID-19 vaccines.
- Update on Global Commercial Plans: In September 2022, Clover and Gavi, the Vaccine Alliance, agreed to amend their Advance Purchase Agreement (APA) to take away prior restrictions on Clover supplying vaccine doses to the China market and to deploy better pricing flexibility in China and globally via bilateral agreements. Clover had beforehand acquired US$224 million from Gavi as advance cost for buying non-refundable supplies associated to the preliminary order of 64 million doses of SCB-2019, which have now been transformed into an possibility that’s exercisable over an prolonged interval of 4 years at Gavi’s discretion however might in any other case be equipped to China or different nations. The amended APA represents Gavi’s continued collaboration and assist for Clover’s COVID-19 vaccine know-how. Clover stays dedicated to offering entry to its premier COVID-19 vaccine candidate and continues to pursue regulatory submissions and potential bilateral provide agreements strategically in sure nations.
Business Outlook & Pipeline Strategy
Clover is poised to turn into an built-in, revolutionary vaccine-focused firm with established China and world R&D, manufacturing and commercialization capabilities. Clover plans to proceed using its established inner capabilities and Trimer-TagTM know-how along with leveraging its monitor document of profitable cross-border collaboration to construct a portfolio of revolutionary and potential best-in-class vaccine candidates.
Continued Development of Trimer-Tagged Vaccines: Clover continues to leverage the validated Trimer-TagTM platform know-how to develop revolutionary protein-based vaccines.
- SCB-2020S (chimeric beta and unique pressure COVID-19 vaccine candidate): SCB-2020S, a second technology and doubtlessly broadly protecting COVID-19 vaccine candidate, is being evaluated in a Phase 1 examine in South Africa. The examine is evaluating SCB-2020S with CAS-1, Clover’s in-house adjuvant system. Safety and immunogenicity knowledge for SCB-2020S is predicted in This autumn 2022. SCB-2020S represents a possible further possibility for continued booster campaigns that might be complementary to SCB-2019.
- Pan SARS-CoV-2 Vaccine: Clover is conducting analysis to develop a multi-valent SARS-CoV-2 vaccine designed to be broadly protecting in opposition to all present and potential strains of the virus which can emerge sooner or later. A candidate choice for additional improvement is deliberate in This autumn 2022.
- SCB-1001 (Rabies G-Trimer Vaccine): Clover’s rabies vaccine candidate using Trimer-TagTM is deliberate to be developed with its in-house CAS-1 adjuvant. Additional preclinical outcomes and an replace on improvement plans for this candidate are anticipated in This autumn 2022.
Business Development for Mid- to Late-Stage Vaccine Assets: Based on Clover’s established and built-in vaccine R&D and manufacturing capabilities in addition to its monitor document of profitable cross-border collaboration, Clover is at present actively evaluating business improvement alternatives for mid- to late-stage revolutionary vaccine property which might be synergistic with its inner Trimer-Tagged vaccine portfolio and doubtlessly create vital near-term worth.
Corporate Updates
Cash Position & Business Focus:
- Cash Position: As of June 30, 2022, Clover had money and money equivalents of roughly US$336 million (RMB2,256 million), which Clover believes is ample to maintain the corporate via the industrial launch of its COVID-19 vaccine and positions the corporate for continued success. A credit score settlement with China Merchants Bank for as much as US$300 million is in place and might be accessed to assist potential working capital wants throughout industrial launch if wanted. The firm has no instant plan to entry this credit score facility presently.
- Business Focus: To navigate the challenges of the present macroeconomic surroundings, Clover has taken vital further steps to (1) heighten focus on its core strengths and capabilities in vaccine improvement and (2) prudently consider its bills and streamline the group to extend effectivity and enhance effectiveness. Non-core actions (together with monoclonal antibody platform improvement) have been terminated, and headcount reductions in non-critical positions, primarily generally and administrative capabilities and non-core R&D roles, have occurred. Clover will proceed to focus sources on attaining the corporate’s high priorities whereas persevering with to construct an revolutionary vaccine-focused portfolio that may doubtlessly generate vital near-term value-creation alternatives.
SCB-2019 (CpG 1018/Alum)
Clover developed the SCB-2019 antigen, a stabilized trimeric type of the S-protein primarily based on the unique pressure of the SARS-CoV-2 virus, and mixed it with Dynavax’s (Nasdaq: DVAX) CpG 1018 superior adjuvant and aluminum hydroxide (alum). Phase 2/3 knowledge from 30,000+ individuals throughout 5 nations confirmed that SCB-2019 (CpG 1018/Alum) achieved 100% efficacy in opposition to extreme COVID-19 and hospitalization brought on by all strains of SARS-CoV-2 circulating throughout the trial, and a doubtlessly best-in-field security profile. Clover is growing SCB-2019 (CpG 1018/Alum) as a common booster candidate for potential use no matter earlier vaccination know-how or an infection historical past. To date, these trials have proven that SCB-2019 (CpG 1018/Alum) elicited a sturdy neutralization of variants together with Omicron. Clover is pursuing regulatory approval of SCB-2019 (CpG 1018/Alum) with the China National Medical Products Administration, the European Medicines Agency, and the World Health Organization.
About Clover Biopharmaceuticals
Clover Biopharmaceuticals is a world clinical-stage biotechnology firm dedicated to growing novel vaccines and biologic therapeutics. The Trimer-Tag™ know-how platform is a product improvement platform for the creation of novel vaccines and biologic therapies. Clover leveraged the Trimer-Tag™ know-how platform to turn into a COVID-19 vaccine developer and created SCB-2019 (CpG 1018/Alum) to deal with the COVID-19 pandemic brought on by SARS-CoV-2.
For extra data, please go to Clover’s web site: www.cloverbiopharma.com and comply with the corporate on LinkedIn and Twitter.
Clover Forward-looking Statements
This press launch comprises sure forward-looking statements and knowledge referring to us and our subsidiaries which might be primarily based on the beliefs of our administration in addition to assumptions made by and knowledge at present out there to our administration. When used, the phrases “aim,” “anticipate,” “believe,” “could,” “estimate,” “expect,” “going forward,” “intend,” “may,” “might,” “ought to,” “plan,” “potential,” “predict,” “project,” “seek,” “should,” “will,” “would” and the unfavorable of those phrases and different comparable expressions, as they relate to us or our administration, are supposed to establish forward-looking statements.
Forward-looking statements are primarily based on our present expectations and assumptions concerning our business, the economy and different future situations. We give no assurance that these expectations and assumptions will show to have been appropriate. Because forward-looking statements relate to the longer term, they’re participant to inherent uncertainties, dangers and modifications in circumstances which might be tough to foretell. Our outcomes could differ materially from these contemplated by the forward-looking statements. They are neither statements of historic reality nor ensures or assurances of future efficiency. We warning you subsequently in opposition to inserting undue reliance on any of those forward-looking statements. Any forward-looking assertion made by us on this doc speaks solely as of the date on which it’s made. Factors or occasions that would trigger our precise outcomes to vary could emerge infrequently, and it isn’t attainable for us to foretell all of them. Participant to the necessities of relevant legal guidelines, guidelines and laws, we undertake no obligation to replace any forward-looking assertion, whether or not because of new data, future occasions or in any other case. All forward-looking statements contained on this doc are certified by reference to this cautionary assertion.
Clover Biopharmaceuticals:
Albert Liao
Executive Director, Corporate Communications
[email protected]
Elaine Qiu
Director, Investor Relations
[email protected]
