Trimer

Clover’s Vaccine Candidate Reduced Household Transmission of SARS-CoV-2 in Study Published in Clinical Infectious Diseases

Retrieved on: 
Wednesday, November 30, 2022
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SHANGHAI, China and SEOUL, Republic of Korea, Nov. 30, 2022 (GLOBE NEWSWIRE) -- Clover Biopharmaceuticals, Ltd. (Clover; HKEX: 02197), a global clinical-stage biotechnology company developing novel vaccines and biologic therapeutics, and the International Vaccine Institute, an international nonprofit organization devoted to providing vaccines critical to global public health and based in Seoul, Korea, today announced that Clinical Infectious Diseases has published additional data from SPECTRA, a global Phase 2/3 clinical trial, that showed vaccination with SCB-2019 (CpG 1018/Alum) reduced the risk of transmitting SARS-CoV-2 infection to household members, compared to placebo participants.

Key Points: 
  • Among the 134 household contacts of infected household members who had received SCB-2019, there was one case of COVID-19; among the 250 household contacts of infected household members who were not vaccinated, there were 12 cases.
  • There were no cases of symptomatic SARS-CoV-2 infection among household contacts who were partially or fully vaccinated and where the infected household member was vaccinated with SCB-2019.
  • This indicates that SCB-2019 vaccination reduced household transmission and that vaccinated household contacts also likely benefited from the protection provided by their own vaccination.
  • The study team was blinded to the assignment of SPECTRA participants to vaccine or placebo groups.

Clover Provides Update on 2022 Corporate Milestones

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Sunday, October 9, 2022
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SHANGHAI, China, Oct. 09, 2022 (GLOBE NEWSWIRE) -- Clover Biopharmaceuticals, Ltd. (Clover; HKEX: 02197), a global clinical-stage biotechnology company developing novel vaccines and biologic therapeutics, today provided updates on its 2022 corporate milestones.

Key Points: 
  • (Clover; HKEX: 02197), a global clinical-stage biotechnology company developing novel vaccines and biologic therapeutics, today provided updates on its 2022 corporate milestones.
  • Clover is poised to become a unique, integrated vaccine-focused company with established China and global R&D, manufacturing and commercialization capabilities.
  • The rolling submission to the China NMPA is expected to be completed in Q4 2022.
  • Clover completed the production-related technology transfer activities for SCB-2019 at the CDMO site in Q3 2022 and expects to complete submissions to the EMA and the WHO in Q4 2022.

Clover’s COVID-19 Vaccine Candidate Receives European Union GMP Certificate

Retrieved on: 
Tuesday, September 20, 2022
Aluminium, Therapy, Safety, SCB-2019, COVID-19, 1018, European Medicines Agency, World, World Health Organization, Severe acute respiratory syndrome coronavirus 2, National Medical Products Administration, EU, Forward-looking statement, Vaccine, CDMO, WHO, GLOBE, NMPA, CpG, GMP, EMA, Pharmaceutical industry, Clover, Trimer

(Clover; HKEX: 02197), a global clinical-stage biotechnology company developing novel vaccines and biologic therapeutics, today announced that Clovers contract development and manufacturing organization (CDMO) has received a European Union Good Manufacturing Practice (EU GMP) certificate for the production of Clovers lead COVID-19 vaccine candidate, SCB-2019 (CpG 1018/Alum).

Key Points: 
  • (Clover; HKEX: 02197), a global clinical-stage biotechnology company developing novel vaccines and biologic therapeutics, today announced that Clovers contract development and manufacturing organization (CDMO) has received a European Union Good Manufacturing Practice (EU GMP) certificate for the production of Clovers lead COVID-19 vaccine candidate, SCB-2019 (CpG 1018/Alum).
  • The EU GMP certificate is in connection with Clovers regulatory submission to the European Medicines Agency (EMA) and follows a successful inspection of the CDMO site by the Ireland Health Products Regulatory Authority.
  • Obtaining the EU GMP certificate for SCB-2019 is a major milestone in our efforts to bring our premier COVID-19 vaccine candidate to global markets and a testament to the significant progress our team has made towards commercial readiness, said Joshua Liang, Chief Executive Officer and Executive Director of Clover.
  • Clover created its COVID-19 vaccine candidate by combining SCB-2019 with Dynavaxs (Nasdaq: DVAX) CpG 1018 advanced adjuvant and aluminum hydroxide (alum).

Clover’s Universal COVID-19 Booster Vaccine Candidate Demonstrates Superior Neutralization of Omicron BA.5 Compared to Inactivated Vaccine

Retrieved on: 
Tuesday, September 20, 2022
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SHANGHAI, China, Sept. 20, 2022 (GLOBE NEWSWIRE) -- Clover Biopharmaceuticals, Ltd. (Clover; HKEX: 02197), a global clinical-stage biotechnology company developing novel vaccines and biologic therapeutics, today announced positive data from its ongoing Phase 3 study evaluating Clover’s SCB-2019 (CpG 1018/Alum) as a universal COVID-19 booster vaccine candidate. The data showed that SCB-2019 (CpG 1018/Alum) elicited superior levels of neutralizing antibodies against the Omicron BA.5 subvariant, the dominant SARS-CoV-2 variant circulating globally today, when administered as a heterologous third dose in participants who previously received two doses of an inactivated vaccine compared to a third dose of the inactivated vaccine.

Key Points: 
  • (Clover; HKEX: 02197), a global clinical-stage biotechnology company developing novel vaccines and biologic therapeutics, today announced positive data from its ongoing Phase 3 study evaluating Clovers SCB-2019 (CpG 1018/Alum) as a universal COVID-19 booster vaccine candidate.
  • A booster dose of SCB-2019 (CpG 1018/Alum) in participants who previously received two doses of the inactivated vaccine elicited superior neutralizing immune responses against Omicron BA.5 compared to responses in participants receiving a third dose of the inactivated vaccine.
  • The Omicron BA.5 heterologous booster responses are consistent with prior data from this Phase 3 study ( LINK ), which showed a similarly superior response against the SARS-CoV-2 prototype, Omicron BA.1 and Omicron BA.2 for SCB-2019 (CpG 1018/Alum), relative to inactivated vaccine.
  • Clover is also currently enrolling a subcohort evaluating SCB-2019 (CpG 1018/Alum) as a fourth dose booster in individuals previously receiving three doses of the inactivated vaccine compared to a fourth, homologous booster dose of the inactivated vaccine.

Clover’s COVID-19 Vaccine Candidate Demonstrates Superior Booster Responses Compared to Inactivated Vaccine

Retrieved on: 
Tuesday, September 6, 2022
European Medicines Agency, 2020 European Medicines Agency cyberattack, COVID-19, Safety, GMT T1XX platform, Vaccine, National Medical Products Administration, Infection, Aluminium, Severe acute respiratory syndrome coronavirus 2, Antibody, GLOBE, GMT, CpG, Population, Adult, World, SCB-2019, 1018, Forward-looking statement, World Health Organization, Pharmaceutical industry, Clover, Trimer, Omicron

SHANGHAI, China, Sept. 06, 2022 (GLOBE NEWSWIRE) -- Clover Biopharmaceuticals, Ltd. (Clover; HKEX: 02197), a global clinical-stage biotechnology company developing novel vaccines and biologic therapeutic candidates, today announced positive data from its ongoing Phase 3 study evaluating Clover’s SCB-2019 (CpG 1018/Alum) as a universal COVID-19 booster vaccine candidate. The preliminary data showed that SCB-2019 elicited superior levels of neutralizing antibodies against the original strain of SARS-CoV-2 and Omicron subvariants BA.1 and BA.2 when administered as a heterologous third dose in participants who previously received two doses of an inactivated vaccine compared to a third dose of the inactivated vaccine.

Key Points: 
  • A booster dose of SCB-2019 in participants who previously received two doses of the inactivated vaccine elicited superior neutralizing immune responses against the original strain and Omicron BA.1 and BA.2 compared to responses in participants receiving a third dose of the inactivated vaccine.
  • These results are part of a Phase 3, double-blind, randomized and controlled study that is evaluating the safety and immunogenicity of SCB-2019 administered as a booster dose in individuals who received two doses of inactivated vaccine compared to third, homologous booster dose of the inactivated vaccine.
  • Clover is also currently enrolling a subcohort evaluating SCB-2019 as a fourth dose booster in individuals previously receiving three doses of the inactivated vaccine compared to a fourth, homologous booster dose of the inactivated vaccine.
  • This new study data adds to the growing body of evidence evaluating SCB-2019 as a potential universal COVID-19 booster candidate.

Clover’s COVID-19 Booster Vaccine Candidate Demonstrates Robust Neutralization of Dominant Omicron BA.5

Retrieved on: 
Tuesday, August 30, 2022
LINK, European Medicines Agency, COVID-19, Public health, Vaccination, Development, GMT T1XX platform, Vaccine, National Medical Products Administration, Omicron, Coalition, Aluminium, CEPI, Severe acute respiratory syndrome coronavirus 2, GLOBE, CpG, Therapy, Population, World, Epidemic, SCB-2019, 1018, Forward-looking statement, Coalition for Epidemic Preparedness Innovations, World Health Organization, Pharmaceutical industry, Clover, Trimer

SHANGHAI, China, Aug. 30, 2022 (GLOBE NEWSWIRE) -- Clover Biopharmaceuticals, Ltd. (Clover; HKEX: 02197), a global clinical-stage biotechnology company developing novel vaccines and biologic therapeutics, today announced positive Phase 2/3 clinical trial data demonstrating that its lead COVID-19 vaccine candidate, SCB-2019 (CpG 1018/Alum), elicited a robust immune response to Omicron BA.5 subvariant, the dominant SARS-CoV-2 variant circulating globally today, building upon previously announced results for neutralization against Omicron BA.2 [LINK] and BA.1 [LINK]. This new positive data adds to the growing body of consistent evidence supporting the potential use of SCB-2019 (CpG 1018/Alum) as a universal COVID-19 booster vaccine to address the variant of SARS-CoV-2 most relevant today.

Key Points: 
  • It builds upon the full breadth of our development of SCB-2019 (CpG 1018/Alum) as a universal booster demonstrating broad neutralization against the most current Omicron lineages and all Variants of Concern to date.
  • In this Phase 2/3 trial, a homologous booster dose of SCB-2019 (CpG 1018/Alum) in individuals who previously received two doses of SCB-2019 (CpG 1018/Alum) induced a robust and rapid neutralizing antibody immune response (using validated live SARS-CoV-2 virus neutralization assays).
  • Together, this data supports the potential of SCB-2019 (CpG 1018/Alum) as a broadly neutralizing vaccine against divergent lineages of the Omicron variant.
  • Clover created its COVID-19 vaccine candidate by combining SCB-2019 with Dynavaxs (Nasdaq: DVAX) CpG 1018 advanced adjuvant and aluminum hydroxide (alum).

Clover Announces Positive Phase 2/3 Results in Adolescents for its COVID-19 Vaccine

Retrieved on: 
Thursday, August 25, 2022
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SHANGHAI, China, Aug. 25, 2022 (GLOBE NEWSWIRE) -- Clover Biopharmaceuticals, Ltd. (Clover; HKEX: 02197), a global clinical-stage biotechnology company developing novel vaccines and biologic therapeutic candidates, today announced positive data from a global Phase 2/3 trial evaluating Clover's COVID-19 vaccine candidate, SCB-2019 (CpG 1018/Alum), in adolescents (aged 12 to 17 years). The study successfully met the primary endpoint and demonstrated that vaccination with SCB-2019 (CpG 1018/Alum) elicited approximately 2-fold higher neutralizing antibody titers in adolescents compared to young adults (aged 18 to 25 years), a population where SCB-2019 (CpG 1018/Alum) had previously been demonstrated to be highly protective against COVID-19. Clover plans to submit the data and seek licensure in adolescents from global regulatory authorities, in addition to its ongoing submissions to the China National Medical Products Administration (NMPA), the European Medicines Agency (EMA), and the World Health Organization (WHO) for use in adults and elderly, to broaden the potential use of SCB-2019 (CpG 1018/Alum) across age groups and as a universal COVID-19 booster vaccine.

Key Points: 
  • We are highly encouraged by these positive pivotal Phase 2/3 trial data in adolescents.
  • The Phase 2/3 trial in adolescents enrolled 1,278 participants and evaluated the immunogenicity, safety, and efficacy of SCB-2019 (CpG 1018/Alum) vaccine, administered as 2 doses given 21 days apart.
  • These study results will contribute to the SCB-2019 (CpG 1018/Alum) data package and the licensure pathway for Clovers COVID-19 vaccine candidate in adolescents.
  • Clover created its COVID-19 vaccine candidate by combining SCB-2019 with Dynavaxs (Nasdaq: DVAX) CpG 1018 advanced adjuvant and aluminum hydroxide (alum).

Clover Announces Executive Leadership Appointments

Retrieved on: 
Friday, July 1, 2022
People, Novartis Gene Therapies, Arthur Andersen, SCB-2019, Human, Novartis, Pennsylvania State University, East China Normal University, Nielsen, CpG, Engineering, Human resources, GLOBE, COVID-19, Growth, Nike, Core business, Forward-looking statement, National Basketball Ass'n v. Motorola, Inc., BI Norwegian Business School, Shanghai Jiao Tong University, Culture, MBA, Vaccine, WeWork, General Motors, Levi Strauss & Co., Severe acute respiratory syndrome coronavirus 2, Normal school, Pharmaceutical industry, Management, Public relations, Finance, Greater China, Trimer

These appointments further strengthen Clovers global executive leadership team to drive its next phase of growth and operational success.

Key Points: 
  • These appointments further strengthen Clovers global executive leadership team to drive its next phase of growth and operational success.
  • As Clover is entering a critical phase of its growth, we are taking thoughtful steps to further strengthen our executive leadership team, said Joshua Liang, Chief Executive Officer and Executive Director of Clover.
  • Their contributions will be invaluable in guiding Clover through its transition into a global commercial-stage biotech in the coming months.
  • Prior to Clover, she was Vice President of People and Culture at WeWork Greater China, where she was part of the global executive leadership team.

Clover’s COVID-19 Vaccine Candidate Demonstrates Strong Cross-Neutralization Against Omicron as a Homologous Booster

Retrieved on: 
Monday, June 27, 2022
LinkedIn, SCB-2019, CpG, GLOBE, COVID-19, Omicron, Forward-looking statement, Development, WHO, 1018, EMA, Aluminium, Vaccine, Safety, Manuscript, Severe acute respiratory syndrome coronavirus 2, Clover, Trimer

A homologous booster dose of SCB-2019 (CpG 1018/Alum) demonstrated a significant, 19-fold increase in neutralizing antibody levels against the Omicron BA.2 variant compared to pre-booster levels among baseline seronegative participants.

Key Points: 
  • A homologous booster dose of SCB-2019 (CpG 1018/Alum) demonstrated a significant, 19-fold increase in neutralizing antibody levels against the Omicron BA.2 variant compared to pre-booster levels among baseline seronegative participants.
  • In this study, a homologous booster dose of SCB-2019 (CpG 1018/Alum) in individuals who previously received two doses of SCB-2019 (CpG 1018/Alum) induced a robust and rapid neutralizing antibody immune response in this preliminary analysis.
  • This double-blind, randomized, controlled study evaluated the immunogenicity and safety of SCB-2019 (CpG 1018/Alum) as a homologous booster dose administered approximately six months following a two-dose primary vaccination with SCB-2019 (CpG 1018/Alum).
  • Clover created its COVID-19 vaccine candidate by combining SCB-2019 with Dynavaxs (Nasdaq: DVAX) CpG 1018 advanced adjuvant and aluminum hydroxide (alum).

Clover Appoints Donna Ambrosino, M.D., and Ralf Clemens, M.D., Ph.D., to Board of Directors

Retrieved on: 
Monday, June 20, 2022
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(Clover; HKEX: 02197), a global clinical-stage biotechnology company developing novel vaccines and biologic therapeutic candidates, today announced the appointment of Donna Ambrosino, M.D., and Ralf Clemens, M.D., Ph.D., to the companys Board of Directors.

Key Points: 
  • (Clover; HKEX: 02197), a global clinical-stage biotechnology company developing novel vaccines and biologic therapeutic candidates, today announced the appointment of Donna Ambrosino, M.D., and Ralf Clemens, M.D., Ph.D., to the companys Board of Directors.
  • Dr. Ambrosino is a renowned scientific leader for vaccine development and a current member of Clovers Vaccine Scientific Advisory Board.
  • Dr. Ambrosino was also an associate professor of pediatrics at the Dana-Farber Cancer Institute and Children's Hospital,Harvard Medical School.
  • I am excited to join Clovers Board as the company continues to advance its pipeline of potentially life-saving vaccines and therapies.