1018

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

Retrieved on: 
Wednesday, November 30, 2022
Hospital, United Nations Development Programme, Risk, Hepatitis E, Therapy, International Vaccine Institute, Severe acute respiratory syndrome coronavirus 2, Shigella, European Medicines Agency, WHO, Infection, Omicron, United Nations, Aluminium, SCB-2019, National Medical Products Administration, Transcription-mediated amplification, PQ, Development, Public health, Salmonella, Adjuvant, Fever Dream, Chikungunya, Global health, Cholera, World Health Organization, CpG, HPV, 1018, Safety, IVI, Schistosomiasis, MD, Vaccination, 2020 European Medicines Agency cyberattack, Vaccine, Pharmaceutical industry, Clover, COVID-19, Trimer

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.

Dynavax to Present at Two Upcoming Investor Conferences

Retrieved on: 
Wednesday, November 9, 2022
1018, Infection, Hepatitis B virus, Risk, SEC, Plague, Company, DPT vaccine, Vaccine, Adjuvant, Union, Securities Exchange Act of 1934, Securities Act of 1933, Program, Forward-looking statement, CpG, COVID-19, Nasdaq, Research, Shingles, Time

Dynavax is advancing CpG 1018 adjuvant as a premier vaccine adjuvant through global research collaborations and partnerships.

Key Points: 
  • Dynavax is advancing CpG 1018 adjuvant as a premier vaccine adjuvant through global research collaborations and partnerships.
  • Current collaborations are focused on adjuvanted vaccines for COVID-19, seasonal influenza, universal influenza, plague, shingles and Tdap.
  • For more information about our marketed products and development pipeline, visit www.dynavax.com and follow Dynavax on LinkedIn .
  • All forward-looking statements in this document are qualified in their entirety by this cautionary statement.

Dynavax to Report Third Quarter Financial Results and Host Conference Call on November 3, 2022

Retrieved on: 
Thursday, October 20, 2022
LinkedIn, Union, Webcast, Plague, Infection, Vaccine, DPT vaccine, Shingles, Research, Nasdaq, Hepatitis B virus, Company, CpG, COVID-19, 1018, Adjuvant

EMERYVILLE, Calif., Oct. 20, 2022 /PRNewswire/ -- Dynavax Technologies Corporation (Nasdaq: DVAX), a commercial stage biopharmaceutical company developing and commercializing innovative vaccines, will report third quarter financial results on Thursday, November 3, 2022, after the U.S. financial markets close.

Key Points: 
  • EMERYVILLE, Calif., Oct. 20, 2022 /PRNewswire/ -- Dynavax Technologies Corporation (Nasdaq: DVAX), a commercial stage biopharmaceutical company developing and commercializing innovative vaccines, will report third quarter financial results on Thursday, November 3, 2022, after the U.S. financial markets close.
  • Dynavax will host a conference call and live audio webcast on Thursday, November 3, 2022, at 4:30 p.m. (ET)/1:30 p.m. (PT).
  • The live audio webcast may be accessed through the "Events & Presentations" page on the "Investors" section of the Company's website at https://investors.dynavax.com/events-presentations .
  • For more information about our marketed products and development pipeline, visit www.dynavax.com and follow Dynavax on LinkedIn .

Dynavax to Present at the H.C. Wainwright 3rd Annual Hepatitis B Virus Virtual Conference

Retrieved on: 
Friday, October 14, 2022
LinkedIn, Union, Plague, Conference, Infection, Vaccine, DPT vaccine, Shingles, Research, Nasdaq, Hepatitis B virus, Company, CpG, COVID-19, 1018, Adjuvant, Pharmaceutical industry

Dynavax is a commercial-stage biopharmaceutical company developing and commercializing innovative vaccines to help protect the world against infectious diseases.

Key Points: 
  • Dynavax is a commercial-stage biopharmaceutical company developing and commercializing innovative vaccines to help protect the world against infectious diseases.
  • Dynavax is advancing CpG 1018 adjuvant as a premier vaccine adjuvant through global research collaborations and partnerships.
  • Current collaborations are focused on adjuvanted vaccines for COVID-19, seasonal influenza, universal influenza, plague, shingles and Tdap.
  • For more information about our marketed products and development pipeline, visit www.dynavax.com and follow Dynavax on LinkedIn .

Clover Provides Update on 2022 Corporate Milestones

Retrieved on: 
Sunday, October 9, 2022
2020 European Medicines Agency cyberattack, Therapy, Efficiency, EMA, FleetBoston Financial, CBLA-FM, APA, LINK, Adolescence, European Medicines Agency, Safety, European Union response to the COVID-19 pandemic, NMPA, CAS-1, China Merchants Bank, Severe acute respiratory syndrome coronavirus 2, WHO, CDMO, CpG, World Health Organization, GLOBE, SCB-2019, Hospital, Development, Vaccine, National Medical Products Administration, Research, Aluminium, Technology, Ageing, Vaccination, World, 1018, Omicron, GMP, Profile, Business, US, Business development, Rabies, Forward-looking statement, COVID-19, Pharmaceutical industry, Trimer, Clover, EU

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.

Valneva Provides Further Update on its COVID-19 Activities

Retrieved on: 
Monday, September 26, 2022
Lyme disease, COVID-19, 1018, World, Severe acute respiratory syndrome coronavirus 2, World Health Organization, Vaccination, Company, VLA, Vero, EU, Technology, Vaccine, Nasdaq, Chikungunya, WHO, VLA2001, Marketing, CpG, Saint-Herblain, Euronext Paris, EMA, Infection, Pharmaceutical industry, Kingdom

Saint-Herblain (France), September 26, 2022 Valneva SE (Nasdaq: VALN; Euronext Paris: VLA), a specialty vaccine company, today announced a further update on its COVID-19 vaccine activities.

Key Points: 
  • Saint-Herblain (France), September 26, 2022 Valneva SE (Nasdaq: VALN; Euronext Paris: VLA), a specialty vaccine company, today announced a further update on its COVID-19 vaccine activities.
  • The Company is in active discussions with a prospective partner for potentially funding the development of a second-generation COVID-19 vaccine.
  • Valneva currently has agreements to supply VLA2001 to certain EU Member States2 and the Kingdom of Bahrain6.
  • Valneva is a specialty vaccine company focused on the development and commercialization of prophylactic vaccines for infectious diseases with significant unmet medical need.

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
Adult, Aluminium, Therapy, Safety, Development, SCB-2019, COVID-19, 1018, 2020 European Medicines Agency cyberattack, World, Severe acute respiratory syndrome coronavirus 2, World Health Organization, National Medical Products Administration, Vaccination, GMT T1XX platform, Forward-looking statement, History, LINK, Vaccine, Omicron, European Medicines Agency, GLOBE, CpG, Pharmaceutical industry, Clover, Trimer

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.

Valneva and IDT Biologika Agree on Termination of their COVID-19 Collaboration

Retrieved on: 
Friday, September 16, 2022
Lyme disease, COVID-19, 1018, World, Severe acute respiratory syndrome coronavirus 2, World Health Organization, Vaccination, European Commission, Company, IDT Corporation, VLA, Vero, EU, History, Biosafety level, Technology, Vaccine, Nasdaq, IDT, Chikungunya, WHO, VLA2001, Marketing, CpG, Saint-Herblain, Euronext Paris, EMA, Infection, Kingdom

As per the commercial manufacturing services agreement signed in November 20211, IDT Biologika produced VLA2001 bulk vaccine at its Biosafety Level 3 facilities in Germany, and Valneva bought the batches that were manufactured so far by IDT.

Key Points: 
  • As per the commercial manufacturing services agreement signed in November 20211, IDT Biologika produced VLA2001 bulk vaccine at its Biosafety Level 3 facilities in Germany, and Valneva bought the batches that were manufactured so far by IDT.
  • Valneva is a specialty vaccine company focused on the development and commercialization of prophylactic vaccines for infectious diseases with significant unmet medical need.
  • IDT Biologika is an innovative biotech company with a successful history dating back 100 years.
  • In the US, the IDT Corporation has a manufacturing site for clinical test samples in Rockville, Maryland.

Dynavax to Present at the H.C. Wainwright 24th Annual Global Investment Conference

Retrieved on: 
Thursday, September 8, 2022
COVID-19, DPT vaccine, Research, Hepatitis B virus, Shingles, Vaccine, Infection, Adjuvant, LinkedIn, Union, Plague, CpG, Conference, Nasdaq, Company, 1018

The on demand presentation will be available, beginning Monday, September 12, 2022 at 7:00 a.m. E.T.

Key Points: 
  • The on demand presentation will be available, beginning Monday, September 12, 2022 at 7:00 a.m. E.T.
  • and may be accessed through the "Events & Presentations" page on the "Investors" section of the Company's website at https://investors.dynavax.com/events-presentations .
  • Dynavax is a commercial-stage biopharmaceutical company developing and commercializing innovative vaccines to help protect the world against infectious diseases.
  • Dynavax is advancing CpG 1018 adjuvant as a premier vaccine adjuvant through global research collaborations and partnerships.