COVID-19 vaccines

Moderna Announces First Participant Dosed in Phase 1/2 Study of Its Quadrivalent Seasonal Flu mRNA Vaccine

Retrieved on: 
Wednesday, July 7, 2021

Moderna, Inc. (Nasdaq: MRNA), a biotechnology company pioneering messenger RNA (mRNA) therapeutics and vaccines, today announced the first participants have been dosed in the Phase 1/2 study of mRNA-1010, the Companys quadrivalent seasonal influenza mRNA vaccine candidate.

Key Points: 
  • Moderna, Inc. (Nasdaq: MRNA), a biotechnology company pioneering messenger RNA (mRNA) therapeutics and vaccines, today announced the first participants have been dosed in the Phase 1/2 study of mRNA-1010, the Companys quadrivalent seasonal influenza mRNA vaccine candidate.
  • This Phase 1/2 randomized, stratified, observer-blind, dose-ranging study will evaluate the safety, reactogenicity and immunogenicity of mRNA-1010, Modernas seasonal influenza vaccine candidate in healthy adults 18 years and older in the U.S.
  • We are pleased to have begun this Phase 1/2 study of mRNA-1010, our first mRNA seasonal flu vaccine candidate to enter the clinic.
  • We expect that our seasonal influenza vaccine candidates will be an important component of our future combination respiratory vaccines, said Stphane Bancel, Chief Executive Officer of Moderna.

VBI Vaccines Appoints Linda Bain to Board of Directors

Retrieved on: 
Wednesday, July 7, 2021

VBI Vaccines Inc. ( Nasdaq: VBIV ) (VBI), a biopharmaceutical company driven by immunology in the pursuit of powerful prevention and treatment of disease, today announced that Linda Bain, Chief Financial Officer of Codiak BioSciences, Inc., has joined its Board of Directors.

Key Points: 
  • VBI Vaccines Inc. ( Nasdaq: VBIV ) (VBI), a biopharmaceutical company driven by immunology in the pursuit of powerful prevention and treatment of disease, today announced that Linda Bain, Chief Financial Officer of Codiak BioSciences, Inc., has joined its Board of Directors.
  • I am excited to be joining VBIs Board at such a transformational time, said Ms. Bain.
  • VBI Vaccines Inc. (VBI) is a biopharmaceutical company driven by immunology in the pursuit of powerful prevention and treatment of disease.
  • VBI is headquartered in Cambridge, Massachusetts, with research operations in Ottawa, Canada, and a research and manufacturing site in Rehovot, Israel.

Biocytogen/Eucure Biopharma's CTLA-4 and CD40 mAbs Approved for Phase II Clinical Trials by the FDA

Retrieved on: 
Tuesday, July 6, 2021

Both trials are multi-regional clinical trials, and will be conducted in the United States, Australia and China.

Key Points: 
  • Both trials are multi-regional clinical trials, and will be conducted in the United States, Australia and China.
  • The YH003 phase II clinical trial in Australia was approved by the Australian regulatory agency in May 2021 following a phase I dose-escalation study launched in May 2020.
  • "In just one year, both products advanced from Australian phase I clinical trials to the FDA approvals of phase II trials.
  • We will continue to actively promote the clinical trials of YH001 and YH003 in China and around the world.

Biocytogen/Eucure Biopharma's CTLA-4 and CD40 mAbs Approved for Phase II Clinical Trials by the FDA

Retrieved on: 
Tuesday, July 6, 2021

Both trials are multi-regional clinical trials, and will be conducted in the United States, Australia and China.

Key Points: 
  • Both trials are multi-regional clinical trials, and will be conducted in the United States, Australia and China.
  • The YH003 phase II clinical trial in Australia was approved by the Australian regulatory agency in May 2021 following a phase I dose-escalation study launched in May 2020.
  • "In just one year, both products advanced from Australian phase I clinical trials to the FDA approvals of phase II trials.
  • We will continue to actively promote the clinical trials of YH001 and YH003 in China and around the world.

Novavax to Host Conference Call to Discuss Second Quarter Financial Results and Operational Highlights on August 5, 2021

Retrieved on: 
Tuesday, July 6, 2021

The company's proprietary recombinant technology platform combines the power and speed of genetic engineering to efficiently produce highly immunogenic nanoparticles designed to address urgent global health needs.

Key Points: 
  • The company's proprietary recombinant technology platform combines the power and speed of genetic engineering to efficiently produce highly immunogenic nanoparticles designed to address urgent global health needs.
  • Novavax is conducting late-stage clinical trials for NVX-CoV2373, its vaccine candidate against SARS-CoV-2, the virus that causes COVID-19.
  • NanoFlu, its quadrivalent influenza nanoparticle vaccine, met all primary objectives in its pivotal Phase 3 clinical trial in older adults and will be advanced for regulatory submission.
  • Both vaccine candidates incorporate Novavax' proprietary saponin-based Matrix-M adjuvant to enhance the immune response and stimulate high levels of neutralizing antibodies.

Dynavax and Biological E Announce Commercial Supply Agreement of Dynavax's CpG 1018 Adjuvant for Biological E's COVID-19 Vaccine Candidate

Retrieved on: 
Tuesday, July 6, 2021

"We are pleased to collaborate with Dynavax, and our collaboration will produce yet another vital vaccine against the spread of COVID-19.

Key Points: 
  • "We are pleased to collaborate with Dynavax, and our collaboration will produce yet another vital vaccine against the spread of COVID-19.
  • Dynavax developed CpG 1018 adjuvant to provide an increased vaccine immune response, which has been demonstrated in HEPLISAV-B.
  • CpG 1018 adjuvant provides a well-developed technology and a significant safety database, potentially accelerating the development and large-scale manufacturing of a COVID-19 vaccine.
  • Dynavax is also advancing CpG 1018 adjuvant as a premier vaccine adjuvant through research collaborations and partnerships.

Government of Canada funds three new projects to encourage COVID-19 vaccination in Canada

Retrieved on: 
Monday, July 5, 2021

The Government of Canada is working closely with experts, provinces and territories, and other partners to encourage vaccine confidence and better understand the barriers people may face to getting vaccinated.

Key Points: 
  • The Government of Canada is working closely with experts, provinces and territories, and other partners to encourage vaccine confidence and better understand the barriers people may face to getting vaccinated.
  • The IPF isone tool to help people in Canada make informed vaccine choices through community mobilization and public outreach.
  • In 2020, as a response to Canada's COVID-19 vaccination efforts and building on the early momentum of the IPF, the Government of Canada invested an additional $64 million for projects to support COVID-19 vaccine uptake in Canada.
  • Women's College Hospital will receive up to $500,000 for its project Long Term Care, Homecare,Essential WorkersNational Vaccination Engagement Campaign.

Valneva to Host Symposium on COVID-19 and Chikungunya Vaccine Candidates at 31st European Congress of Clinical Microbiology & Infectious Diseases

Retrieved on: 
Monday, July 5, 2021

VLA2001 is currently the only whole virus, inactivated, adjuvanted vaccine candidate in clinical trials against COVID-19 in Europe.

Key Points: 
  • VLA2001 is currently the only whole virus, inactivated, adjuvanted vaccine candidate in clinical trials against COVID-19 in Europe.
  • VLA2001 is produced on Valnevas established Vero-cell platform, leveraging the manufacturing technology for Valnevas licensed Japanese encephalitis vaccine, IXIARO.
  • To Valnevas knowledge, VLA1553 is currently the only chikungunya vaccine candidate in Phase 3 clinical trials that targets long-term protection with a single administration.
  • In the Phase 1 clinical trial of VLA1553, Valneva observed development of antibodies to chikungunya virus resulting in 100% seroconversion of the 120 healthy participants.

Ocugen’s COVID-19 Vaccine Co-Development Partner, Bharat Biotech, Shares Phase 3 Results Demonstrating 77.8% Protection against Overall Disease

Retrieved on: 
Friday, July 2, 2021

Combining these data with the only Delta-variant results from a controlled Phase 3 clinical trial, evidence continues to support a favorable benefit-risk profile for COVAXIN, saidDr.

Key Points: 
  • Combining these data with the only Delta-variant results from a controlled Phase 3 clinical trial, evidence continues to support a favorable benefit-risk profile for COVAXIN, saidDr.
  • Bruce Forrest, Acting Chief Medical Officer and a member of the vaccine scientific advisory board ofOcugen.
  • The safety and efficacy readouts from Phase III clinical trials present a comprehensive data package for COVAXIN.
  • The acquisition of the rabies vaccine facility, Chiron Behring, from GlaxoSmithKline (GSK) has positioned Bharat Biotech as the world's largest rabies vaccine manufacturer.

Dynavax Reports Inducement Grants Under Nasdaq Listing Rule 5635(c)(4)

Retrieved on: 
Friday, July 2, 2021

The stock options were granted on July 1, 2021 at an exercise price of $10.23 per share, which is equal to the closing price of Dynavax common stock on the date of grant.

Key Points: 
  • The stock options were granted on July 1, 2021 at an exercise price of $10.23 per share, which is equal to the closing price of Dynavax common stock on the date of grant.
  • The options were granted as a material inducement to employment in accordance with Nasdaq Listing Rule 5635(c)(4) and are subject to the terms and conditions of a stock option agreement covering the grant and Dynavax' 2021 Inducement Award Plan, which was adopted January 9, 2021 and provides for the granting of stock options to new employees.
  • Dynavax is a commercial stage biopharmaceutical company developing and commercializing novel vaccines.
  • Dynavax is also advancing CpG 1018 adjuvant as a premier vaccine adjuvant through research collaborations and partnerships.