DVAX Dynavax Technologies Corporation

5.13
-0.01  -0%
Previous Close 5.14
Open 5.15
52 Week Low 1.8
52 Week High 12.44
Market Cap $565,186,767
Shares 110,172,859
Float 82,427,096
Enterprise Value $606,426,766
Volume 3,676,005
Av. Daily Volume 2,976,400
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Upcoming Catalysts

Drug Stage Catalyst Date
Medigen with CpG 1018
COVID-19 vaccine
Phase 1
Phase 1
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Biological E. vaccine with CpG 1018
COVID-19 vaccine
Phase 1/2
Phase 1/2
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Drug Pipeline

Drug Stage Notes
S-Trimer COVID-19 Vaccine + CpG 1018 adjuvant plus alum
COVID-19 vaccine
Phase 1
Phase 1
Phase 2/3 trial is planned for 1H 2021.
HEPLISAV-B
End Stage Renal Disease on Dialysis undergoing hemodialysis
Phase 1
Phase 1
Phase 1 interim safety data released January 7, 2021 - well tolerated; no safety concerns were observed.
AZD1419
Asthma
Phase 2a
Phase 2a
Phase 2a trial did not meet primary endpoint - November 29, 2018.
HEPLISAV-B
Hepatitis B
Approved
Approved
CRL February 25, 2013 and November 14, 2016. Advisory Committee Meeting July 28, 2017 voted 21 -1 in favor of recommending approval. Final approval announced November 9, 2017.

Latest News

  1. EMERYVILLE, Calif., Jan. 7, 2021 /PRNewswire/ -- Dynavax Technologies Corporation (NASDAQ:DVAX), a biopharmaceutical company focused on developing and commercializing vaccines, today announced final immunogenicity and interim safety results of the ongoing clinical trial evaluating HEPLISAV-B® [Hepatitis B Vaccine (Recombinant), Adjuvanted] in patients undergoing hemodialysis.

    Final immunogenicity data in 119 patients in this clinical trial evaluating a 4-dose regimen of HEPLISAV-B in adults with end-stage renal disease (ESRD) undergoing hemodialysis, demonstrated a seroprotection rate of 89.3% with high levels of anti-HBs antibodies, which are critical to maintain protection in patients undergoing hemodialysis. Interim safety data showed HEPLISAV-B is well tolerated and no safety concerns were observed. Full safety data are expected by the end of 2021.

    "We are pleased with these positive results from the ongoing hemodialysis trial which reinforce the existing clinical data regarding the safety and ability of HEPLISAV-B to provide high rates of protection," commented Robert Janssen, MD, Chief Medical Officer at Dynavax. "We believe the 4-dose regimen of HEPLISAV-B, we are evaluating in this study, can provide an important hepatitis B vaccination alternative for patients undergoing hemodialysis by delivering high levels of protection with fewer doses compared to the current standard of care which requires up to 8 injections to complete the regimen."

    The study, HBV-24, is an ongoing, open-label, single-arm trial being conducted in the United States to evaluate a new 4-dose regimen of HEPLISAV-B in adults with ESRD who are undergoing hemodialysis and have not previously received a hepatitis B vaccine. The study is designed to evaluate the immunogenicity of HEPLISAV-B at study week 20 and safety over the 68-week study duration. Safety and effectiveness of HEPLISAV-B have not been established in adults on hemodialysis.

    Please see Important Safety Information below.

    For more information about HEPLISAV-B, visit http://heplisavb.com

    About Hepatitis B

    Hepatitis B is a viral disease of the liver that can become chronic and lead to cirrhosis, liver cancer and death. The hepatitis B virus is 50 to 100 times more infectious than HIV,i and transmission is on the rise. There is no cure for hepatitis B, but effective vaccination can prevent the disease.

    In adults, hepatitis B is spread through contact with infected blood and through unprotected sex with an infected person. The U.S. Centers for Disease Control (CDC) recommends vaccination for those at high risk for infection due to their jobs, lifestyle, living situations and travel to certain areas.ii Because people with diabetes are particularly vulnerable to infection, the CDC recommends vaccination for adults age 19 to 59 with diabetes as soon as possible after their diagnosis, and for people age 60 and older with diabetes at their physician's discretion.iii Approximately 20 million U.S. adults have diabetes, and 1.5 million new cases of diabetes are diagnosed each year.iv

    About HEPLISAV-B

    HEPLISAV-B is an adult hepatitis B vaccine that combines hepatitis B surface antigen with Dynavax's proprietary Toll-like Receptor (TLR) 9 agonist adjuvant CpG 1018 to enhance the immune response. Dynavax has worldwide commercial rights to HEPLISAV-B.

    Indication and Use

    HEPLISAV-B is indicated for prevention of infection caused by all known subtypes of hepatitis B virus in adults age 18 years and older.

    Important Safety Information (ISI)

    Do not administer HEPLISAV-B to individuals with a history of severe allergic reaction (e.g., anaphylaxis) after a previous dose of any hepatitis B vaccine or to any component of HEPLISAV-B, including yeast. Appropriate medical treatment and supervision must be available to manage possible anaphylactic reactions following administration of HEPLISAV-B.

    Immunocompromised persons, including individuals receiving immunosuppressant therapy, may have a diminished immune response to HEPLISAV-B.

    Hepatitis B has a long incubation period. HEPLISAV-B may not prevent hepatitis B infection in individuals who have an unrecognized hepatitis B infection at the time of vaccine administration.

    The most common patient reported adverse reactions reported within 7 days of vaccination were injection site pain (23% to 39%), fatigue (11% to 17%) and headache (8% to 17%).

    For full Prescribing Information for HEPLISAV-B, click here

    About Dynavax

    Dynavax is a commercial stage biopharmaceutical company developing and commercializing novel vaccines. The Company's first commercial product, HEPLISAV-B® [Hepatitis B Vaccine (Recombinant), Adjuvanted], is approved in the U.S. for prevention of infection caused by all known subtypes of hepatitis B virus in adults age 18 years and older. Dynavax is also advancing CpG 1018 as a premier vaccine adjuvant through research collaborations and partnerships. Current collaborations are focused on adjuvanted vaccines for COVID-19, pertussis and universal influenza. For more information, visit www.dynavax.com and follow the company on LinkedIn.

    Forward-Looking Statements

    This press release contains forward-looking statements, including statements regarding use of HEPLISAV-B in adults undergoing hemodialysis.   These statements are subject to a number of risks and uncertainties that could cause actual results to differ materially, including whether and when the clinical study will be completed and what the final results will reflect, and whether additional studies will be required to demonstrate safety and effectiveness of HEPLISAV-B in person's undergoing hemodialysis, and if further studies are required, when they would be completed and what the results will reflect. For a further description of the risks and uncertainties that could cause actual results to differ from those expressed in these forward-looking statements, as well as risks relating to the business of Dynavax in general, see risks detailed in the "Risk Factors" section of our most recent current periodic report filed with the SEC. These statements represent our estimates and assumptions only as of the date of this press release. We do not undertake any obligation to update publicly any such forward-looking statements, even if new information becomes available. Information on Dynavax's website at www.dynavax.com is not incorporated by reference in our current periodic reports with the SEC

    Contacts:

    Nicole Arndt, Senior Manager, Investor Relations



    510-665-7264

    Derek Cole, President

    Investor Relations Advisory Solutions

     

    i CDC. https://www.cdc.gov/hepatitis/hbv/bfaq.htm.

    ii CDC. https://www.cdc.gov/hepatitis/hbv/hbvfaq.htm.

    iii CDC. https://www.cdc.gov/diabetes/pubs/pdf/hepb_vaccination.pdf.

    iv CDC. https://www.cdc.gov/diabetes/pdfs/data/statistics/national-diabetes-statistics-report.pdf.

     

    Cision View original content to download multimedia:http://www.prnewswire.com/news-releases/dynavax-announces-final-immunogenicity-and-interim-safety-results-from-clinical-trial-evaluating-heplisav-b-in-patients-undergoing-hemodialysis-301202453.html

    SOURCE Dynavax Technologies

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  2. EMERYVILLE, Calif., Jan. 6, 2021 /PRNewswire/ -- Dynavax Technologies Corporation (NASDAQ:DVAX), a biopharmaceutical company focused on developing and commercializing vaccines, today announced that Ryan Spencer, Chief Executive Officer, will present at the H.C. Wainwright Virtual BioConnect 2021 Conference being held January 11-14, 2021.

    The on demand presentation will be available, beginning Monday, January 11, 2021 at 6:00 a.m. E.T. and may be accessed through the "Events & Presentations" page on the "Investors" section of the Company's website at http://investors.dynavax.com/events-presentations.

    About Dynavax

    Dynavax is a commercial stage biopharmaceutical company developing and commercializing novel vaccines. The Company's first commercial product, HEPLISAV-B® [Hepatitis B Vaccine (Recombinant), Adjuvanted], is approved in the U.S. for prevention of infection caused by all known subtypes of hepatitis B virus in adults age 18 years and older. Dynavax is also advancing CpG 1018 as a premier vaccine adjuvant through research collaborations and partnerships. Current collaborations are focused on adjuvanted vaccines for COVID-19, pertussis and universal influenza. For more information, visit www.dynavax.com and follow the company on LinkedIn.

    Contacts:

    Nicole Arndt



    510-665-7264

    Derek Cole, President

    Investor Relations Advisory Solutions

     

    Cision View original content to download multimedia:http://www.prnewswire.com/news-releases/dynavax-to-present-at-the-hc-wainwright-virtual-bioconnect-2021-conference-301202218.html

    SOURCE Dynavax Technologies

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  3. PUNE, India and EMERYVILLE, Calif., Dec. 23, 2020 /PRNewswire/ -- Further strengthening its fight against COVID-19, Serum Institute of India (SIIPL), the world's largest vaccine manufacturer by volume, has partnered with Dynavax Technologies Corporation (NASDAQ:DVAX) a biopharmaceutical company focused on developing and commercializing novel vaccines, and today jointly announced that the first participants have been dosed in the Phase 1 part of the Phase 1/2 clinical trial evaluating SIIPL's vaccine candidate adjuvanted with CpG 1018 to prevent COVID-19.

    The Phase 1/2 clinical trial will evaluate the safety and immunogenicity of SIIPL's vaccine candidate consisting of the SARS-COV-2 virus receptor binding domain (RBD) delivered as a virus-like particle (VPL), along with Dynavax's advanced adjuvant CpG 1018 plus alum. The Phase 1 portion of the clinical trial will enroll 39 healthy volunteers and post the completion of the study a decision will be taken regarding the dosing of up to 216 subjects in Phase 2.

    Sharing his thoughtsAdar Poonawalla, Chief Executive Officer, Serum Institute of India, said, "The collaboration with Dynavax is our effort in developing and exploring avenues to bolster our fight against the pandemic. We are hopeful that delivering the CpG 1018 adjuvant in the vaccine will enhance the immune response of the candidate. Through this we seek to provide our expertise and capability to produce large quantities of affordable vaccine to supply global needs."

    Ryan Spencer, Chief Executive Officer, Dynavax commented, "We are pleased to be partnering with Serum Institute of India to advance their approach to leverage a VLP utilizing the receptor binding domain of the SARS-COV-2 spike protein. We believe continued development of multiple programs is critical to ensure the availability of safe and effective vaccines that can protect the global population from this devastating disease in the near term and for years to come."

    About Serum Institute of India Pvt. Ltd. (SIIPL):

    Driven by the philanthropic philosophy of affordable vaccines, Serum Institute of India Pvt, Ltd. (SIIPL) is the world's largest vaccine manufacturer by number of doses produced and sold globally (more than 1.5 billion doses), supplying the world's cheapest and WHO accredited vaccines to as many as 170 countries. It was founded in 1966 with the aim of manufacturing lifesaving immunobiological drugs including vaccines worldwide. With a strong commitment towards global health, the institute's objective has been proliferated by bringing down the prices of newer vaccines such as such as Diphtheria, Tetanus, Pertussis, Hib, BCG, r-Hepatitis B, Measles, Mumps and Rubella vaccines. SII is credited with bringing world-class technology to India, through its state-of-the-art equipped multifunctional production facility in Manjri, Pune; association with Zipline and government agencies to transform emergency medicine and critical care along with spearheading the race of vaccine development against the COVID-19 pandemic.

    About CpG 1018

    CpG 1018 is the adjuvant used in HEPLISAV-B® [Hepatitis B Vaccine (Recombinant), Adjuvanted], an adult hepatitis B vaccine approved by the U.S. Food and Drug Administration (FDA). Dynavax developed CpG 1018 to provide an increased vaccine immune response, which has been demonstrated in HEPLISAV-B. CpG 1018 provides a well-developed technology and a significant safety database, potentially accelerating the development and large-scale manufacturing of a COVID-19 vaccine.

    About Dynavax

    Dynavax is a commercial stage biopharmaceutical company developing and commercializing novel vaccines. The Company's first commercial product, HEPLISAV-B® [Hepatitis B Vaccine (Recombinant), Adjuvanted], is approved in the U.S. for prevention of infection caused by all known subtypes of hepatitis B virus in adults age 18 years and older. Dynavax is also advancing CpG 1018 as a premier vaccine adjuvant through research collaborations and partnerships. Current collaborations are focused on adjuvanted vaccines for COVID-19, pertussis and universal influenza. For more information, visit www.dynavax.com and follow the company on LinkedIn.

    Dynavax Forward-Looking Statements

    This press release contains "forward-looking" statements, including statements regarding the potential to develop a COVID-19 vaccine containing CpG 1018.  Actual results may differ materially from those set forth in this press release due to the risks and uncertainties inherent in vaccine research and development, including the timing of completing development, whether CpG 1018 combined with the Serum's antigen vaccine candidate will prove to be beneficial in clinical trials, whether use of CpG 1018 in the vaccine will enhance the immune response and help accelerate the development and large scale manufacturing of a COVID-19 vaccine, whether and when the vaccine will be approved for use, and whether sufficient quantities of CpG 1018 and of vaccine will be able to be manufactured, as well as other risks detailed in the "Risk Factors" section of our Annual Report on Form 10-K for the fiscal year ended December 31, 2019, as well as discussions of potential risks, uncertainties and other important factors in our other filings with the U.S. Securities and Exchange Commission. We undertake no obligation to revise or update information herein to reflect events or circumstances in the future, even if new information becomes available. Information on Dynavax's website at www.dynavax.com is not incorporated by reference in our current periodic reports with the SEC.

    For more details please contact:

    Dynavax Contacts

    Nicole Arndt, Senior Manager, Investor Relations



    510-665-7264

    Derek Cole, President

    Investor Relations Advisory Solutions

    SIIPL

    Mayank Sen



    +919867974055

     

    Cision View original content to download multimedia:http://www.prnewswire.com/news-releases/serum-institute-of-india-and-dynavax-announce-first-participants-dosed-in-the-phase-12-clinical-trial-for-a-covid-19-vaccine-301197984.html

    SOURCE Dynavax Technologies

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  4. EMERYVILLE, Calif., Dec. 10, 2020 /PRNewswire/ -- Dynavax Technologies Corporation (NASDAQ:DVAX), a biopharmaceutical company focused on developing and commercializing novel vaccines, today announced that the European Medicines Agency (EMA) Committee for Medicinal Products for Human Use (CHMP) has issued a positive opinion on the company's Marketing Authorization Application, recommending the granting of marketing authorization for HEPLISAV-B [Hepatitis B Vaccine (Recombinant), Adjuvanted] for the active immunization against hepatitis B virus infection (HBV) caused by all known subtypes of hepatitis B virus in adults 18 years of age and older. The CHMP recommendation was based on the assessment of HEPLISAV-B demonstrated by the safety and immunogenicity…

    EMERYVILLE, Calif., Dec. 10, 2020 /PRNewswire/ -- Dynavax Technologies Corporation (NASDAQ:DVAX), a biopharmaceutical company focused on developing and commercializing novel vaccines, today announced that the European Medicines Agency (EMA) Committee for Medicinal Products for Human Use (CHMP) has issued a positive opinion on the company's Marketing Authorization Application, recommending the granting of marketing authorization for HEPLISAV-B [Hepatitis B Vaccine (Recombinant), Adjuvanted] for the active immunization against hepatitis B virus infection (HBV) caused by all known subtypes of hepatitis B virus in adults 18 years of age and older. The CHMP recommendation was based on the assessment of HEPLISAV-B demonstrated by the safety and immunogenicity results from three Phase 3 clinical trials and post-marketing safety results.

    "Hepatitis B is a highly infectious and potentially deadly virus with increasing infection rates, and over 250 million people infected worldwide. Thankfully, it can be prevented with effective vaccination," commented Ryan Spencer, Chief Executive Officer of Dynavax. "With a regimen of only two doses in just one-month, HEPLISAV-B provides a unique opportunity to address known challenges with patient compliance, while delivering faster and higher rates of seroprotection compared to the three dose regimen over 6 months for the comparator vaccine. The positive CHMP opinion is an important step to extending the benefits of HEPLISAV-B beyond the United States, where it was approved in 2017."

    In the European Union (EU), HEPLISAV-B is not yet approved. Under the EU regulatory process, the European Commission will now review the CHMP recommendation and the final decision on Marketing Authorization is expected in the first quarter of 2021. If approved by the European Commission, Dynavax would receive marketing authorization for HEPLISAV-B in all EU Member States.

    Please see Important Safety Information below.

    About Hepatitis B

    Hepatitis B is a viral disease of the liver that can become chronic and lead to cirrhosis, liver cancer and death. The hepatitis B virus is 50 to 100 times more infectious than HIV, and transmission is on the rise. There is no cure for hepatitis B, but effective vaccination can prevent the disease.  In adults, hepatitis B is spread through contact with infected blood and through unprotected sex with an infected person.

    About HEPLISAV-B® [Hepatitis B Vaccine (Recombinant), Adjuvanted]

    HEPLISAV-B is an adult hepatitis B vaccine that combines hepatitis B surface antigen with Dynavax's proprietary Toll-like Receptor (TLR) 9 agonist CpG 1018 to enhance the immune response. Dynavax has worldwide commercial rights to HEPLISAV-B.

    Indication and Use in Approved U.S. Label

    HEPLISAV-B is indicated for prevention of infection caused by all known subtypes of hepatitis B virus in adults age 18 years and older.

    For full U.S. Prescribing Information for HEPLISAV-B, click here.

    Important Safety Information (ISI)

    Do not administer HEPLISAV-B to individuals with a history of severe allergic reaction (e.g., anaphylaxis) after a previous dose of any hepatitis B vaccine or to any component of HEPLISAV-B, including yeast. Appropriate medical treatment and supervision must be available to manage possible anaphylactic reactions following administration of HEPLISAV-B. Immunocompromised persons, including individuals receiving immunosuppressant therapy, may have a diminished immune response to HEPLISAV-B. Hepatitis B has a long incubation period. HEPLISAV-B may not prevent hepatitis B infection in individuals who have an unrecognized hepatitis B infection at the time of vaccine administration. The most common patient reported adverse reactions reported within 7 days of vaccination were injection site pain (23% to 39%), fatigue (11% to 17%) and headache (8% to 17%).

    About Dynavax

    Dynavax is a commercial stage biopharmaceutical company developing and commercializing novel vaccines. The Company's first commercial product, HEPLISAV-B® [Hepatitis B Vaccine (Recombinant), Adjuvanted], is approved in the U.S. for prevention of infection caused by all known subtypes of hepatitis B virus in adults age 18 years and older. Dynavax is also advancing CpG 1018 as a premier vaccine adjuvant through research collaborations and partnerships. Current collaborations are focused on adjuvanted vaccines for COVID-19, pertussis and universal influenza. For more information, visit www.dynavax.com and follow the company on LinkedIn.

    Forward-Looking Statements

    This press release contains "forward-looking" statements, including statements regarding the potential for HEPLISAV-B to be approved for marketing in the EU in the first quarter of 2021.  Actual results may differ materially from those set forth in this press release due to the risks and uncertainties inherent in our business, including, whether and when HEPLISAV-B will be approved for marketing in the EU, and if approved, whether we will successfully commercialize it in the EU, as well as other risks detailed in the "Risk Factors" section of our Annual Report on Form 10-K for the fiscal year ended December 31, 2019, as well as discussions of potential risks, uncertainties and other important factors in our other filings with the U.S. Securities and Exchange Commission. We undertake no obligation to revise or update information herein to reflect events or circumstances in the future, even if new information becomes available. Information on Dynavax's website at www.dynavax.com is not incorporated by reference in our current periodic reports with the SEC.

    In the EU, HEPLISAV-B is investigational and not approved. Its efficacy and safety have not been established. More information about clinical trials with HEPLISAV-B is available at www.clinicaltrials.gov.

    Contacts:

    Nicole Arndt, Senior Manager, Investor Relations



    510-665-7264

    Derek Cole, President

    Investor Relations Advisory Solutions

     

    Cision View original content to download multimedia:http://www.prnewswire.com/news-releases/european-chmp-adopts-positive-opinion-for-heplisav-b-dynavaxs-two-dose-adult-hepatitis-b-adjuvanted-vaccine-301190681.html

    SOURCE Dynavax Technologies

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    • Clover's protein-based COVID-19 vaccine candidates adjuvanted with either GSK's pandemic adjuvant system or Dynavax's CpG 1018 plus alum induced strong neutralizing immune responses in 150 adult and elderly subjects from the Phase 1 clinical study.
    • Clover's vaccine candidates both demonstrated a favorable safety and tolerability profile, and have also shown long-term stability at 2-8oC, making them suitable for global distribution.
    • A global phase 2/3 trial evaluating the safety and efficacy of the S-Trimer vaccine candidate in combination with GSK's pandemic adjuvant system is expected to begin in December 2020 funded by the Coalition for Epidemic Preparedness Innovations (CEPI).
    • A separate pivotal Phase 2/3 clinical trial of the S-Trimer
    • Clover's protein-based COVID-19 vaccine candidates adjuvanted with either GSK's pandemic adjuvant system or Dynavax's CpG 1018 plus alum induced strong neutralizing immune responses in 150 adult and elderly subjects from the Phase 1 clinical study.
    • Clover's vaccine candidates both demonstrated a favorable safety and tolerability profile, and have also shown long-term stability at 2-8oC, making them suitable for global distribution.
    • A global phase 2/3 trial evaluating the safety and efficacy of the S-Trimer vaccine candidate in combination with GSK's pandemic adjuvant system is expected to begin in December 2020 funded by the Coalition for Epidemic Preparedness Innovations (CEPI).
    • A separate pivotal Phase 2/3 clinical trial of the S-Trimer vaccine candidate in combination with Dynavax's advanced CpG 1018 adjuvant plus alum is intended to start in the first half of 2021 to maximize the potential supply of more than 1 billion doses of Clover's COVID-19 vaccines to the world.

    Clover Biopharmaceuticals, a global clinical-stage biotechnology company committed to developing transformative biologics as vaccines and therapeutics for the world's most debilitating diseases, today announced positive clinical data from its Phase 1 trial demonstrating that its protein-based COVID-19 S-Trimer vaccine candidates in combination with adjuvants from either GSK (London Stock Exchange: GSK) or Dynavax (NASDAQ:DVAX) induces strong immune responses, including neutralizing antibodies and cell-mediated immunity, as well as favorable safety and tolerability profiles in 150 adult and elderly participants. The manuscript describing the detailed results will be accessible on an online preprint server shortly.

    The Phase 1 trial was a randomized, observer-blind, placebo-controlled study to assess the safety, reactogenicity and immunogenicity of the adjuvanted COVID-19 S-Trimer vaccine candidates formulated with different antigen levels. No serious adverse events related to the vaccine candidates studied were reported. The majority of adverse events were mild and transient. S-Trimer adjuvanted with GSK's pandemic adjuvant system induced neutralizing antibody titers (seroconversion) in 100% of participants at the selected 9 µg S-Trimer dose in both adult and elderly groups, with geometric mean titers (GMT) greater than 1:1,800. CpG-1018/alum-adjuvanted S-Trimer induced neutralizing antibodies in 100% of adult participants at the selected 30 µg S-Trimer dose with GMT greater than 1:1,000, and seroconversion was observed in 88% (7 out of 8) in elderly. Strong Th1 cell-mediated immune responses were also observed for the vaccine candidates with either adjuvant.

    Preliminary results from stability studies have demonstrated that S-Trimer is stable at 2-8o C for at least six months (longer-term stability studies are ongoing) and stable at room temperature and 40o C for at least one month, in line with the adjuvants tested. Thus, the ability of Clover's COVID-19 vaccine candidates to be stored in standard refrigeration temperatures makes them suitable for broad global distribution based on current results.

    Based on the positive Phase 1 results reported and the unprecedented need for COVID-19 vaccines, Clover and its partners are confident to enter late-stage clinical development for both adjuvanted vaccines. A global Phase 2/3 efficacy study of the S-Trimer vaccine candidate in combination with GSK's pandemic adjuvant system is expected to begin in December 2020. Clover intends to initiate a separate pivotal clinical trial of the S-Trimer vaccine candidate in combination with Dynavax's advanced CpG 1018 adjuvant plus alum in the first half of 2021.

    Joshua Liang, Chief Executive Officer of Clover Biopharmaceuticals, said, "With positive results from our Phase 1 clinical trial demonstrating strong neutralizing immune responses and favorable safety profiles, we look forward to moving our COVID-19 vaccines into the final stages of clinical development. Combined with our ability to potentially produce more than one billion doses of antigen annually and the stability of our vaccines under standard refrigeration conditions, our adjuvanted COVID-19 S-Trimer vaccines are positioned to be well-suited for worldwide distribution. We and our collaborators are steadfast in our commitment to the development of safe, effective and accessible COVID-19 vaccines for the global population."

    Thomas Breuer, Chief Medical Officer of GSK Vaccines, commented, "We are delighted by the promising Phase 1 clinical data underscoring the robust and rapid immune response elicited by GSK's pandemic adjuvant system combined with Clover's antigen - in both, adults and older adults and are looking forward to demonstrate the public health value in the upcoming efficacy trial. These results – in addition to results from the combination of our adjuvant with other COVID-19 vaccine technologies - show GSK's commitment to provide scalable solutions to tackle the pandemic around the globe."

    Rob Janssen, Chief Medical Officer of Dynavax, commented, "We are pleased with the strong immune responses and an outstanding safety profile of Clover's S-Trimer vaccine adjuvanted with Dynavax's advanced CpG 1018 adjuvant plus alum. We are encouraged by the high level of neutralizing antibodies in combination with the strong Th1 response which we believe could play an important role in controlling infection. We are proud to be partnered with Clover in our endeavors to develop a safe and effective COVID-19 vaccine that will be readily accessible around the world to combat this ongoing pandemic."

    The Phase 1 clinical trial was funded by the Coalition for Epidemic Preparedness Innovations (CEPI). "This is very promising Phase 1 data which warrants further clinical development of Clover's S-Trimer vaccine candidate, " Dr. Richard Hatchett, Chief Executive Officer of CEPI commented, "This vaccine candidate has the potential to be manufactured at scale and stored in a regular refrigerator which makes it suitable for use around the globe, including in low-resource settings. Through our partnership with Clover we hope to make hundreds of millions of doses of this vaccine globally accessible through COVAX, if it is proven to be safe and effective."

    About COVID-19 S-Trimer Vaccine

    Utilizing Clover's proprietary Trimer-Tag© technology, S-Trimer is a trimeric SARS-CoV-2 spike (S)-protein subunit vaccine candidate. Similar to other enveloped RNA viruses such as HIV, RSV and Influenza, SARS-CoV-2 is also an RNA virus that has a trimeric spike (S) protein on its viral envelope. The trimeric S protein of SARS-CoV-2 is responsible for binding to host cell surface receptor ACE2 and subsequent viral entry, making it the primary target antigen for vaccine development. S-Trimer resembles the native trimeric viral spike protein and is produced via a rapid mammalian cell-culture based expression system. S-Trimer is intended to be adjuvanted.

    About Trimer-Tag© Technology

    Trimer-Tag© is an innovative drug development platform which allows the production of novel, covalently-trimerized fusion proteins. Many major disease targets are trimerization-dependent such as the tumor necrosis factor (TNF) superfamily (involved in extrinsic apoptosis, immune co-stimulation and inflammation) as well as enveloped RNA virus antigens responsible for entry into host cells. Clover is using its Trimer-Tag© technology with global IP position to develop recombinant trimerized fusion proteins that are able to effectively target these previously undruggable pathways.

    About Clover Biopharmaceuticals

    Clover Biopharmaceuticals is a global, clinical-stage, research-based biotechnology company focused on discovering, developing and commercializing transformative biologic therapies, with a focus on oncology and autoimmune diseases, as well as viral vaccines. Having raised more than USD $350 million in total capital since 2016, Clover is utilizing its proprietary Trimer-Tag© technology platform to develop novel biologics targeting trimerization-dependent pathways. Additionally, Clover is leveraging its in-house GMP biomanufacturing capabilities to support large-scale production of its biologic therapies. For more information, please visit our website:  www.cloverbiopharma.com.

    About GSK

    GSK is a science-led global healthcare company with a special purpose: to help people do more, feel better, live longer. GSK is the leading manufacturer of vaccines globally. For further information please visit https://www.gsk.com/en-gb/about-us/

    About Dynavax

    Dynavax is a commercial stage biopharmaceutical company developing and commercializing novel vaccines. The Company launched its first commercial product, HEPLISAV-B® [Hepatitis B Vaccine (Recombinant), Adjuvanted], in February 2018, following U.S. FDA approval for prevention of infection caused by all known subtypes of hepatitis B virus in adults age 18 years and older. Dynavax is also advancing CpG 1018 as an advanced vaccine adjuvant through research collaborations and partnerships. For more information, visit www.dynavax.com

    About CEPI

    CEPI is an innovative partnership between public, private, philanthropic, and civil organizations, launched at Davos in 2017, to develop vaccines to stop future epidemics. CEPI has moved with great urgency and in coordination with WHO in response to the emergence of COVID-19. CEPI has initiated nine partnerships to develop vaccines against the novel coronavirus. The programs will leverage rapid response platforms already supported by CEPI as well as new partnerships.

    Before the emergence of COVID-19 CEPI's priority diseases included Ebola virus, Lassa virus, Middle East Respiratory Syndrome coronavirus, Nipah virus, Rift Valley Fever and Chikungunya virus. CEPI also invested in platform technologies that can be used for rapid vaccine and immunoprophylactic development against unknown pathogens (Disease X).

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