DVAX Dynavax Technologies Corporation

4.32
-0.08  -2%
Previous Close 4.4
Open 4.4
52 Week Low 1.8
52 Week High 12.44
Market Cap $473,090,121
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Av. Daily Volume 4,798,223
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Upcoming Catalysts

Drug Stage Catalyst Date
CpG 1018 and Medicago candidate
COVID-19 vaccine
Phase 1
Phase 1
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SCB-2019 + adjuvant system (Clover)
COVID-19 vaccine
Phase 1
Phase 1
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HEPLISAV-B
End Stage Renal Disease on Dialysis undergoing hemodialysis
Phase 1
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Drug Pipeline

Drug Stage Notes
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

    • Preclinical data show Clover's protein-based adjuvanted COVID-19 vaccine candidate, S-Trimer, induces a strong neutralizing immune response in animalsand protects nonhuman primates from SARS-CoV-2 challenge
    • Strong immune response and protection observed with adjuvant systems from GSK and Dynavax led to inclusion of both adjuvants separately into Clover's ongoing Phase 1 clinical trial of S-Trimer
    • Clover's ongoing Phase 1 trial of S-Trimer COVID-19 vaccine candidate completed enrollment of 150 adult and elderly participants in dose escalation, with 200 additional subjects planned for enrollment in dose expansion
    • A global Phase 2/3 efficacy clinical study of the COVID-19 S-Trimer program is planned before the end of 2020

    Clover Biopharmaceuticals

    • Preclinical data show Clover's protein-based adjuvanted COVID-19 vaccine candidate, S-Trimer, induces a strong neutralizing immune response in animalsand protects nonhuman primates from SARS-CoV-2 challenge
    • Strong immune response and protection observed with adjuvant systems from GSK and Dynavax led to inclusion of both adjuvants separately into Clover's ongoing Phase 1 clinical trial of S-Trimer
    • Clover's ongoing Phase 1 trial of S-Trimer COVID-19 vaccine candidate completed enrollment of 150 adult and elderly participants in dose escalation, with 200 additional subjects planned for enrollment in dose expansion
    • A global Phase 2/3 efficacy clinical study of the COVID-19 S-Trimer program is planned before the end of 2020

    Clover Biopharmaceuticals, a global clinical-stage biotechnology company focused on discovering and developing transformative biologic therapies and vaccines, today announced positive preclinical data demonstrating that its protein-based COVID-19 S-Trimer vaccine candidate in combination with adjuvants from either GSK (London Stock Exchange: GSK) or Dynavax (NASDAQ:DVAX) induces a strong immune response and protection against SARS-CoV-2 in animal models. The manuscript describing the results titled "S-Trimer, a COVID-19 subunit vaccine candidate, induces protective immunity in nonhuman primates" has been submitted for peer review and can be accessed on an online preprint server at bioRxiv.

    Joshua Liang, Chief Executive Officer of Clover Biopharmaceuticals, said, "We are excited to share these important preclinical results showing that our S-Trimer COVID-19 vaccine candidate induces immune protection against SARS-CoV-2, and we are also pleased with the progress and preliminary data of our Phase 1 clinical trial evaluating S-Trimer. More than ever, we remain committed to developing a safe, effective and accessible COVID-19 vaccine at a scale that could contribute to the control of the pandemic globally."

    Thomas Breuer, Chief Medical Officer of GSK Vaccines, commented, "We are pleased with the preclinical results that, together with the preliminary insights from the Phase 1 clinical data, underline expectations that the GSK pandemic adjuvant system combined with Clover's antigen leads to a substantial strengthening of the immune response with the promise of higher efficacy and dose sparing capabilities. Adjuvants are powerful tools in the global fight against the COVID-19 pandemic, and we are looking forward to seeing the progress of the vaccine candidate using GSK's pandemic adjuvant technology."

    Rob Janssen, Chief Medical Officer of Dynavax, commented, "We are pleased with the strong preclinical results observed when Dynavax's advanced adjuvant CpG 1018 plus alum was combined with Clover's S-Trimer antigen. We are especially encouraged by the absence of measurable viral load in lung tissue as well as other clinical measures in non-human primates challenged with SARS-CoV-2, and by the Th1-polarized T cell response in rodents. These data demonstrate CpG 1018's potential to significantly increase efficacy by rapidly controlling infection. We are proud to be collaborating with Clover on the development of this vaccine for COVID-19, and are committed to supporting Clover in making the vaccine available globally."

    Dr. Peng Liang, Founder and Chairman of Clover and inventor of Trimer-Tag© technology, added, "Together with an accompanying manuscript entitled ‘Cryo-EM structure of S-Trimer, a subunit vaccine candidate for COVID-19' which discloses that our S-Trimer resembles the native SARS-CoV-2 spike antigen in atomic resolution, our complete preclinical studies validate Trimer-Tag© as a potential platform technology for subunit vaccine development against current and future enveloped RNA viruses."

    Clover's COVID-19 S-Trimer vaccine was developed by combining the trimeric SARS-CoV-2 spike (S)-protein with the company's proprietary Trimer-Tag© technology. In preclinical studies, adjuvanted S-Trimer induced strong humoral and Th1-biased cell-mediated immune responses in mice, rats and monkeys, with levels of neutralizing antibodies at or higher than levels observed in human convalescent sera. Rhesus macaques that received the vaccine and were subsequently challenged with SARS-CoV-2 virus were protected against infection, as demonstrated by clinical observations (protection from body weight loss and increases in body temperature) and significant reduction in viral loads in lung tissues and swabs, with no signs of disease enhancement. Strong immune responses and protection were observed when the S-Trimer was administered with either GSK's pandemic adjuvant system or Dynavax's CpG 1018 adjuvant plus alum. These positive preclinical data supported the decision to progress adjuvanted vaccine candidates using both adjuvants into Clover's ongoing Phase 1 clinical study of S-Trimer in healthy adult and elderly participants.

    In June 2020, Clover announced the start of a Phase 1 clinical trial. The trial is a randomized, observer-blind, placebo-controlled study to assess the safety, reactogenicity and immunogenicity of the adjuvanted COVID-19 S-Trimer vaccine at multiple dose levels. The study has completed enrollment of 150 adult and elderly participants. Preliminary results show that the vaccine is likely to be safe and well-tolerated, with high levels of neutralizing antibodies observed. Based on these preliminary results, an additional 200 participants will be enrolled in a Phase 1 dose-expansion study at the selected S-Trimer dose-level and adjuvanted with either GSK's pandemic adjuvant or Dynavax's advanced adjuvant CpG 1018 plus alum. Clover intends to initiate a global Phase 2/3 vaccine efficacy study before the end of 2020. Detailed Phase 1 data will be made available in a peer-reviewed publication in the near future. The clinical trials and Clover's COVID-19 vaccine program are being supported by funding and collaboration with the Coalition for Epidemic Preparedness Innovations (CEPI).

    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 $200 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 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.

    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.

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  1. EMERYVILLE, Calif., Sept. 24, 2020 /PRNewswire/ -- Dynavax Technologies Corporation (NASDAQ:DVAX), a biopharmaceutical company focused on developing and commercializing novel vaccines, today announced the appointment of Peter R. Paradiso, Ph.D. to its Board of Directors.  Separately, the Company also announced that Michael Ostrach, Senior Vice President, Chief Financial Officer (CFO) and Chief Business Officer (CBO), has communicated his planned retirement in 2021.

    "We are excited to welcome Peter to our Board of Directors. Peter brings over three decades of vaccine strategic planning and development expertise.  I look forward to his strategic guidance as Dynavax continues to build a leading vaccine company on the foundation of HEPLISAV-B…

    EMERYVILLE, Calif., Sept. 24, 2020 /PRNewswire/ -- Dynavax Technologies Corporation (NASDAQ:DVAX), a biopharmaceutical company focused on developing and commercializing novel vaccines, today announced the appointment of Peter R. Paradiso, Ph.D. to its Board of Directors.  Separately, the Company also announced that Michael Ostrach, Senior Vice President, Chief Financial Officer (CFO) and Chief Business Officer (CBO), has communicated his planned retirement in 2021.

    "We are excited to welcome Peter to our Board of Directors. Peter brings over three decades of vaccine strategic planning and development expertise.  I look forward to his strategic guidance as Dynavax continues to build a leading vaccine company on the foundation of HEPLISAV-B, our FDA-approved adult hepatitis B vaccine, and CpG 1018, our advanced vaccine adjuvant," commented Ryan Spencer, Chief Executive Officer of Dynavax. "At the same time, Michael's skills, breadth of experience, and unwavering commitment to Dynavax have been critical to the success of our company. He has been an outstanding leader, an esteemed colleague, and a tremendous mentor. While his contributions will be missed, we wish him well for retirement and his next adventures."

    "I am thrilled to join Dynavax's Board of Directors at this exciting time in the company's growth," commented Peter Paradiso, Ph.D. "I am impressed with the organization's commercial execution for HEPLISAV-B and the tremendous progress on making their advanced adjuvant, CpG 1018, available to collaboration partners in the pursuit of protecting the world against infectious diseases."

    "I am grateful for the opportunity to serve Dynavax and work alongside the dedicated individuals in my groups and across our organization over the past 14 years to advance our company's mission to deliver novel vaccines.  It is particularly gratifying that those efforts resulted in the approval and commercialization of our two-dose adult hepatitis b vaccine, HEPLISAV-B, as well as clinical trials of multiple COVID-19 vaccine candidates testing our CpG 1018 adjuvant." said Mr. Ostrach.

    Dr. Paradiso has worked in vaccine development for over 30 years. He is currently the sole proprietor of Paradiso Biologics Consulting, LLC. and serves as a member of the Coalition for Epidemic Preparedness Innovations (CEPI) R&D and Manufacturing Investment Committee (RDMIC), which has been established to make investment decisions for vaccine R&D and manufacturing under the COVAX pillar of the ACT-Accelerator.  In addition, he is Chairman of a Procurement Reference Group (PRG) to advise The United Nations Children's Fund (UNICEF) and The GAVI Alliance – formerly the Global Alliance for Vaccines and Immunisation (GAVI) on the procurement of rotavirus vaccines. Dr. Paradiso retired in 2012 where he served as Vice President, New Business and Scientific Affairs for Pfizer Vaccines, a Division of Pfizer, Inc. In this position, Dr. Paradiso was responsible for global scientific affairs and strategic planning within the vaccine research and development group and for commercial oversight of products in development.  Dr. Paradiso received a Doctor of Philosophy (PhD) degree in biochemistry from the University of Vermont College of Medicine and a BS in Chemistry from St. Lawrence University.

    As part of the planned transition next year, Dynavax has retained Russell Reynolds Associates to assist the Company in recruiting its next CFO. Mr. Ostrach will continue in his role while the Company identifies a successor.  If a new CFO is appointed before March 31, 2021, Mr. Ostrach has agreed to remain in an advisory capacity through the completion of the Company's reporting of 2020 financial results and to remain available as an advisor to the Company thereafter. The Company does not intend to fill the CBO position at the time of Mr. Ostrach's retirement.

    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 further developing CpG 1018 as an advanced 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, Senior Manager, Investor Relations

     

    510-665-7264

    Derek Cole, President

    Investor Relations Advisory Solutions

    Cision View original content:http://www.prnewswire.com/news-releases/dynavax-announces-appointment-of-new-board-member-and-planned-retirement-of-chief-financial-officer-301137802.html

    SOURCE Dynavax Technologies

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  2. 

    • Dynavax will provide CpG 1018 to produce up to 190 million doses over a five year period to support Valneva's contract with the U.K. government
    • Inactivated, adjuvanted SARS-COV-2 vaccine candidate scheduled to enter first clinical studies in December 2020
      • Combines Valneva's proven approach with Dynavax's advanced CpG 1018 adjuvant

    Saint-Herblain (France) and Emeryville (U.S.), September 14, 2020Valneva SE ("Valneva"), a specialty vaccine company focused on prevention of diseases with major unmet needs, and Dynavax Technologies Corporation (NASDAQ:DVAX), a biopharmaceutical company focused on developing and commercializing novel vaccines, today announced a commercial partnership for the supply of Dynavax's CpG 1018 adjuvant for use in…

    

    • Dynavax will provide CpG 1018 to produce up to 190 million doses over a five year period to support Valneva's contract with the U.K. government
    • Inactivated, adjuvanted SARS-COV-2 vaccine candidate scheduled to enter first clinical studies in December 2020
      • Combines Valneva's proven approach with Dynavax's advanced CpG 1018 adjuvant

    Saint-Herblain (France) and Emeryville (U.S.), September 14, 2020Valneva SE ("Valneva"), a specialty vaccine company focused on prevention of diseases with major unmet needs, and Dynavax Technologies Corporation (NASDAQ:DVAX), a biopharmaceutical company focused on developing and commercializing novel vaccines, today announced a commercial partnership for the supply of Dynavax's CpG 1018 adjuvant for use in Valneva's SARS-CoV-2 vaccine candidate, VLA2001.  Valneva separately announced today an agreement with the UK government to provide up to 190 million doses of VLA20011 over a five year period. Dynavax will supply CpG 1018 to produce up to 100 million doses of vaccine in 2021. Valneva has the option to purchase up to an additional 90 million doses through 2025.

    Thomas Lingelbach, Chief Executive Officer of Valneva, commented, "We are pleased to partner with Dynavax on the further development and future commercialization of our COVID-19 vaccine. We believe that CpG 1018 will add significant value to the target product profile of our vaccine including its intended use in at risk populations. This agreement marks another step in our approach to find a safe and effective solution to address the virus that is continuing to have an impact on us all."

    Ryan Spencer, Chief Executive Officer of Dynavax, commented, "Dynavax is proud to be working with Valneva to support development and commercialization of an adjuvanted vaccine candidate to prevent COVID-19. We are pleased to extend our current partnership to include commercial supply of CpG 1018, our advanced adjuvant. We believe CpG 1018 may play a critical role in the development of a safe and effective vaccine, including potentially enhancing the immune response for those who are traditionally less responsive to vaccination and are at greatest risk for severe disease from COVID-19."

    Valneva expects VLA2001 to enter clinical studies by the end of 2020 and to potentially reach regulatory approval in the second half of 2021.

    This commercial supply partnership follows Valneva and Dynavax's initial collaboration to advance COVID-19 vaccine development, announced in April 20202.

    About VLA2001

    VLA2001 is a Vero-cell based, highly purified inactivated vaccine candidate against the SARS-CoV-2 virus, leveraging the manufacturing technology for Valneva's Japanese encephalitis vaccine. The Company has designed a process that largely uses this platform in regards to upstream- and downstream process steps as plug-and-play with moderate adjustments. The process includes inactivation with BPL to preserve the native structure of the S protein. The combination with CpG 1018 is expected to induce a strong immune response and has the potential to generate high titers of neutralizing antibodies as well as a polarized Th1 response. VLA2001 is expected to conform with standard cold chain requirements (2 degrees to 8 degrees centigrade).

    About Valneva SE

    Valneva is a specialty vaccine company focused on prevention against diseases with major unmet needs. Valneva's portfolio includes two commercial vaccines for travelers: IXIARO®/JESPECT® indicated for the prevention of Japanese encephalitis and DUKORAL® indicated for the prevention of cholera and, in some countries, prevention of diarrhea caused by ETEC. The Company has various vaccines in development including unique vaccines against Lyme disease, chikungunya and SARS-CoV-2. Valneva has operations in Austria, Sweden, the United Kingdom, France, Canada and the US with over 500 employees. For more information, visit the Company website at www.valneva.com and follow Valneva on LinkedIn.

    About Vaccine Adjuvants

    An adjuvant is a pharmacological or immunological agent that modifies the effect of other agents. Adjuvants are added to a vaccine to boost the immune response to produce more antibodies and longer-lasting immunity, thus minimizing the dose of antigen needed. Adjuvants may also be used to enhance the efficacy of a vaccine by helping to modify the immune response by particular types of immune system cells.

    About CpG 1018 Adjuvant

    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 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 further developing CpG 1018 as an advanced 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 development of a COVID-19 vaccine containing CpG 1018 and the commercial sale of CpG 1018 to be used in the vaccine. 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, the results of clinical trials, whether CpG 1018 will provide an enhanced immune response,  whether and when the vaccine containing CpG 1018 will be approved for use, whether and when purchases of CpG 1018 will occur, and the ability to manufacture sufficient supply to meet the purchasing needs,  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.

    Valneva Forward-Looking Statements

    This press release contains certain forward-looking statements relating to the business of Valneva, including with respect to the progress, timing and completion of research, development and clinical trials for product candidates, the ability to manufacture, market, commercialize and achieve market acceptance for product candidates, the ability to protect intellectual property and operate the business without infringing on the intellectual property rights of others, estimates for future performance and estimates regarding anticipated operating losses, future revenues, capital requirements and needs for additional financing. In addition, even if the actual results or development of Valneva are consistent with the forward-looking statements contained in this press release, those results or developments of Valneva may not be indicative of their in the future. In some cases, you can identify forward-looking statements by words such as "could," "should," "may," "expects," "anticipates," "believes," "intends," "estimates," "aims," "targets," or similar words. These forward-looking statements are based largely on the current expectations of Valneva as of the date of this press release and are subject to a number of known and unknown risks and uncertainties and other factors that may cause actual results, performance or achievements to be materially different from any future results, performance or achievement expressed or implied by these forward-looking statements. In particular, the expectations of Valneva could be affected by, among other things, uncertainties involved in the development and manufacture of vaccines, unexpected clinical trial results, unexpected regulatory actions or delays, competition in general, currency fluctuations, the impact of the global and European credit crisis, and the ability to obtain or maintain patent or other proprietary intellectual property protection. In light of these risks and uncertainties, there can be no assurance that the forward-looking statements made during this presentation will in fact be realized. Valneva is providing the information in these materials as of this press release, and disclaim any intention or obligation to publicly update or revise any forward-looking statements, whether as a result of new information, future events, or otherwise.

    Valneva Investor and Media Contacts

    David Lawrence

    Chief Financial Officer

    +447908627213



     



    Laetitia Bachelot-Fontaine

    Director Investor Relations & Corporate Communications

    M +33 (0)6 4516 7099

            
     



     

    Dynavax Contacts

    Nicole Arndt, Senior Manager, Investor Relations



    510-665-7264

    Derek Cole, President

    Investor Relations Advisory Solutions


    1 Valneva Confirms Participation in UK Government COVID-19 Vaccine Response Program

    2 Valneva and Dynavax Announce Collaboration to Advance Vaccine Development for COVID-19





     

     

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  3. SAINT-HERBLAIN, France and EMERYVILLE, Calif., Sept. 14, 2020 /PRNewswire/ -- Valneva SE ("Valneva"), a specialty vaccine company focused on prevention of diseases with major unmet needs, and Dynavax Technologies Corporation (NASDAQ:DVAX), a biopharmaceutical company focused on developing and commercializing novel vaccines, today announced a commercial partnership for the supply of Dynavax's CpG 1018 adjuvant for use in Valneva's SARS-CoV-2 vaccine candidate, VLA2001.  Valneva separately announced today an agreement with the UK government to provide up to 190 million doses of VLA20011 over a five year period. Dynavax will supply CpG 1018 to produce up to 100 million doses of vaccine in 2021. Valneva has the option to purchase up to an additional…

    SAINT-HERBLAIN, France and EMERYVILLE, Calif., Sept. 14, 2020 /PRNewswire/ -- Valneva SE ("Valneva"), a specialty vaccine company focused on prevention of diseases with major unmet needs, and Dynavax Technologies Corporation (NASDAQ:DVAX), a biopharmaceutical company focused on developing and commercializing novel vaccines, today announced a commercial partnership for the supply of Dynavax's CpG 1018 adjuvant for use in Valneva's SARS-CoV-2 vaccine candidate, VLA2001.  Valneva separately announced today an agreement with the UK government to provide up to 190 million doses of VLA20011 over a five year period. Dynavax will supply CpG 1018 to produce up to 100 million doses of vaccine in 2021. Valneva has the option to purchase up to an additional 90 million doses through 2025.

    Thomas Lingelbach, Chief Executive Officer of Valneva, commented, "We are pleased to partner with Dynavax on the further development and future commercialization of our COVID-19 vaccine. We believe that CpG 1018 will add significant value to the target product profile of our vaccine including its intended use in at risk populations. This agreement marks another step in our approach to find a safe and effective solution to address the virus that is continuing to have an impact on us all."

    Ryan Spencer, Chief Executive Officer of Dynavax, commented, "Dynavax is proud to be working with Valneva to support development and commercialization of an adjuvanted vaccine candidate to prevent COVID-19. We are pleased to extend our current partnership to include commercial supply of CpG 1018, our advanced adjuvant. We believe CpG 1018 may play a critical role in the development of a safe and effective vaccine, including potentially enhancing the immune response for those who are traditionally less responsive to vaccination and are at greatest risk for severe disease from COVID-19."

    Valneva expects VLA2001 to enter clinical studies by the end of 2020 and to potentially reach regulatory approval in the second half of 2021.

    This commercial supply partnership follows Valneva and Dynavax's initial collaboration to advance COVID-19 vaccine development, announced in April 20202.

    About VLA2001

    VLA2001 is a Vero-cell based, highly purified inactivated vaccine candidate against the SARS-CoV-2 virus, leveraging the manufacturing technology for Valneva's Japanese encephalitis vaccine. The Company has designed a process that largely uses this platform in regards to upstream- and downstream process steps as plug-and-play with moderate adjustments. The process includes inactivation with BPL to preserve the native structure of the S protein. The combination with CpG 1018 is expected to induce a strong immune response and has the potential to generate high titers of neutralizing antibodies as well as a polarized Th1 response. VLA2001 is expected to conform with standard cold chain requirements (2 degrees to 8 degrees centigrade).

    About Valneva SE

    Valneva is a specialty vaccine company focused on prevention against diseases with major unmet needs. Valneva's portfolio includes two commercial vaccines for travelers: IXIARO®/JESPECT® indicated for the prevention of Japanese encephalitis and DUKORAL® indicated for the prevention of cholera and, in some countries, prevention of diarrhea caused by ETEC. The Company has various vaccines in development including unique vaccines against Lyme disease, chikungunya and SARS-CoV-2. Valneva has operations in Austria, Sweden, the United Kingdom, France, Canada and the US with over 500 employees. For more information, visit the Company website at www.valneva.com and follow Valneva on LinkedIn.

    About Vaccine Adjuvants

    An adjuvant is a pharmacological or immunological agent that modifies the effect of other agents. Adjuvants are added to a vaccine to boost the immune response to produce more antibodies and longer-lasting immunity, thus minimizing the dose of antigen needed. Adjuvants may also be used to enhance the efficacy of a vaccine by helping to modify the immune response by particular types of immune system cells.

    About CpG 1018 Adjuvant

    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 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 further developing CpG 1018 as an advanced 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 development of a COVID-19 vaccine containing CpG 1018 and the commercial sale of CpG 1018 to be used in the vaccine.  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, the results of clinical trials, whether CpG 1018 will provide an enhanced immune response,  whether and when the vaccine containing CpG 1018 will be approved for use, whether and when purchases of CpG 1018 will occur, and the ability to manufacture sufficient supply to meet the purchasing needs,  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.

    Valneva Forward-Looking Statements

    This press release contains certain forward-looking statements relating to the business of Valneva, including with respect to the progress, timing and completion of research, development and clinical trials for product candidates, the ability to manufacture, market, commercialize and achieve market acceptance for product candidates, the ability to protect intellectual property and operate the business without infringing on the intellectual property rights of others, estimates for future performance and estimates regarding anticipated operating losses, future revenues, capital requirements and needs for additional financing. In addition, even if the actual results or development of Valneva are consistent with the forward-looking statements contained in this press release, those results or developments of Valneva may not be indicative of their in the future. In some cases, you can identify forward-looking statements by words such as "could," "should," "may," "expects," "anticipates," "believes," "intends," "estimates," "aims," "targets," or similar words. These forward-looking statements are based largely on the current expectations of Valneva as of the date of this press release and are subject to a number of known and unknown risks and uncertainties and other factors that may cause actual results, performance or achievements to be materially different from any future results, performance or achievement expressed or implied by these forward-looking statements. In particular, the expectations of Valneva could be affected by, among other things, uncertainties involved in the development and manufacture of vaccines, unexpected clinical trial results, unexpected regulatory actions or delays, competition in general, currency fluctuations, the impact of the global and European credit crisis, and the ability to obtain or maintain patent or other proprietary intellectual property protection. In light of these risks and uncertainties, there can be no assurance that the forward-looking statements made during this presentation will in fact be realized. Valneva is providing the information in these materials as of this press release, and disclaim any intention or obligation to publicly update or revise any forward-looking statements, whether as a result of new information, future events, or otherwise.

    Valneva Investor and Media Contacts

    Laetitia Bachelot-Fontaine

    Director of Investor Relations & Corporate Communications

    M +33 (0)6 4516 7099

     

     

    Teresa Pinzolits

    Corporate Communications Specialist

    T +43 (0)1 20620 1116

    Dynavax Contacts

    Nicole Arndt, Senior Manager, Investor Relations

     

    510-665-7264

    Derek Cole, President

    Investor Relations Advisory Solutions

    1 Valneva Confirms Participation in UK Government COVID-19 Vaccine Response Program 

    2 Valneva and Dynavax Announce Collaboration to Advance Vaccine Development for COVID-19

    Cision View original content to download multimedia:http://www.prnewswire.com/news-releases/valneva-and-dynavax-announce-commercial-supply-agreement-for-inactivated-adjuvanted-covid-19-vaccine-301129818.html

    SOURCE Dynavax Technologies

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  4. EMERYVILLE, Calif., Aug. 31, 2020 (GLOBE NEWSWIRE) -- Dynavax Technologies Corporation (NASDAQ:DVAX), a biopharmaceutical company focused on developing and commercializing novel vaccines, today announced that Ryan Spencer, Chief Executive Officer, will participate in a virtual fireside chat at the H.C. Wainwright Virtual 22nd Annual Global Investment Conference on Monday, September 14, at 10:00 a.m. ET.

    The presentation will be webcast 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 launched its…

    EMERYVILLE, Calif., Aug. 31, 2020 (GLOBE NEWSWIRE) -- Dynavax Technologies Corporation (NASDAQ:DVAX), a biopharmaceutical company focused on developing and commercializing novel vaccines, today announced that Ryan Spencer, Chief Executive Officer, will participate in a virtual fireside chat at the H.C. Wainwright Virtual 22nd Annual Global Investment Conference on Monday, September 14, at 10:00 a.m. ET.

    The presentation will be webcast 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 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 further developing CpG 1018 as an advanced 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

    Primary Logo

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