DVAX Dynavax Technologies Corporation

10.07
+0.1  (+1%)
Previous Close 9.97
Open 9.9
52 Week Low 2.89
52 Week High 12.44
Market Cap $1,140,488,937
Shares 113,256,101
Float 85,510,338
Enterprise Value $1,181,974,326
Volume 1,278,506
Av. Daily Volume 6,533,018
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Upcoming Catalysts

Drug Stage Catalyst Date
Biological E. vaccine with CpG 1018
COVID-19 vaccine
Phase 1/2
Phase 1/2
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S-Trimer COVID-19 Vaccine + CpG 1018 adjuvant plus alum (SPECTRA)
COVID-19 vaccine
Phase 2/3
Phase 2/3
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CpG 1018 adjuvanted Tdap vaccine
Tetanus/Diphtheria/Pertussis Booster Vaccine
Phase 1
Phase 1
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Drug Pipeline

Drug Stage Notes
VLA2001-201 + alum and CpG 1018
COVID-19 vaccine
Phase 1/2
Phase 1/2
Phase 3 trial to commence by end of April 2021.
Medigen with CpG 1018
COVID-19 vaccine
Phase 1
Phase 1
Phase 2 initiated January 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., April 6, 2021 /PRNewswire/ -- Dynavax Technologies Corporation (NASDAQ:DVAX), a biopharmaceutical company focused on developing and commercializing novel vaccines, today announced that Valneva SE reported positive initial results for Part A of the Phase 1/2 clinical trial of Valneva's inactivated COVID-19 vaccine candidate, VLA2001, using Dynavax's  CpG 1018™ adjuvant in 153 healthy adults aged 18 to 55 years. Based on these results, Valneva plans to commence a pivotal Phase 3 clinical trial by the end of April 2021, subject to regulatory approval.

    In their press release issued April 6th, 2021 (available here), Valneva reported that VLA2001 was generally safe and well tolerated across all dose groups tested and was highly immunogenic with a seroconversion rate for S-protein binding IgG antibodies of 100% in the high dose group. The IgG antibody response was highly correlated with neutralization titers in a micro-neutralization assay.  The geometric mean titer of neutralizing antibodies measured two weeks after completion of the two-dose schedule in this group was at or above levels for a panel of convalescent sera.  

    Ryan Spencer, Chief Executive Officer Dynavax, said, "We are excited to see the positive results Valneva has generated with their inactivated vaccine using Dynavax's CpG 1018 adjuvant. We believe the effect delivered by our CpG 1018 adjuvant combined with Valneva's existing manufacturing process for whole virus inactivated vaccines will result in an important option in the global fight against COVID-19. This platform has potential to allow rapid modifications to the vaccine as needed to address variants using Valneva's existing manufacturing process."

    Valneva plans to initiate a pivotal, comparative immunogenicity Phase 3 clinical trial with the high dose formulation by the end of April 2021. Other trials, including booster trials, involving antigen sparing doses will also be evaluated.

    About VLA2001

    VLA2001 is intended for active immunization of at-risk populations to prevent carriage and symptomatic infection with COVID-19 during the ongoing pandemic and potentially later for routine vaccination including addressing new variants. VLA2001 is produced on Valneva's established Vero-cell platform, leveraging the manufacturing technology for Valneva's licensed Japanese encephalitis vaccine, IXIARO®. VLA2001 consists of inactivated whole virus particles of SARS-CoV-2 with high S-protein density, in combination with two adjuvants, alum and CpG 1018. The process includes inactivation with BPL to preserve the native structure of the S-protein. Valneva expects VLA2001 to conform with standard cold chain requirements (2 degrees to 8 degrees Celsius).

    About CpG 1018 Adjuvant

    CpG 1018 adjuvant is used in HEPLISAV-B® [Hepatitis B Vaccine (Recombinant), Adjuvanted], an adult hepatitis B vaccine approved by the U.S. Food and Drug Administration (FDA) and the European Medicines Agency. 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.

    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. and Europe for prevention of infection caused by all known subtypes of hepatitis B virus in adults age 18 years and older. Dynavax is also advancing its CpG 1018 adjuvant 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 development (including the timing for a Phase 3 clinical trial and regulatory submission) and importance of a COVID-19 vaccine containing CpG 1018 adjuvant, the potential of the platform to address variants, and the evaluation of other trials.  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, dose selection, the results of clinical trials, whether and when the vaccine containing CpG 1018 adjuvant will be approved for use, whether and when purchases of CpG 1018 adjuvant 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, 2020 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.

    Dynavax 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/positive-phase-12-results-for-valnevas-inactivated-covid-19-vaccine-candidate-using-dynavaxs-cpg-1018-adjuvant-301262647.html

    SOURCE Dynavax Technologies

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  2.  

    • VLA2001 was well tolerated with no safety concerns identified
       
    • In the high dose group :
       
      • IgG seroconversion rate of 100%
         
      • Neutralizing antibody titres at or above levels generally seen in convalescent sera.

    Saint-Herblain (France), April 6, 2021Valneva SE, a specialty vaccine company focused on the development and commercialization of prophylactic vaccines for infectious diseases with significant unmet medical need, today announced positive data for Part A of the Phase 1/2 clinical trial of its inactivated, adjuvanted COVID-19 vaccine candidate, VLA2001. Based on this data, the Company plans to commence a Phase 3 clinical trial by the end of April 2021, subject to regulatory approval.

    In study VLA2001-201, three dose levels of VLA2001…



     

    • VLA2001 was well tolerated with no safety concerns identified

       
    • In the high dose group :

       
      • IgG seroconversion rate of 100%

         
      • Neutralizing antibody titres at or above levels generally seen in convalescent sera.

    Saint-Herblain (France), April 6, 2021Valneva SE, a specialty vaccine company focused on the development and commercialization of prophylactic vaccines for infectious diseases with significant unmet medical need, today announced positive data for Part A of the Phase 1/2 clinical trial of its inactivated, adjuvanted COVID-19 vaccine candidate, VLA2001. Based on this data, the Company plans to commence a Phase 3 clinical trial by the end of April 2021, subject to regulatory approval.

    In study VLA2001-201, three dose levels of VLA2001 (low, medium, high), based on a schedule of two doses with vaccinations three weeks apart, were evaluated in 153 healthy adults aged 18 to 55 years.

    VLA2001 was generally safe and well tolerated across all dose groups tested, with no safety concerns identified by an independent Data Safety Monitoring Board. There were no statistically significant differences between dose groups and no differences between first and second vaccinations in terms of reactogenicity. The majority of Adverse Events (AEs) were mild or moderate and only two subjects reported severe solicited AEs (headache and fatigue). All solicited AEs were transient. Only 17.6% of unsolicited AEs up to day 36 were considered related to the vaccine and no severe unsolicited AEs were reported. No serious related AEs were reported.

    VLA2001 was highly immunogenic with more than 90% of all study participants developing significant levels of antibodies to the SARS-CoV-2 virus spike protein across all dose groups tested. Seroconversion Rates (SCR) for S-protein binding IgG antibodies were 89.8% in the medium dose and 100% in the high dose group. Two weeks after completion of the two dose schedule, Geometric Mean Fold Rise (GMFR) from baseline were 26 in the medium dose and 86 in the high dose group.

    Of note, the IgG antibody response was highly correlated with neutralization titres in a micro-neutralization assay (MNA50) (r=0.79, p<0.001).

    VLA2001 induced a dose dependent response with statistically significant higher Geometric Mean Titres (GMTs) for both IgG and neutralizing antibodies in the high dose group compared to the low and medium dose groups. In the high dose group, the GMT of neutralizing antibody titres measured two weeks after completion of the two-dose schedule was at or above levels for a panel of convalescent sera (GMT 530.4 (95% CI: 421.49, 667.52)).

    With a GMT ratio of vaccine vs. convalescent sera ≥ 1, vaccine efficacy has been reported above 80% for other vaccines1.

    VLA2001 induced broad T-cell responses across participants with antigen-specific IFN-gamma producing T-cells against the S-protein, M and N protein detected in 75.6 %, 35.6% and 48.9% of study participants, respectively.

    Thomas Lingelbach, Chief Executive Officer of Valneva, said: "We are extremely pleased with these results which take us a step closer to providing an inactivated vaccine to help the global fight against COVID-19. The world needs multiple vaccines as well as booster options. Given the potential advantages often associated with inactivated whole virus vaccines, we believe that VLA2001 has an important role to play. This includes potential modifications to the vaccine to address variants, using our existing manufacturing process. I want to thank everyone involved in the ongoing work. We could not have achieved this milestone without them."

    Health and Social Care Secretary, Matt Hancock said: "The U.K. government has funded these clinical trials and it is fantastic to see Valneva's vaccine produces a strong immune response. This vaccine will be made onshore in Livingston in Scotland, giving another boost to British life science, and if approved will play an important role in protecting our communities. I look forward to seeing the results of the upcoming phase 3 trial."

    Vaccines Minister Nadhim Zahawi said:  "These results are very promising and provide renewed hope that a vaccine using a whole inactivated virus might provide strong protection against variants. If the results from the phase 3 clinical trials are positive and the vaccine meets the robust standards of safety, quality and effectiveness of our medicines regulator, the MHRA, this will be another powerful weapon in our arsenal to beat this pandemic. The government has funded the clinical trials for this promising vaccine and, if approved, it will be manufactured in Scotland, boosting the UK's ability to become more self-sufficient in the future."

    Clive Dix, Chair of the Vaccines Taskforce said: "These are great results from Valneva, particularly around the antibody and cellular responses generated and low numbers of adverse events, as these indicate good levels of immune responses among the participants to date. The findings of 100% levels of immunogenicity against the viral spike protein in the high-dose group is also encouraging. Inactivated virus vaccines are proven technologies that are often able to induce wide-ranging immune responses, and these promising data indicate that VLA2001 may continue this trend. We are hopeful of seeing good results from the upcoming Phase 3 trials, and look forward to continuing working closely with Valneva on their vaccine."

    Based on the data assessed, the Company has decided to advance the high dose into the Phase 3 clinical trial. Other trials, including booster trials, involving antigen sparing doses will also be evaluated.

    The Company continues to work closely with the UK Government to review plans including potential variant vaccine development and supply as well as meeting the UK's booster campaign requirements acknowledging the ongoing vaccine roll out in the UK. As a result, Valneva now believes that the timeline for delivery of 60 million doses of vaccine to the UK Government will extend into the first quarter of 2022. Based on the Phase 1/2 data, the Company is also investigating antigen sparing options for booster strategies. Overall capacity and delivery schedule will be dependent on the UK's vaccine requirements and production related factors.

    Valneva plans to initiate a pivotal, comparative immunogenicity Phase 3 clinical trial by the end of April 2021 with the aim of making a regulatory licensure submission to the Medicines and Healthcare products Regulatory Agency (MHRA) in the United Kingdom in the autumn 2021. Discussions with other regulatory bodies are ongoing.

    In parallel, Valneva has initiated the development of new variant based viral seed banks.

    About the Novel Coronavirus SARS-CoV-2 and COVID-19 Disease

    SARS-CoV-2 is a new coronavirus identified in late 2019 and belongs to a family of enveloped RNA viruses that include MERS and SARS, both of which caused serious human infections of the respiratory system. The virus, which causes a disease named COVID-19, has never before been found in humans. Since this outbreak was first reported, the virus has caused millions of deaths globally2. It has been declared a pandemic by the World Health Organization (WHO).

    About VLA2001-201

    VLA2001-201 is a randomized, dose-finding study to evaluate the safety, tolerability and immunogenicity of the inactivated, adjuvanted SARS-CoV-2 virus vaccine candidate VLA2001, against COVID-19 in healthy subjects. VLA2001-201 is the first-in-human Phase 1/2 study evaluating three dose levels of VLA2001 (low, medium, high) for safety, tolerability and immunogenicity in a two-dose schedule with intra muscular vaccinations three weeks apart. Overall, 153 healthy young adults aged 18 to 55 years have been recruited in the study. VLA2001-201 is being conducted in two parts: Part A (Day 1 to Day 36) and Part B (Day 37 to Day 208).

    This report is independent research paid for by the Department of Health and Social Care. The views expressed in this publication are those of the author(s) and not necessarily those of the Department of Health and Social Care.

    About VLA2001

    VLA2001 is currently the only whole virus, inactivated, adjuvanted vaccine candidate in clinical trials against COVID-19 in Europe. It is intended for active immunization of at-risk populations to prevent carriage and symptomatic infection with COVID-19 during the ongoing pandemic and potentially later for routine vaccination including addressing new variants. VLA2001 may also be suited for boosting, as repeat booster vaccinations have been shown to work well with whole virus inactivated vaccines. VLA2001 is produced on Valneva's established Vero-cell platform, leveraging the manufacturing technology for Valneva's licensed Japanese encephalitis vaccine, IXIARO®. VLA2001 consists of inactivated whole virus particles of SARS-CoV-2 with high S-protein density, in combination with two adjuvants, alum and CpG 1018. This adjuvant combination has consistently induced higher antibody levels in preclinical experiments than alum-only formulations and shown a shift of the immune response towards Th1. CpG 1018 adjuvant, supplied by Dynavax Technologies Corporation (NASDAQ:DVAX),  is a component of the US FDA- and EMA-approved HEPLISAV-B® vaccine. The manufacturing process for VLA2001, which has already been upscaled to final industrial scale, includes inactivation with BPL to preserve the native structure of the S-protein. VLA2001 is expected to conform with standard cold chain requirements (2 degrees to 8 degrees Celsius).

    About Valneva SE

    Valneva is a specialty vaccine company focused on the development and commercialization of prophylactic vaccines for infectious diseases with significant unmet medical need. We take a highly specialized and targeted approach to vaccine development, beginning with the identification of deadly and debilitating infectious diseases that lack a prophylactic vaccine solution and for which there are limited therapeutic treatment options. We then apply our deep understanding of vaccine science, including our expertise across multiple vaccine modalities, as well as our established vaccine development capabilities, to develop prophylactic vaccines to address these diseases. We have leveraged our expertise and capabilities both to successfully commercialize two vaccines and to rapidly advance a broad range of vaccine candidates into and through the clinic, including candidates against Lyme disease, the chikungunya virus and COVID-19.

     



    Valneva Investor and Media Contacts

    Laetitia Bachelot-Fontaine

    Director Investor Relations & Corporate Communications

    M +33 (0)6 4516 7099





     



               
     



     





     



      

    Dan Sharp

    Government & Public Affairs Manager

    T +44-(0)7436-244309



             
     



     

    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, results and completion of research, development and clinical trials for product candidates, timing and volume expectations with respect to the manufacture of our product candidates; the ability to 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 sustained 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. Success in preclinical studies or earlier clinical trials may not be indicative of results in future clinical trials. 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.


    1Earle et al. MedRxiv, March 2021, https://doi.org/10.1101/2021.03.17.20200246); Khoury et al. MedRxiv, March 2021, https://doi.org/10.1101/2021.03.09.21252641)

    2 https://www.worldometers.info/coronavirus/





     

     

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  3. EMERYVILLE, Calif., April 2, 2021 /PRNewswire/ -- Dynavax Technologies Corporation (NASDAQ:DVAX) today reported that it has granted nonstatutory stock options to purchase an aggregate of 142,000 shares of Dynavax common stock as inducements to six newly-hired employees in connection with commencement of employment with the Company.

    The stock options were granted on April 1, 2021 at an exercise price of $9.73 per share, which is equal to the closing price of Dynavax common stock on the date of grant. Each stock option granted has a 7-year term and vests over three years, with one-third of the shares underlying the option vesting on the one-year anniversary of the grant date, and the remaining shares vesting 1/36 per month in equal installments, subject to continued employment with Dynavax through the applicable vesting dates. 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.

    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. and Europe 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 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/dynavax-reports-inducement-grants-under-nasdaq-listing-rule-5635c4-301261396.html

    SOURCE Dynavax Technologies

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  4. CHENGDU, China and EMERYVILLE, Calif., March 24, 2021 /PRNewswire/ -- Clover Biopharmaceuticals (Clover), a global clinical-stage biotechnology company developing transformative biologics such as vaccines and therapeutics for the world's most debilitating diseases, and Dynavax Technologies Corporation ((Dynavax, NASDAQ:DVAX), a biopharmaceutical company focused on developing and commercializing novel vaccines, today announced the first participants have been dosed in Clover's SPECTRA trial (Study Evaluating Protective-Efficacy and Safety of Clover's Trimeric Recombinant Protein-based and Adjuvanted COVID-19 Vaccine), a global Phase 2/3 clinical trial evaluating the efficacy, safety and immunogenicity of  Clover's protein-based S-Trimer COVID-19…

    CHENGDU, China and EMERYVILLE, Calif., March 24, 2021 /PRNewswire/ -- Clover Biopharmaceuticals (Clover), a global clinical-stage biotechnology company developing transformative biologics such as vaccines and therapeutics for the world's most debilitating diseases, and Dynavax Technologies Corporation ((Dynavax, NASDAQ:DVAX), a biopharmaceutical company focused on developing and commercializing novel vaccines, today announced the first participants have been dosed in Clover's SPECTRA trial (Study Evaluating Protective-Efficacy and Safety of Clover's Trimeric Recombinant Protein-based and Adjuvanted COVID-19 Vaccine), a global Phase 2/3 clinical trial evaluating the efficacy, safety and immunogenicity of  Clover's protein-based S-Trimer COVID-19 vaccine candidate adjuvanted with Dynavax's CpG 1018 plus alum.

    The global Phase 2/3 trial is a double-blind, randomized, controlled study of the adjuvanted S-Trimer COVID-19 vaccine candidate in a two-dose regimen, given 21 days apart. The study is expected to enroll over 22,000 adult and elderly participants at multiple sites across Latin America, Asia, Europe and Africa. An independent external Data Safety Monitoring Board (DSMB) will provide safety oversight throughout the program by regular review of available efficacy and safety data. An interim analysis of the primary endpoint is expected in the middle of 2021, depending on trial enrollment and occurrence of COVID-19 cases in the study.

    Joshua Liang, Chief Executive Officer of Clover Biopharmaceuticals, said, "Dosing the first participants in SPECTRA marks another significant milestone in our journey to develop a COVID-19 vaccine. There is still a significant need in many global communities for COVID-19 vaccines and should the Phase 2/3 interim analysis be favorable, we will work closely with regulatory authorities worldwide to make our S-Trimer COVID-19 vaccine candidate available as soon as possible."

    Ryan Spencer, Chief Executive Officer of Dynavax, commented, "We are excited to see the first participants dosed in SPECTRA, providing an opportunity for Clover's protein subunit vaccine candidate adjuvanted with CpG 1018 to demonstrate safety and efficacy. Clover's adjuvanted vaccine candidate has the potential to be an important additional solution to address worldwide demand since it can be manufactured at large scale and stored at standard refrigeration temperature. We are proud to be collaborating with Clover on the development of this vaccine for COVID-19 and committed to supporting Clover in making the vaccine available globally."

    SPECTRA is fully funded by the Coalition for Epidemic Preparedness Innovations (CEPI). Through this collaboration, hundreds of millions of adjuvanted S-Trimer vaccine doses will potentially be made available for procurement and allocation through the COVAX Facility to protect the most at-risk populations in participating countries.

    Dr. Richard Hatchett, Chief Executive Officer of CEPI commented: "This is an important step forward in the development of Clover's promising vaccine candidate, which could give us a much-needed additional tool to help control the spread of COVID-19. If the vaccine is proven to be safe and effective, we hope to make hundreds of millions of doses globally accessible through COVAX."

    In December 2020, Clover reported positive clinical data from its Phase 1 trial demonstrating that its protein-based COVID-19 S-Trimer vaccine candidate in combination with Dynavax's CpG 1018 induces strong immune response, including neutralizing antibodies and cell-mediated immunity, as well as favorable safety and tolerability profiles in the adult and elderly participants. The vaccine candidate is expected to be stable long term under standard refrigeration conditions and has demonstrated stability at room temperature for at least two months, making it suitable for global distribution. 

    The Phase 1 data was shared in The Lancet in early 2021.

    About S-Trimer COVID-19 Vaccine Candidate

    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 biotechnology company developing transformative biologics as vaccines and therapeutics for the world's most debilitating diseases. By leveraging its proprietary Trimer-Tag© platform, Clover has developed a protein-based COVID-19 vaccine candidate. Clover expects to utilize its in-house cGMP biomanufacturing capabilities to potentially produce and broadly distribute hundreds of millions of COVID-19 vaccine doses annually to those who need it most around the globe. Clover's lead oncology asset, SCB-313, is in multiple ongoing Phase I clinical trials in Australia and China. Clover expects to advance multiple new pipeline products to the clinic and continues to discover, develop and deliver innovative and affordable medical solutions to improve the quality of life and wellbeing of patients around the world. Clover has corporate offices in Chengdu, Changxing, Shanghai and Beijing in China and expects to open a U.S. headquarters in Boston in the first half of 2021. Since 2020, Clover has raised more than USD $400 million and has built strong partnerships with internationally renowned healthcare organizations. For more information, please visit our website:  www.cloverbiopharma.com  and follow the company on LinkedIn.

    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) and the European Commission. 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. and Europe 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.

    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 11 partnerships to develop vaccines against the novel coronavirus. The programmes are leveraging 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).

    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 initiating clinical trials and completing development, whether CpG 1018 plus aluminum combined with Clover's protein subunit vaccine will prove to be beneficial in clinical trials, whether and when the vaccine will be approved for use, whether CEPI will continue to fund the Clover program through development and licensure, and whether sufficient quantities of CpG 1018 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, 2020, 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.

    Clover Biopharmaceuticals Contact:

    Cindy Min

    Vice President, Public Affairs

    Media Contact:

    Katelyn Caruso-Sharpe

    LifeSci Communications

    Dynavax 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/clover-biopharmaceuticals-and-dynavax-announce-first-participants-dosed-in-spectra-a-global-phase-23-clinical-trial-for-adjuvanted-s-trimer-covid-19-vaccine-candidate-301254841.html

    SOURCE Dynavax Technologies

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    • Over 22,000 participants aged 18 years or older are expected to be enrolled in SPECTRA across Latin America, Asia, Europe and Africa
    • Interim analysis of the primary endpoint expected in the middle of 2021

    CHENGDU, China and EMERYVILLE, Calif., March 24, 2021 /PRNewswire/ -- Clover Biopharmaceuticals (Clover), a global clinical-stage biotechnology company developing transformative biologics such as vaccines and therapeutics for the world's most debilitating diseases, and Dynavax Technologies Corporation ((Dynavax, NASDAQ:DVAX), a biopharmaceutical company focused on developing and commercializing novel vaccines, today announced the first participants have been dosed in Clover's SPECTRA trial (Study Evaluating Protective-Efficacy and Safety of…

    • Over 22,000 participants aged 18 years or older are expected to be enrolled in SPECTRA across Latin America, Asia, Europe and Africa
    • Interim analysis of the primary endpoint expected in the middle of 2021

    CHENGDU, China and EMERYVILLE, Calif., March 24, 2021 /PRNewswire/ -- Clover Biopharmaceuticals (Clover), a global clinical-stage biotechnology company developing transformative biologics such as vaccines and therapeutics for the world's most debilitating diseases, and Dynavax Technologies Corporation ((Dynavax, NASDAQ:DVAX), a biopharmaceutical company focused on developing and commercializing novel vaccines, today announced the first participants have been dosed in Clover's SPECTRA trial (Study Evaluating Protective-Efficacy and Safety of Clover's Trimeric Recombinant Protein-based and Adjuvanted COVID-19 Vaccine), a global Phase 2/3 clinical trial evaluating the efficacy, safety and immunogenicity of  Clover's protein-based S-Trimer COVID-19 vaccine candidate adjuvanted with Dynavax's CpG 1018 plus alum.

    Logo (PRNewsfoto/Clover Biopharmaceuticals)

    The global Phase 2/3 trial is a double-blind, randomized, controlled study of the adjuvanted S-Trimer COVID-19 vaccine candidate in a two-dose regimen, given 21 days apart. The study is expected to enroll over 22,000 adult and elderly participants at multiple sites across Latin America, Asia, Europe and Africa. An independent external Data Safety Monitoring Board (DSMB) will provide safety oversight throughout the program by regular review of available efficacy and safety data. An interim analysis of the primary endpoint is expected in the middle of 2021, depending on trial enrollment and occurrence of COVID-19 cases in the study.

    Joshua Liang, Chief Executive Officer of Clover Biopharmaceuticals, said, "Dosing the first participants in SPECTRA marks another significant milestone in our journey to develop a COVID-19 vaccine. There is still a significant need in many global communities for COVID-19 vaccines and should the Phase 2/3 interim analysis be favorable, we will work closely with regulatory authorities worldwide to make our S-Trimer COVID-19 vaccine candidate available as soon as possible."

    Ryan Spencer, Chief Executive Officer of Dynavax, commented, "We are excited to see the first participants dosed in SPECTRA, providing an opportunity for Clover's protein subunit vaccine candidate adjuvanted with CpG 1018 to demonstrate safety and efficacy. Clover's adjuvanted vaccine candidate has the potential to be an important additional solution to address worldwide demand since it can be manufactured at large scale and stored at standard refrigeration temperature. We are proud to be collaborating with Clover on the development of this vaccine for COVID-19 and committed to supporting Clover in making the vaccine available globally."

    SPECTRA is fully funded by the Coalition for Epidemic Preparedness Innovations (CEPI). Through this collaboration, hundreds of millions of adjuvanted S-Trimer vaccine doses will potentially be made available for procurement and allocation through the COVAX Facility to protect the most at-risk populations in participating countries.

    Dr. Richard Hatchett, Chief Executive Officer of CEPI commented: "This is an important step forward in the development of Clover's promising vaccine candidate, which could give us a much-needed additional tool to help control the spread of COVID-19. If the vaccine is proven to be safe and effective, we hope to make hundreds of millions of doses globally accessible through COVAX."

    In December 2020, Clover reported positive clinical data from its Phase 1 trial demonstrating that its protein-based COVID-19 S-Trimer vaccine candidate in combination with Dynavax's CpG 1018 induces strong immune response, including neutralizing antibodies and cell-mediated immunity, as well as favorable safety and tolerability profiles in the adult and elderly participants. The vaccine candidate is expected to be stable long term under standard refrigeration conditions and has demonstrated stability at room temperature for at least two months, making it suitable for global distribution.  The Phase 1 data was shared in The Lancet in early 2021.

    About S-Trimer COVID-19 Vaccine Candidate

    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 biotechnology company developing transformative biologics as vaccines and therapeutics for the world's most debilitating diseases. By leveraging its proprietary Trimer-Tag© platform, Clover has developed a protein-based COVID-19 vaccine candidate. Clover expects to utilize its in-house cGMP biomanufacturing capabilities to potentially produce and broadly distribute hundreds of millions of COVID-19 vaccine doses annually to those who need it most around the globe. Clover's lead oncology asset, SCB-313, is in multiple ongoing Phase I clinical trials in Australia and China. Clover expects to advance multiple new pipeline products to the clinic and continues to discover, develop and deliver innovative and affordable medical solutions to improve the quality of life and wellbeing of patients around the world. Clover has corporate offices in Chengdu, Changxing, Shanghai and Beijing in China and expects to open a U.S. headquarters in Boston in the first half of 2021. Since 2020, Clover has raised more than USD $400 million and has built strong partnerships with internationally renowned healthcare organizations. For more information, please visit our website:  www.cloverbiopharma.com  and follow the company on LinkedIn.

    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) and the European Commission. 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. and Europe 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.

    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 11 partnerships to develop vaccines against the novel coronavirus. The programmes are leveraging 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).

    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 initiating clinical trials and completing development, whether CpG 1018 plus aluminum combined with Clover's protein subunit vaccine will prove to be beneficial in clinical trials, whether and when the vaccine will be approved for use, whether CEPI will continue to fund the Clover program through development and licensure, and whether sufficient quantities of CpG 1018 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, 2020, 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.

    Clover Biopharmaceuticals Contact:

    Cindy Min

    Vice President, Public Affairs

    Media Contact:

    Katelyn Caruso-Sharpe

    LifeSci Communications

    Dynavax Contacts:

    Nicole Arndt, Senior Manager, Investor Relations



    510-665-7264


    Derek Cole, President

    Investor Relations Advisory Solutions

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