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– The global phase 2/3 SPECTRA trial recruited more than 30,000 adult and elderly participants on 4 continents; 100% of SARS-CoV-2 strains observed in the efficacy analysis were variants
– 100% effectiveness against severe COVID-19 and hospitalizations, and 84% effectiveness against moderate to severe COVID-19 caused by any strain of SARS-CoV-2
– Favorable safety profile; no significant difference in systemic adverse events or serious / serious adverse events compared to placebo
– Impressive efficacy and safety results reflect the beneficial profile of CpG 1018 as a valuable vaccine adjuvant
EMERYVILLE, California., September 22, 2021 / PRNewswire / – Dynavax Technologies Corporation (Nasdaq: DVAX), a biopharmaceutical company focused on vaccine development and commercialization, today announced that Clover Biopharmaceuticals (Clover) has reported positive data for its COVID-19 vaccine candidate protein-based, SCB-2019 (CpG 1018 / Alum) adjuvanted with CpG 1018 adjuvant from Dynavax, which met the primary and secondary efficacy endpoints of SPECTRA, a global pivotal phase 2 clinical trial / 3 which recruited more than 30,000 participants. The vaccine’s efficacy has been successfully demonstrated in an environment where 100% of the SARS-CoV-2 strains observed in the efficacy analysis were variants.
Clover reported the following data from its Phase 2/3 SPECTRA trial in a published press release September 22, 2021. SCB-2019 (CpG 1018 / Alum) has demonstrated 100% efficacy against severe COVID-19 and hospitalizations and 84% efficacy against moderate to severe COVID-19 caused by any strain of SARS- CoV-2. SCB-2019 (CpG 1018 / Alum) has demonstrated an overall efficacy of 79% against COVID-19 of any severity caused by the globally dominant Delta variant. Efficacy was 92% against the Gamma variant and 59% against the Mu variant, and collectively these three strains (Delta, Gamma and Mu) accounted for 73% of all strains identified in the study. The overall efficacy was 67% against COVID-19 of any severity caused by any strain in the study, successfully meeting the primary endpoint of the trial. Clover’s vaccine candidate is one of the first to demonstrate significant efficacy against Delta in a randomized, double-blind clinical trial.
SCB-2019 (CpG 1018 / Alum) has demonstrated a favorable safety profile. Serious and serious adverse events (AEs) were infrequent and balanced between the vaccine and placebo groups. Solicited local AEs were mostly mild and transient injection site pain and decreased in frequency after the second dose. It is important to note that the frequency of monitored solicited systemic AEs (fatigue, headache, muscle pain, joint pain, loss of appetite, nausea, chills, fever) was similar between the vaccine and placebo groups.
Ryan spencer, CEO of Dynavax said, “We are very pleased with the reported efficacy results demonstrated in the SPECTRA trial, especially since all cases were from variants. In addition to the positive efficacy results, the remarkable tolerability profile of the adjuvanted Clover vaccine with CpG 1018 could be a useful tool to overcome vaccine reluctance for more reactogenic platforms and for booster doses in the future. We believe these test results demonstrate the value of our adjuvant CpG 1018 as part of the response to this pandemic and as a platform for the development of new and improved vaccines. We look forward to continuing to support Clover and the development of their COVID-19 vaccine, making it available to those in need around the world.
Additional data from SPECTRA’s final analysis has been made available in a presentation that can be viewed on the Clover corporate website. Clover intends to submit the results of the trial to a peer-reviewed publication.
Clover plans to submit applications for conditional approval to global regulatory authorities, including from China National Medical Products Administration, European Medicines Agency and World Health Organization (WHO) in the fourth quarter of 2021. Subject to obtaining conditional approval, Clover plans to begin the initial launch of the SCB- product. 2019 (CpG 1018 / Alum) potentially by the end of 2021. Subject to receiving the WHO Emergency Use List (EUL), Clover plans to deliver up to 414 million doses of its vaccine COVID-19 candidate globally via the COVAX facility, as previously announced.
SPECTRA (Study Evaluating Protective-Efficacy and Safety of Clover’s Trimeric Recombinant Protein-based and Adjuvanted COVID-19 Vaccine) is Clover’s double-blind, randomized, placebo-controlled study on SCB-2019 (CpG 1018 / Alum) administered in two dosing regimens, 21 days apart. Global recruitment has surpassed 30,000 participants aged 18 or older in five countries on four continents, resulting in one of the most ethnically diverse COVID-19 clinical trials to date, including 49% of participants Asia, 45% of Latin America and the rest of Europe and Africa.
About CpG 1018 Adjuvant
CpG 1018 is the adjuvant used in HEPLISAV-B. Dynavax developed the adjuvant CpG 1018 to provide an enhanced vaccine immune response, which has been demonstrated in HEPLISAV-B. CpG 1018 adjuvant provides well-developed technology and an important safety database, potentially accelerating the development and large-scale manufacture of a COVID-19 vaccine.
About Dynavax
Dynavax is a commercial-stage biopharmaceutical company that develops and markets new vaccines. The Company’s first commercial product, HEPLISAV-B® [Hepatitis B Vaccine (Recombinant), Adjuvanted], is approved in the United States and Europe for the prevention of infection with all known subtypes of the hepatitis B virus in adults 18 years of age and older. Dynavax is also advancing CpG 1018 adjuvant as an advanced vaccine adjuvant through research collaborations and partnerships. Current collaborations focus 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 expected results of an ongoing contractual relationship and expected business results. Forward-looking statements can generally be identified by the use of words such as “anticipate”, “believe”, “continue”, “could”, “estimate”, “expect”, “anticipate”, “intend”. “,” “May”, “plan”, “project”, “potential”, “seek”, “should”, “think”, “will”, “would” and similar expressions, or they can use future dates . Forward-looking statements contained in this document include, without limitation, statements regarding our expectations regarding the results of ongoing collaborations and contractual relationships, the timing of regulatory approvals and product launch, our ability to reallocate certain quantities of CpG 1018 to different programs and our expected financial performance. These forward-looking statements are subject to assumptions, risks and uncertainties which may change at any time, and readers are therefore cautioned that actual results may vary. t differ materially from those expressed in forward-looking statements. Factors that could cause actual results to differ include, but are not limited to: risks and uncertainties associated with actual results of clinical trials conducted by Clover and our other associates; if and when Clover’s vaccine will be approved for use and launched; whether sufficient quantities of CpG 1018 can be made; whether or how much Gavi or other business customers buy from Clover; and other risks and uncertainties discussed in documents filed by the Company with the SEC, including the “Risk Factors” sections of the Company’s quarterly report on Form 10-Q for the quarter ended. June 30, 2021. The Company assumes no obligation to update forward-looking statements as a result of new information, future developments or otherwise, except as expressly required by law. All forward-looking statements contained in this document are qualified in their entirety by this cautionary statement.
Contacts:
Nicole arndt, Investor Relations
[email protected]
510-665-7264
Derek cole, President
Investor Relations Consulting Solutions
[email protected]
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SOURCE Dynavax Technologies
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