Commercial stage novel vaccine developer Dynavax Technologies Corp. (DVAX:NASDAQ), today announced that "Clover Biopharmaceuticals reported positive data for their protein-based COVID-19 vaccine candidate, SCB-2019 (CpG 1018/Alum) adjuvanted with Dynavax's CpG 1018 adjuvant, which achieved the primary and secondary efficacy endpoints in SPECTRA, a global pivotal Phase 2/3 clinical trial that enrolled over 30,000 participants."
The company highlighted that the vaccine efficacy results measured in the Phase 2/3 SPECTRA study were quite significant and impressive. The firm noted that the vaccine was shown to be effective in an environment where all the SARS-CoV-2 strains observed in the efficacy analysis were COVID-19 variants.
Dynavax Technologies reported that Clover Biopharmaceuticals reported in a separate news release today that in the Phase 2/3 SPECTRA study, "SCB-2019 (CpG 1018/Alum) 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."
Drilling down further, Clover indicated that in the study, SCB-2019 (CpG 1018/Alum) demonstrated a 79% overall efficacy against the COVID-19 Delta variant, 92% efficacy against the Gamma variant and 59% against the Mu variant.
The Delta, Gamma, and Mu variant strains accounted for 73% of all strains identified amongst participants during the study. Clover reported that SCB-2019 (CpG 1018/Alum) registered an overall efficacy rate of 67% against COVID-19 of any severity caused by any strain in the study, thereby successfully meeting the trial's pre-established primary endpoint. The report noted that "Clover's vaccine candidate is one of the first to demonstrate significant efficacy against Delta in a double-blind, randomized clinical trial."
Dynavax Technologies' CEO Ryan Spencer remarked, "We are very pleased with the reported efficacy results demonstrated in the SPECTRA trial, especially considering that all cases were from variants. In addition to the positive efficacy results, the remarkable tolerability profile of the Clover vaccine adjuvanted with CpG 1018 could be a useful tool in overcoming vaccine hesitancy for more reactogenic platforms and for booster doses in the future. We believe these trial results demonstrate the value of our CpG 1018 adjuvant as part of the response to this pandemic and as a platform for the development of new and improved vaccines."
According to the announcement today from Dynavax, in Q4/21 Clover intends to submit several conditional approval applications world health regulatory bodies including China's National Medical Products Administration, the European Medicines Agency, and the World Health Organization (WHO).
If it is successful in securing emergency use and conditional approvals from these groups, the company plans to make the product available commercially by year-end 2021. The vaccine rollout plans currently provide for up to 414 million doses of its COVID-19 vaccine candidate to be manufactured and distributed worldwide though the COVAX facility.
The Phase 2/3 SPECTRA study was designed to evaluate the safety and efficacy of Clover's SCB-2019 (CpG 1018/Alum) vaccine. The study was conducted in 30,000 adult participants 18 year of age or older across Africa, Asia, Europe, and Latin America. The vaccine was tested with two separate doses that were administered 21 days apart.
Dynavax explained that it developed CpG 1018 as an adjuvant to deliver an increased vaccine immune response as has been demonstrated in its Hepatitis B Vaccine, HEPLISAV-B®. The company stated that its CpG 1018 adjuvant utilizes well-developed technology to potentially aid in accelerating development and large-scale manufacturing of a COVID-19 vaccine.
Dynavax is a commercial stage biopharma firm based in Emeryville, Calif. The company focuses its efforts on developing and commercializing cutting-edge, novel vaccines. The firm's Hepatitis B Vaccine, HEPLISAV-B®, has been approved in both the U.S. and Europe for prevention of infection caused by all known subtypes of hepatitis B virus in adult patients. In addition to its work advancing CpG 1018 adjuvant with Clover Biopharmaceuticals, the company is also collaborating with its partners to develop adjuvant vaccines for pertussis and universal influenza.
Dynavax started the day with a market cap of around $1.7 billion with approximately 114.8 million shares outstanding and a short interest of about 20%. DVAX shares opened over 6% higher today at $15.80 (+$0.94, +6.33%) over yesterday's $14.86 closing price and reached a new 52-week high of $20.66. The company's stock traded today between $15.77 and $20.66 per share and closed at 18.79 (+$3.93, +26.45%).
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