Dynavax and CEPI Announce $99 Million in Funding for CpG 1018 Adjuvant Manufacturing to Support the Global COVID-19 Response

Rhea-AI Summary

Dynavax Technologies Corporation (Nasdaq: DVAX) announced a partnership with the Coalition for Epidemic Preparedness Innovations (CEPI) to supply its CpG 1018 adjuvant for COVID-19 vaccines. CEPI will provide up to $99 million in funding through a forgivable loan to support the manufacturing of CpG 1018. This agreement aims to enhance vaccine efficacy and ensure equitable access globally. The stockpiled adjuvant will be available for CEPI grantees, with reimbursement obligations tied to sales. This collaboration underscores CpG 1018's potential role in addressing the pandemic.

Positive

• Dynavax secures up to $99 million in funding from CEPI to support CpG 1018 manufacturing.
• The partnership aims to enhance the development and distribution of effective COVID-19 vaccines.
• CpG 1018's use as an adjuvant may significantly boost vaccine efficacy.

Negative

• The success of the agreement relies on whether CEPI fully funds the $99 million.
• There are uncertainties regarding the commercial uptake of CpG 1018 by vaccine purchasers.
• Risks exist around the potential failure of vaccine programs using CpG 1018, which could result in financial losses for Dynavax.

OSLO, Norway AND EMERYVILLE, Calif., Feb. 1, 2021 /PRNewswire/ -- Dynavax Technologies Corporation (Nasdaq: DVAX), a biopharmaceutical company focused on developing and commercializing novel vaccines, and the Coalition for Epidemic Preparedness Innovations (CEPI) today announced they have entered into an agreement to support the supply of Dynavax's CpG 1018 advanced adjuvant to be used in approved COVID-19 vaccines developed by CEPI grantees.

Dr. Richard Hatchett, CEO of CEPI commented: "A critical goal of CEPI's response to COVID-19 is to support development, manufacturing and distribution of vaccines to end the acute phase of the pandemic by the end of 2021. Through our partnership with Dynavax, we hope to enable the development and faster supply of adjuvanted COVID-19 vaccines and ensure equitable access to them globally."

"CEPI has been instrumental in supporting vaccine development to address the COVID-19 pandemic," commented Ryan Spencer, Chief Executive Officer of Dynavax. "Adjuvants will play an important role in developing effective vaccines for COVID-19 and we are proud to contribute to CEPI's efforts in this global public health emergency with our CpG 1018 advanced adjuvant platform. This funding will ensure the capacity is available to help meet global health needs. This agreement is reflective of CpG 1018's potential significant benefit around the world in vaccines for COVID-19."

Under the terms of the agreement, CEPI will provide Dynavax funding of up to $99 million through a forgivable loan for the manufacturing of CpG 1018 with the potential to support hundreds of million doses of COVID-19 vaccine for delivery in 2021 through COVAX. COVAX is the global initiative to ensure rapid and equitable access to COVID-19 vaccines for all countries, regardless of income level. This stockpile of CpG 1018 will be first available for purchase by CEPI grantees for use in approved COVID-19 vaccines. Dynavax will sell the reserved CpG 1018 under separate commercial supply agreements made directly with CEPI grantees within price parameters agreed with CEPI. Upon sale of CpG 1018 manufactured under this agreement, Dynavax will reimburse CEPI for the funded manufacturing cost. If the relevant vaccine programs are unsuccessful and no alternative use is found for the adjuvant, the loan will be forgiven.      

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

Dynavax Forward-Looking Statements
This press release contains "forward-looking" statements, including statements regarding the manufacture and sale of CpG 1018 for COVID-19 vaccines and the potential benefits of using CpG 1018 as an adjuvant in COVID-19 vaccines. 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  whether CpG 1018 will prove beneficial in COVID-19 vaccines, whether purchasers will purchase the stockpiled CpG 1018 and in what quantity,  whether Dynavax will be able to manufacture sufficient quantities of CpG 1018 to meet demand, and whether CEPI will fund the full $99 million for manufacturing, 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.

Dynavax Contacts:
Nicole Arndt, Senior Manager, Investor Relations
narndt@dynavax.com
510-665-7264

Derek Cole, President
Investor Relations Advisory Solutions
derek.cole@IRadvisory.com

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SOURCE Dynavax Technologies

FAQ

What is Dynavax's recent agreement with CEPI about?

Dynavax's agreement with CEPI involves supplying CpG 1018 adjuvant for COVID-19 vaccines with funding of up to $99 million.

How much funding has Dynavax received from CEPI?

Dynavax has received up to $99 million from CEPI to support the manufacturing of its CpG 1018 adjuvant.

What are the potential benefits of CpG 1018 in COVID-19 vaccines?

CpG 1018 may enhance the immune response and efficacy of COVID-19 vaccines.

What are the risks associated with Dynavax's agreement with CEPI?

The risks include the possibility of CEPI not fully funding the agreement and uncertainties regarding the success of vaccine programs using CpG 1018.

When was the Dynavax and CEPI agreement announced?

The agreement was announced on February 1, 2021.