Dynavax and Serum Institute of India Announce First Participant Dosed in a Phase 1 Clinical Trial Evaluating an Improved Tdap Vaccine Adjuvanted with CpG 1018
EMERYVILLE, Calif. and PUNE, India, Feb. 4, 2021 /PRNewswire/ -- Dynavax Technologies Corporation (Nasdaq: DVAX), a biopharmaceutical company focused on developing and commercializing novel vaccines, and Serum Institute of India, Ltd. (SIIPL), the largest vaccine manufacturer in the world by doses, today jointly announced that the first participant has been dosed in a Phase 1 clinical trial evaluating a tetanus, diphtheria, and acellular pertussis (Tdap) booster vaccine candidate adjuvanted with CpG 1018.
Dynavax and SIIPL are collaborating to develop an adjuvanted Tdap vaccine to address the shortcomings of the currently marketed acellular pertussis vaccines. Incidence of pertussis infection in the U.S. and other industrialized countries has been rising since the switch from whole cell pertussis to acellular pertussis vaccines in the 1990s. Although currently marketed acellular pertussis vaccines are effective at providing initial protection from disease, rates of pertussis continue to rise due to waning immunity over time. These vaccines may not prevent the pertussis bacteria from colonizing in the patient, potentially allowing previously vaccinated, asymptomatic individuals to spread the disease. This vaccine candidate has the potential to provide an alternative to the current booster dose given at 10 years of age and older with the goal of increasing the durability of the immune response and reducing transmission from vaccinated individuals who may still spread the disease even if they are asymptomatic.
"The development of a CpG 1018 adjuvanted Tdap vaccine is an important pipeline product for Dynavax which continues to leverage the value of CpG 1018, the adjuvant included in our FDA licensed 2-dose adult hepatitis B vaccine," commented Ryan Spencer, Chief Executive Officer of Dynavax. "With our proven adjuvant technology and SIIPL's antigen manufacturing capabilities, this program provides a unique opportunity to advance our goal of developing improved vaccines to address important unmet needs globally."
Sharing his thoughts, Mr. Adar Poonawalla, CEO, Serum Institute of India, said, "Our partnership with Dynavax is an important step towards addressing the resurgence of Pertussis. Addition of CpG 1018 adjuvant to our Tdap vaccine will ensure the development of this much needed improved Acellular pertussis-based combination vaccine to protect the children, adolescents and adults in the developed world. Even though there is a lot to be done before the vaccine is fully developed, this marks a key step towards a promising and healthy future."
The Phase 1 randomized, open label, active-controlled, dose escalation clinical trial will evaluate the safety, tolerability, and immunogenicity of the vaccine candidate, adjuvanted with CpG 1018, in healthy volunteers 10 to 22 years of age. Dynavax anticipates results from the Phase 1 study to be available in the fourth quarter of 2021.
Under the collaboration, Dynavax has exclusive world-wide rights to commercialize the vaccine, except that SII has exclusive rights to distribute in India and to fulfill WHO/UNICEF tender contracts. The parties are responsible for clinical development cost in their respective territories.
Reported pertussis incidence has been increasing in the United States and other industrialized countries using the acellular vaccine since the late 1980s and early 1990s, with large epidemic peaks in disease observed since the mid-2000s. A total of 48,277 US pertussis cases were reported in 2012, the largest number reported since the mid-1950s. There are likely many factors contributing to the observed increase in reported disease. These include changes in diagnostic testing, heightened recognition and reporting of pertussis cases, and molecular changes in the organism. However, waning of vaccine-induced immunity and asymptomatic transmission from vaccinated individuals is thought to play a key role in countries, including the United States, that transitioned to acellular vaccines in the 1990s. iii
The U.S. Centers for Disease Control (CDC) recommends the Tdap vaccine for all children 7 years and older, adolescents from 11-12 years of age, pregnant women (during the 3rd trimester) and adults who have never been received Tdap, also adults should receive a booster dose every 10 years, because they are often the source of infection for infants.iv
About CpG 1018
About Serum Institute of India Pvt. Ltd.
Serum Institute is developing biosimilars of existing antibody immunotherapies for a range of diseases, and in 2017 launched a novel monoclonal antibody against rabies.
Dynavax Forward-Looking Statements
Derek Cole, President
View original content to download multimedia:http://www.prnewswire.com/news-releases/dynavax-and-serum-institute-of-india-announce-first-participant-dosed-in-a-phase-1-clinical-trial-evaluating-an-improved-tdap-vaccine-adjuvanted-with-cpg-1018-301221836.html
SOURCE Dynavax Technologies
Company Codes: NASDAQ-SMALL:DVAX