AstraZeneca will provide $20 million to fund clinical trials with TLF-9 agonist to the end of Phase IIa.
Dynavax Technologies will receive a $3 million payment from AstraZeneca to fund the initiation of clinical trials with their partnered asthma drug AZD 1419. The payment comes as part of the firms’ amended collaboration to accelerate the start of clinical development of the second-generation TLR-9 agonist. Dynavax will manage the early clinical development of AZD 1419, but development expenses will be fully funded by AstraZeneca, which will provide its partner with about $20 million to cover the costs of clinical studies through to the completion of Phase IIa. The firms aim to start a Phase I study after regulatory requirements have been met and clinical materials released.
Under terms of the original and amended deal, Dynavax could receive another $20 million if AstraZeneca decides to progress development of AZD 1419 following completion of Phase IIa studies, plus additional milestones of some $100 million, and royalties on future worldwide sales. Dynavax also retains the option to co-promote AZD 1419 in the U.S.
The firms established an agreement in 2006 focused on developing TLR-9-based agonists against asthma and COPD, including AZD 1419. The program is based on Dynavax’ TLR-9 agonist immunostimulatory sequences platform, which comprises short DNA sequences designed to activate the innate immune response by specifically targeting toll-like receptors (TLRs).
Dynavax’ in-house and partnered pipeline is headed by the Phase III-stage hepatitis B vaccine, Heplisav™, which combines the hepatitis B surface antigen (HBsAg) with a TLR9 agonist to enhance the immune response. Early clinical-stage products include a universal flu vaccine (partnered with Novartis), and hepatitis B and hepatitis C therapeutic candidates.