A breakthrough vaccine candidate developed by Australia’s QIMR Berghofer Medical Research Institute against the common and potentially dangerous cytomegalovirus, or CMV, will be further developed in collaboration with U.S. based Dynavax Technologies Corporation.
Under the agreement with QIMR Berghofer, Dynavax will have an exclusive option to obtain a license to novel protein antigens from QIMR Berghofer. QIMR Berghofer will receive an option fee, with potential for an option exercise fee, plus potential milestone and royalty payments contingent on regulatory, development and commercial success.
CMV is a herpes virus which is carried by half the population, but the majority will never develop symptoms. A small proportion develop a glandular fever-like illness. However, in pregnant women, CMV is potentially dangerous for their unborn baby and may cause permanent hearing loss, cerebral palsy and even death. The virus is also dangerous for transplant patients due to their compromised immune system.
Despite being a top priority of the U.S. Institute of Medicine, all previous attempts to produce a durable and effective CMV vaccine have failed.
QIMR Berghofer’s breakthrough represents a new approach. Professor Rajiv Khanna, coordinator of the Institute’s Centre for Immunotherapy and Vaccine Development, said previous attempts had failed because they relied on traditional technologies to develop antibodies which attach to and remove the virus.
“CMV is a very complex virus, one of the largest DNA viruses, and it can hide inside cells and escape immune control,” Professor Khanna explained.
“What we have done is to deploy another arm of the immune system, what we call Killer T-Cells, to attack those cells in which the virus is hiding.”
“We are combining both humoral immunity and this killer cellular immunity into a single formulation,” Professor Khanna said.
Extensive preclinical testing of this bivalent vaccine has produced strong neutralising antibody and CMV-specific polyfunctional T cell responses. The QIMR Berghofer team has also successfully developed a process to produce the vaccine’s polyepitope protein. Professor Khanna’s work was recently published in PLOS Pathogens Journal.
Under the option and license agreement, Dynavax will have the option to develop QIMR Berghofer’s polyepitope protein in combination with its proven toll-like receptor 9 agonist CpG 1018® adjuvant.
QIMR Berghofer Director and CEO, Professor Fabienne Mackay congratulated Professor Khanna and his team, and welcomed the option and license agreement, which is hoped will lead to clinical development and ultimately commercialisation of a CMV vaccine.
“This agreement paves the way for enriching the current CMV vaccine pipeline with a new promising candidate to potentially address a significant unmet need, protecting pregnant women and their unborn babies against a dangerous infection. The breakthrough by Professor Khanna’s team, together with the option and license agreement, further underlines the essential role QIMR Berghofer plays in advancing human health around the globe through our leading medical research,” Professor Mackay said.
The next steps in development are to manufacture the proteins, develop the optimal vaccine formulation, and then commence a phase one clinical trial. Professor Khanna’s team will collaborate with Dynavax on future development of the vaccine.
Watch the video to find out more about cytomegalovirus and how this new vaccine approach works.