At a celebration in IHV's light-filled multi-level atrium on Lombard Street, O'Malley thanked those supporting the research. "Through your generosity and vision you are making this place not only a beacon of hope, but a real powerful force of healing. It makes us understand we are a part of something much bigger than ourselves by being here today.
"There's a beautiful Talmudic saying that if you save just one life it's as if you've saved the world," he continued. "Imagine the lives that we have the ability, the potential, the blessing, to be able to touch through the great work that Dr. [Robert] Redfield, Dr. [William] Blattner, Dr. [Robert] Gallo and all of you here at this institute are doing."
The funding is to support further preclinical development and Phase I/II clinical trials of a novel HIV vaccine candidate developed by the research team at IHV. The candidate immunogen, denoted as FLSC (Full-Length Single Chain), is designed to elicit strongly protective antibody responses across the spectrum of HIV-1 strains. Research will be conducted by IHV, led by Dr. Gallo, director of IHV, and joined by investigators from Sanofi Pasteur and the Military HIV Research Program.
University of Maryland President Jay A. Perman, MD, said the cutting-edge research at IHV is a source of pride but isn't surprising."I can't think of any other place in the world where they could assemble as much knowledge about HIV in a single room as a staff meeting here at this institute," he told the crowd. "What Dr. Gallo and his team are doing really represents unbridled hope. Not just for the millions of people currently living with HIV AIDS, but hope for future generations who might never have to know the scourge of this disease."
Grants provided by the consortium will allow for clinical testing of FLSC evaluating immune response and safety in humans, and optimization of the prime-boost vaccination strategy. The research is specifically designed to determine if the immune responses elicited by the vaccine candidate are sufficiently powerful and long-lasting in humans. The research will also assess prime-boost combinations of the HIV vaccine developed by Sanofi Pasteur (ALVAC), which recently demonstrated modest protection in an efficacy trial conducted by the MHRP in Thailand, coupled with the FLSC developed by the institute. Both vaccine candidates involve use of a modified form of the outer protein envelope, allowing each to potentially complement the use of the other.
"The Gates Foundation worked closely with Dr. Gallo's team in the design and review of this innovative approach to an HIV vaccine," said Jose Esparza, MD, PhD, senior advisor on HIV Vaccines for the foundation's Collaboration for AIDS Vaccine Discovery project. "We are proud to support Dr. Gallo's continued, pioneering work in HIV and AIDS."
The Gates Foundation's assessment of the promising potential of IHV's preventive vaccine candidate was shared by the MHRP. "The U.S. Military HIV Research Program, part of the Walter Reed Army Institute of Research [WRAIR] and working with the Henry M. Jackson Foundation for the Advancement of Military Medicine, is very pleased to be part of this exciting research effort to develop a globally effective HIV vaccine," said Col. Peter Weina, PhD, MD, FACP, deputy commander of WRAIR.
E. Albert Reece, MD, PhD, MBA, vice president for medical affairs at the University and dean of the School of Medicine, hosted the event and was clearly proud of the work of the institute. "IHV has extended the boundaries of biomedical knowledge and discovery. It is changing the notion of how that science is applied in the world. IHV is taking its science directly to the communities who need it most here in Baltimore and around the world. IHV has affiliates and partners around the world that are leading the fight against HIV AIDS, including centers in eight African nations, two Caribbean nations, China, and numerous other countries worldwide. This is indeed a global institute working locally but certainly having a worldwide impact."
The novel prime-boost strategy using FLSC is distinguished by its potential ability to induce broad antibody responses to HIV-1. The antibodies induced by the experimental vaccine bind to common HIV regions that are exposed when the virus attaches to target cells, rather than to specific characteristics of the HIV envelope protein that may not be present in all virus strains. That strategy could potentially overcome limitations of previous vaccine candidates that responded to single strains or narrow ranges of HIV viruses.
"IHV's unique and promising HIV/AIDS vaccine candidate is designed to bind to the virus at the moment of infection, when many of the different strains of HIV found around the world can be neutralized," said Gallo, widely known for his discovery of the first human retroviruses (including one that causes a specific kind of leukemia), co-discovery of HIV, and the development of the HIV blood test. "We believe this mechanism is a major prerequisite for an effective HIV preventive vaccine."
Gallo acknowledged and expressed appreciation to the institute's entire team, noting especially the original contributions of IHV's Tony DeVico, PhD, and co-principal investigator George Lewis, PhD, for their work on the development of FLSC. He also indicated that he was looking forward to advancing the next phases of research in conjunction with IHV Associate Director, Dr. Redfield, and his Clinical Care and Research Division at the institute.
Baltimore-based Profectus Biosciences, a spinoff company from IHV, will be leading the preclinical development of the vaccine construct. Sanofi Pasteur was represented at the IHV celebration by Sanjay Gurunathan, MD, head of clinical development.
"This is an exceptional combination of research partners-IHV, Sanofi Pasteur, Profectus Biosciences, and the Military HIV Research Program-and we are grateful for the extraordinary support from all of our funding partners, including the Gates Foundation, the U.S. Army, and NIH," said Gallo. "This team is truly dedicated to eradicating HIV and AIDS, and we are excited by the potential for accomplishing that goal with the use of our novel prime-boost immunization strategy."
Since its founding in 1996, IHV has been a world leader in HIV/AIDS research and treatment, with a proven track record of bringing medical benefits to people living with HIV/AIDS in the United States and around the world.