Tailoring the immune response to the target
Auro Vaccines is pioneering Vaccines 2.0, a major evolutionary step in the design and development of prophylactic and therapeutic vaccines. This is made possible by a proprietary vaccine platform that allows us to quantitatively and qualitatively tailor effective immune responses to targets that represent high unmet medical needs. Our focus is on major chronic infectious diseases and their associated cancers, emerging infectious diseases of public health and biodefense importance, and difficult-to-treat and advanced-stage cancers.
- The power of Auro Vaccines’ proprietary approach lies in the exceptional flexibility of its Prime/Boost System of Vaccines (PBS Vax™) technology, which provides the ability to tailor immune responses to specific targets.
- The Auro Vaccines approach to developing vaccines is transformative, with the potential to generate immune response against intractable diseases for which current approaches are either ineffective or nonexistent.
- Auro Vaccines’ proprietary PBS Vax™ prime/boost platform technology provides exceptional breadth. Our focus is on developing vaccines for the treatment and/or prevention of:
- Major chronic viral infectious diseases and their associated cancers—areas of large unmet need where our technology can have the nearest-term impact with substantial business potential in developed countries.
- Emerging infectious diseases of public health and biodefense importance where there is significant opportunity for global health impact and business success.
PBS Vax™ vaccines represent the next stage in the evolution of therapeutic and prophylactic vaccines. The PBS Vax™ system comprises:
- First-in-class VesiculoVax™ vaccines vectored with attenuated, replication-competent vesiculoviruses
- Best-in-class DNA vaccines enhanced by the co-administration of IL-12 and electroporation delivery
The power of this platform lies in the flexibility to tailor immune responses to specific targets.
- DNA priming followed by VesiculoVax™ boosting enables the development of next-generation therapeutic T cell vaccines for chronic viral diseases and cancers.
- VesiculoVax™ priming followed by VesiculoVax™ boosting enables the development of prophylactic B cell vaccines for acute infectious disease indications.
Vesiculovax™ Virus-Vectored Vaccines
Auro Vaccines’ VesiculoVax™ vectors are negative-strand, non-segmented RNA viruses that have been modified to enable the safe delivery of vaccine immunogens. VesiculoVax™ vectors are particularly effective for a number of reasons, including:
- Unlike adenovirus and other conventional viral vector vaccines, there is little pre-existing immunity in the human population.
- It is a family of vectors that allows the use of a unique vector for each vaccine application.
- They have a relatively simple genome organization that can be altered to accommodate and express more than one foreign gene.
- Multiple clinical trials have shown the prototypical vector to be safe and immunogenic in humans.
- They are replication-competent:
- Allows a highly scalable and cost-effective manufacturing process.
- The replicating vector efficiently activates the immune system via:
- Innate immune signals.
- The release of a cascade of “molecular adjuvants.”
- Used alone, VesiculoVax™ vectored vaccines lead to the rapid expansion of B cells to antibody-producing cells.
- Used as a boost after DNA priming, VesiculoVax™-vectored vaccines lead to expansion of primed T cells into effector T cells that are uniquely suited to attacking virally infected cells and cancers
- These vectors include Vesicular stomatitis virus (VSV) and Isfahan virus; other vectors are under development
Product Example:
First-in-class prophylactic vaccines for emerging infectious diseases of public health and biodefense importance:
VesiculoVax™ priming followed by VesiculoVax™ boosting enables the development of pre-exposure vaccines that amplify B-cell immune response for cases in which the rapid induction of neutralizing antibodies is needed to protect against viruses that cause hemorrhagic fevers, such as Ebola, Marburg, and Lassa viruses. The Auro Vaccines’ prototype VesiculoVax™ vector has demonstrated single-dose protection of monkeys against lethal challenge with Ebola and Marburg viruses in studies conducted by a team from the NIAID, CDC, FDA, and DoD. A series of immunologically distinct VesiculoVax™ vectors have been developed to the point that they have demonstrated protective efficacy in animal models of lethal disease caused by Eastern, and Venezuelan encephalitic alphaviruses, Lassa, CHIK and ZIKA viruses.
PBSVax™ Vaccines: DNA Priming Followed by VesiculoVax™ Boosting
Auro Vaccines DNA priming / VesiculoVax™ boosting represents a significant advance over therapeutic approaches that use DNA vaccines alone to induce T-cell immune responses. DNA vaccines effectively prime T cells for rapid synergistic expansion upon VesiculoVax™ boosting into effector T cells that are uniquely suited to attacking virally infected cells and cancers. Auro Vaccines combines best-in-class DNA vaccines co-administered with human IL-12 (a natural “molecular adjuvant”) and delivery via electroporation to prime the immune system. Specifically, the Auro Vaccines DNA technology overcomes the poor immunogenicity of conventional DNA vaccines by integrating:
- Co-formulation of the DNA plasmids with bupivacaine, a small-molecule anesthetic that stabilizes pDNA vaccines by intercalating with pDNA helix and improving delivery into the target tissue.
- Co-formulating the immunogen-expressing DNA plasmids with a plasmid-expressing the potent molecular adjuvant IL-12, which directs responding T cells down the pathway to becoming T effector cells with the capacity to kill virally infected cells and cancer cells.
- Delivering DNA vaccine formulations via electroporation, which enhances vaccine entry into target cells.
Product Example:
Best-in-class PBS Vax™ therapeutic vaccines for chronic viral infectious diseases.
DNA priming followed by VesiculoVax™ boosting enables the development of next-generation therapeutic T cell vaccines that induce an enhanced and durable T cell-mediated immune response to mitigate disease caused by viruses such as HPV, HBV, HCV and HSV-2.
PBS Vax™ Platform Validation
The vaccine components of the PBS Vax™ platform have been advanced through Phase 1 safety and immunogenicity testing. Data confirm the Profectus PBS Vax™ system is enhancing immune responses in new ways:
- VesiculoVax™ priming followed by VesiculoVax™ boosting has completed several dose-escalation clinical trials for HIV-1 and Ebola. These clinical trials demonstrated safety, 100% vaccine take, and immunogenicity across a range of doses. Isfahan virus, a second immunologically distinct vesiculovirus vector developed by Auro Vaccines in collaboration with the University of Texas Medical Branch at Galeveston has demonstrated protective efficacy in a small animal model of lethal encephalitic disease caused by Venezuelan and Eastern equine encephalitis viruses. VesiculoVax™ viral vector vaccines have demonstrated rapid-onset, single-doseprotection of non-human primates against hemorrhagic fever viruses such as Ebola, Marburg, and Lassa. ,
- DNA priming followed by VesiculoVax™ boosting has completed Phase 1 clinical evaluation as an HIV-1 vaccine. The data demonstrate the safety and tolerability of this technology and confirm that VesiculoVax™ boosting following DNA priming synergistically enhances T cell immune responses beyond those seen with DNA vaccines alone.