PLATFORM
The PBS Vax™ Platform
Tailoring the immune response to the target
 
Profectus 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 that are not addressable using current vaccine approaches, emerging infectious diseases of public health and biodefense importance, and difficult-to-treat and advanced-stage cancers.
  • The power of Profectus’ 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 Profectus 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.
  • Profectus' 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.
  • Advanced-stage cancers for which oncolytic vaccines for cancer immunotherapy hold great promise through their ability to selectively destroy tumors while simultaneously boosting patients’ immune systems to continue killing residual cancer cells.
  • Working with pharmaceutical and biotechnology partners, Profectus is also pursuing application of the PBS Vax™ platform to create new vaccines and to transform the performance of existing and pipeline vaccines by enabling them to achieve greater immunogenicity.
PBS Vax™ vaccines represent the next stage in the evolution of therapeutic and prophylactic vaccines. The power of this platform lies in the flexibility to tailor immune responses to specific targets. 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
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
Profectus’ VesiculoVax™ vectors are negative-strand, non-segmented RNA viruses that have been modified to enable the 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 Profectus 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. Preclinical efficacy has also been demonstrated for Vesiculovax vectors against chikungunya virus and the Western, Eastern, and Venezuelan encephalitic alphaviruses in animal models of disease.

PBSVax® Vaccines: DNA Priming Followed by VesiculoVax™ Boosting
Profectus 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. Profectus 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 Profectus 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 HIV, HPV, HBV, HCV and HSV-2.

PBS Vax™ Platform Validation
Profectus has advanced the vaccine components of the PBS Vax™ platform 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 a dose-escalation clinical trial for HIV-1 that demonstrated safety, 100% vaccine take, and immunogenicity across a range of doses. A second immunologically distinct vesiculovirus vector developed by Profectus 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 protection of non-human primates against hemorrhagic fever viruses such as Ebola, Marburg, and Lassa, and is the only vaccine to have demonstrated single-dose protection of monkeys against lethal challenge with highly virulent, low-passage Ebola and Marburg viruses in NIH conducted studies.
  • 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.
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