PIPELINE
PBS Vax™ Therapeutic Vaccines
for Chronic Infectious Diseases
HIV | HPV | HBV | HCV | HSV-2

For the treatment of chronic infectious diseases, where the induction of a robust cell-mediated immune (CMI) response is required to mitigate disease caused by viruses such as HIV, HPV, HBV, and HCV, Profectus utilizes GeneVax® DNA vaccines delivered with GeneVax IL-12® and electroporation to prime the immune system, followed by a VesiculoVax™ boost to induce durable CMI. This represents a significant advance over DNA vaccines used alone. The phase 1 clinical trial of the Profectus PBS Vax™ prime/boost HIV vaccine has completed dosing of 100 subjects. The data show the safety and tolerability of this vaccination regimen, and confirm that GeneVax® primed CD4 and CD8 T cell responses are synergistically increased by VesiculoVax™ boosting.
CLINICAL-STAGE PBS VAX™ THERAPEUTIC VACCINES
HIV
Studies in non-human primates have demonstrated Profectus’ GeneVax® prime/VesiculoVax™ boost therapeutic HIV vaccine to be uniquely able to induce an immune response of the magnitude and character required by the NIH HIV “Cure Agenda.” In collaboration with the NIH, Profectus has initiated a Phase 1 TheraVax trial in subjects on stable anti-retroviral therapy to determine the extent to which this vaccine can clear the reservoir of silently infected cells that chronically re-seed the infection. The company believes the clinical performance of its HIV therapeutic vaccine will further validate the PBS Vax™ platform and open the door for additional applications in challenging infectious diseases.

Program Status: Phase 1

Unmet Medical Need:
The WHO and UNAIDS estimate that worldwide 35.3 million people are currently infected with HIV and that 2.3 million of these people are in the developed world. Recently it has been demonstrated that by using extreme measures it is possible to eliminate HIV from the body of an infected individual. Current thinking is that a practical cure will combine anti-retroviral drugs to maintain viral control, vaccination to induce an immune response that kills any cell producing virus, and drugs that induce silently infected cells to produce enough virus to trigger immune elimination.

PRECLINICAL-STAGE PBS VAX™ THERAPEUTIC VACCINES
HPV
Profectus is developing a GeneVax® prime/VesiculoVax™ boost therapeutic HPV vaccine for use as an adjunct to surgery that targets the seven HPV types responsible for more than 92% of cervical and head and neck cancers.

Program Status:
Prototype monovalent and bi-valent HPV vaccines have completed immunogenicity testing in NHPs. Final seven valent vaccine designs have entered small animal testing for immunogenicity and down-selection of the lead vaccine will take place in Q2 2014.

Unmet Medical Need:
Cervical cancer is the second leading cause of cancer-related mortality in women worldwide, causing about 470,000 deaths per year. In addition, recent studies have shown the same high risk types of HPV are responsible for most head and neck cancers in both women and men. The currently licensed prophylactic HPV vaccines are not effective as therapeutics in infected subjects.

HBV
Profectus is developing a GeneVax® prime/VesiculoVax™ boost therapeutic vaccine that targets all eight HBV genotypes for use as an adjunct to drug therapy.

Program Status:
Several candidate GeneVax® prime/VesiculoVax™ vaccine combinations are currently being tested in small animals for immunogenicity and down-selection of the lead vaccine will take place in Q2 2014.

Unmet Medical Need:
HBV is the most common cause of serious liver disease in the world. Worldwide over 2 billion people have been infected and 400 million remain chronically infected. More than 1 million people die each year from HBV and its complications. The Profectus GeneVax® prime/VesiculoVax™ boost therapeutic HBV vaccine is designed to be used in conjunction with drug therapy to cure HBV infection.

HCV
Profectus is developing a GeneVax® prime/VesiculoVax™ boost therapeutic vaccine that targets all HCV genotypes for use as an adjunct to drug therapy.

Program Status:
With support from the National Cancer Institute, the lead vaccine has demonstrated robust, broad, and high quality immune responses in non-human primates.

Unmet Medical Need:
Overseas, particularly in Asia, HCV disease is projected to cause an unmanageable burden on global health care over the next 10 to 20 years. Unfortunately, the economies of these many of these nations will not support the cost of the newly developed proprietary drugs for treating HCV infection. The Profectus GeneVax® prime/VesiculoVax™ boost therapeutic HCV vaccine is designed to be used in conjunction with less costly generic drugs to cure HCV infection.

HSV-2
Profectus is developing a GeneVax® prime/VesiculoVax™ boost therapeutic vaccine for herpes simplex virus type-2. This vaccine is designed to ameliorate disease and transmission by preventing HSV-2 reactivation and shedding.

Program Status:
Antigen discovery stage.

Unmet Medical Need:
Herpes simplex virus type 2 is a sexually transmitted virus that causes watery lesions in the skin and mucus membranes of the genitals. It establishes latency in neurons, from where it can sporadically reactivate to cause shedding/transmission with or without new sores. The CDC estimates that 776,000 people in the United States are newly infected each year. Currently, control is only possible with life-long drug treatment.
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