for Chronic Infectious Diseases
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 HPV, HBV, and HCV, Auro Vaccines 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. A phase 1 clinical trial of the Auro Vaccines PBS Vax™ prime/boost HIV vaccine has been completed. 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
HPV
Auro Vaccines 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:
Candidate HPV vaccines have completed immunogenicity testing in NHPs and a final seven valent vaccine design has been down-selected for cGMP manufacture. Phase I clinical testing is anticipated in 2021.
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.
PRECLINICAL-STAGE PBS VAX™ THERAPEUTIC VACCINES
HBV
Auro Vaccines has also developed 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 have been tested in small animals for immunogenicity and down-selection of the lead vaccine candidates has been completed. Further development of this candidate is currently on hold and is available for out-licensing or co-development.
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 Auro Vaccine GeneVax™ prime/VesiculoVax™ boost therapeutic HBV vaccine is designed to be used in conjunction with drug therapy to cure HBV infection.
HCV
Auro Vaccines is developing a GeneVav™ 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. Further development of this candidate is currently on hold and is available for out-licensing or co-development.
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 Auro Vaccine 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
Auro Vaccines 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. Further development of this candidate is currently on hold and is available for out-licensing or co-development.
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.