Inovio Pharmaceuticals (NYSE MKT: INO) says that its synthetic and therapeutic hepatitis B vaccine generated strong T cell responses that eliminated targeted liver cells in mice, pointing to the vaccine's potential to clear the infection and prevent liver cancer.
The DNA vaccine maker said Monday the development is encouraging given that nearly one third of the world's population is infected with hepatitis B, with 400 million at risk of developing liver cancer.
Shares in the company surged more than 20 per cent pre-market, to 65 cents on Monday morning.
Results from the company's preclinical study were published in the peer reviewed journal, Cancer Gene Therapy.
In the study, a DNA vaccine encoding a hepatitis B core antigen using Inovio's SynCon vaccine technology was administered, also using the company's electroporation-based delivery technology.
Inovio said researchers saw that the vaccine induced strong "killer" T cells in mice, and those killer T cells, while found systemically, were also present in the liver. This cleared the hepatitis B antigen-expressing liver cells, without inducing liver damage, the company added.
The vaccine maker is also investigating additional hepatitis B antigens to develop a "multi-component vaccine" that can provide the host immune systems multiple targets to clear the hepatitis B virus and infected liver cells.
"Inovio has established a potent immune therapeutics platform," said president and CEO, Dr. J. Joseph Kim.
"With our recent scientific breakthrough represented by our human data showing the powerful killing effect of T cells generated by our cervical dysplasia therapeutic vaccine, we are encouraged by the published preclinical results generated by our therapeutic vaccine against HBV.
"Hepatitis B is one of the most important global health problems, and we are excited by the prospect of addressing HBV and other chronic infectious diseases with our vaccines.
Inovio's SynCon vaccines are designed to provide two capabilities not achievable with conventional vaccines: stimulation of T-cell immune responses to provide therapeutic capabilities, and universal cross-strain protection and treatment against known as well as newly emergent unmatched strains of pathogens. The company has clinical programs for cervical dysplasia, leukemia, the hep C virus, the flu and HIV.
During the third quarter, the company reported that its SynCon vaccine against cervical cancer, known as VGX-3100, achieved an "industry first" when T-cell immune responses induced by this vaccine were shown to generate a strong killing effect against cells changed by HPV into precancerous cervical dysplasias.
In the hepatitis B vaccine study, the antigen for which the the DNA vaccine was encoded for represented a "consensus of the unique HBcAg DNA sequences of all major hepatitis B genotypes", Inovio said.
"Taken together, this is the first study to provide evidence that intramuscular immunization can induce killer T cells that can migrate to the liver and eliminate target cells."
The company noted that although an effective preventive vaccine against hepatitis B has existed for over three decades, it remains a major epidemic, especially among the people of Asian and African descent.
Currently, the only therapies available for chronically infected individuals are interferon-a and nucleoside analog treatments, which function by controlling viral replication but do not clear infection. Interferon can prevent viral replication in only 30 per cent of patients and does so with undesirable side effects, Inovio said.
One of the major causes for liver cancer is infection by hepatitis B, with the cancer being the third most common cancer and the most deadly.
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