Svenska Vaccinfabriken (SVF) granted US-patent regarding chimeric genes for immunotherapy against chronic hepatitis B and D virus infections

The 2nd of February 2021, SVF was granted a U.S patent (No: 10,905,760) covering chimeric genes and polypeptides that are useful for the generation, enhancement, or improvement of the immune response to chronic hepatitis B and D virus infections.

Svenska Vaccinfabriken (SVF) , which is part of the investment company Karolinska Development  ‘s portfolio, is a research company that develops therapeutic proteins and genetic vaccines for the treatment of, among other things, hepatitis B and hepatitis D. The development platform is developed by researchers at Karolinska Institutet in Huddinge and the hope is that it will be able to lead to faster development of vaccines against both existing and new diseases.


The various viruses in the hepatitis family primarily attack the liver, which can lead to serious complications such as cirrhosis and liver cancer. The special thing about hepatitis D is that it only spreads in people who are already infected with hepatitis B.

The consequences are largely the same, but the course is much faster. In a person affected by hepatitis B, serious diseases of the liver can occur after about 30 years with the disease. With hepatitis D, it only takes between 5 and 10 years before the course of the disease becomes serious.

WHO estimates that there are upwards of 260 million people worldwide living with chronic hepatitis B, despite the availability of preventive vaccines and antiviral treatments. Each year approximately one million infected people die due to complications resulting from the disease. Of the patients with hepatitis B who are on treatment, more than one in seven are also infected with hepatitis D.

The WHO’s Agenda 2030 program aims to completely eliminate hepatitis. There is a great medical need for hepatitis D, as there is currently no preventive vaccine and, in addition, not many opportunities for treatment.

SVF’s goal is to develop a therapeutic vaccine that, unlike today’s preventive vaccines, has the potential to cure already infected patients. The company uses a proprietary immunotherapy that produces specific antibodies whose task is to block the virus’s ability to penetrate human host cells.

Early preclinical data with the drug candidate SVF-001, show good results where mice with human liver that received antibodies against SVF-001 and then showed 100 percent protection from both hepatitis B and D. If all goes well and funding is in place, SVF hopes that a phase I study can be initiated during the next year.

With SVF-001, the body’s cells are trained to become a vaccine factory, which then activates the immune system and independently produces antibodies that act as inhibitors of the bond between the virus envelope and its receptor on the liver cell. This means that infection is prevented without affecting the cell in any other way. In addition, T cells are activated against both hepatitis B and hepatitis D.

Recently, German MYR Pharmaceuticals released the drug Hepcludex which has a similar function. However, Hepcludex does not help the immune system, but is a peptide-based competitive inhibitor. No immunization takes place and the preparation has also been shown to affect the transport of bile acids due to the binding to the cell’s receptor. Hepcludex also has a short half-life and must therefore be given daily by injection.

In the case of SVF-001, SVF hopes that the treatment will include a maximum of 5 vaccinations, which would make the patient’s life easier when compared to the daily injection required by Hepcludex.

Earlier this year, Karolinska Development  stepped in with an investment and took a five percent ownership stake in Svenska Vaccinfabriken, with an option to increase ownership to 25 percent. Among other things, it is hoped that the investment company’s involvement results in established collaborations with external partners for continued development and commercialization of the products.


From <