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KDDF-201406-08 Development of newly defined antiviral drug that selectively acts on the virus infected cells(Infectious Diseases, Protein) [10.01.2014]

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Development and Market Objectives

Virus Suppressing Factor (VSF) is an antiviral protein that inhibits various pathological activities essential to viral replication. It specifically targets on receptor of virus infected cells and have been classified as an investigational new drug following lead candidate nomination and preclinical trials through the optimization of humanized VSF (HzVSF), providing a new concept for the treatment of viral diseases. 

Unmet Medical Need & Target Patients

Target patients
- This candidate is under development for the treatment of hepatitis B and C. Infected patients with clinical symptoms caused by immunophathologic phenomena, such as inflammation arising from viral infection will be prioritized.
- Initial target indication
Hepatitis C: There are an estimated 170 million international patients (with more than 350 thousand people dying from the disease each year), and more than 600 thousand domestic patients
- Secondary target indication
Hepatitis B: There are an estimated 400 million international patients (with more than 1 million people dying from the disease each year), and more than 2 million domestic patients
 - Tertiary target indication
Other serious viral diseases that cause clinical symptoms arising from inflammation by virus infection

Unmet medical needs
- The existing antiviral therapies are only effective for specified viral strains
- There is a strong unmet need for new therapies that can reduce the excessive immune reaction, such as inflammation caused by viral infection
- Novel treatments with a wide range of anti-viral and anti-inflammatory activity are needed for the treatment of patients who do not receive therapeutic benefit from existing drugs.
- A new drug that can synergize with existing treatment options for combination therapy is needed.

Status

Epibase in vitro immunogenicity screening was performed for deduction of the candidate which was less active as immunogen in clinical usage. Efficacy test for HCV and HBV was carried out in vitro. The anti-viral efficacy against HCV genotype 1a, 1b and 2a of the candidate was tested and was similar with sofosbuvir (SOVALDI?) which is currently used for the treatment of HCV. In addition, the candidate inhibited HBV cccDNA replication. And currently, the candidate is validating for efficacy against HCV and HBV using SCID/Alb-uPA mouse model which is engrafted with human liver. The candidate is also evaluating with the Woodchuck model using Woodchuck hepatitis virus (WHV) which shows the similar clinical symptoms with HBV-infected patients.
To validate the efficacy of the candidate for Ebola, the experiment is performing the in vitro and in vivo (guinea pig and HNP) at Biosafety Level 4 (BSL4) facility in University of Texas Medical Branch at Galveston, US.

Intellectual Property

Patent Name: Novel anti-viral VSF protein and hybridoma producing same
-2 registration patents, 1 public PCT
-Registration Countries: Korea, USA
-Patent Registration Number / Registration Date
United States of America, 7,514,082 / 2009.04.07.
Republic of Korea, 0425030 / 2004.03.17.
PCT, WO 2003064461 A1 / 2003.01.30.


- Patent Name: An antibody specifically binding to separated peptide derived from XXXX, or a fragment thereof binding to the peptide
2 patent application
Applied Countries: Republic of Korea, PCT
Patent Registration Number/ Registration Data
Republic of Korea, 10-2015-0082132/ 2015.06.10
PCT, PCT/KR2015/005917/2015.06.12
 

Competitive Advantages

- In contrast to existing treatment options, we are developing a first–in-class humanized antibody that exhibits dual properties of antiviral and anti-inflammatory effects, which can selectively act on virus infected cells.
- There is a high likelihood for success, because the drug is phenotype-based, rather than target-based therapeutic.

- There are many opportunities of indication expansion in various acute and chronic viral diseases. 
- It is expected to have synergy with both anti-viral and anti-inflammatory effects when used in combination with currently available antiviral therapies.

Indication

Infectious Disease

Research Period

2014.9.1-2017.2.28

Company

ImmuneMed Inc.

Developmental Stage

Optimization

Additional Information

Contact Information

Contact
Address Company Name: ImmuneMed Inc.
WebSite Homepage: http://www.immunemed.co.kr Contact Person: Yoon Won Kim
E-mail: ywkim@immunemed.co.kr Contact: +82-33-248-2633

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