Antiviral Agent (VSF)

Antivirals

Various synthetic drugs and human-derived interferon are currently used as antiviral drugs, but they have many limitations in clinical practice. Synthetic drugs have a problem of increasing tolerability when used continuously, and interferon is used for various types of viruses, but its effectiveness is quite limited, and several side effects have been reported. We have discovered VSF (Virus Suppressing Factor) that can overcome the shortcomings of existing antiviral agents, and we are developing it as an antiviral agent.

Antiviral Drug

The current antiviral market is about 30 trillion KRW (30 billion USD). A significant portion of viral diseases are intractable diseases, and the growth potential of the antiviral market in the future is very high. Chemical agents can not be used in the long term due to increased tolerability and side effects, and interferon has a low efficacy, so its proportion in the market has rapidly decreased. It is expected that the commercialization of VSF, which will overcome the shortcomings of existing antiviral drugs, will be able to discover a new antiviral drug market.

What is VSF?

VSF is an in vivo product like Interferon and has shown a superior effect against various viruses incomparable to Interferon in animal studies. VSF exhibits antiviral activity by binding to target proteins that appear specifically on the cell surface of virus-infected cells. There was no serious adverse event caused by the hzVSF administration in the GLP non-clinical toxicity study. In the phase 1 clinical trial targeting healthy people in Korea, there were no serious adverse reactions due to drug administration, and safety and tolerability were confirmed. A phase 2 clinical trial had been conducted overseas for COVID-19 patients, and a phase 2 clinical trial is underway for COVID-19 patients in Korea. And we aim to confirm the safety and the efficacy of hzVSF in the phase 3 clinical trial. In addition, we plan to conduct clinical trials for various indications, starting with the Phase 2 clinical trial for chronic hepatitis B.

VSF Features and Benefits

Strong antiviral activity
Antibody-based material with low side effects and good tolerability
Antiviral effects for various viruses by acting on the innate immune mechanism
Acts specifically on virus-infected cells
Anti-inflammatory ability to inhibit the infiltration of immune cells
Expected to have a long half-life in the body

hzVSF

Cell line development (MCB, WCB)
Production of drug substance and drug product (Lonza, GMP)
Toxicity test (single 4 weeks, repeat 26 weeks)
Antibody characteristics (no ADCC & CDC activity, high FcRn affinity)
Long half-life (3 weeks)
Low immunogenicity
Indications: chronic hepatitis B, Covid-19, influenza, etc.

hzVSF

HBV Strategy

Cure
Increase functional cure(~50%)
→ complete cure
Antivirals
(NAs)
Complete cure (X)
→ Functional cure (< 4%)
Immunotherapy
(VSF)

Modified form Revill & Zoulim, Nature Reviews Castro & Hepatol 2016: Zoulim, EASL ILC 2016

Future Plan

01. Non-clinical trial
- Efficacy test in Woodchuck
  model
- 26 weeks long-term toxicity
  test
02. Clinical Trial
- Phase 1 clinical trial
  1. Completed Korea phase 1
  2. In progress of Australia
    phase 1
- Phase 2 clinical trial
  1. Chronic hepatitis B : Korea
    in progress
  2. COVID-19 : Europe, Asia,
    Korea in progress
03. Expansion of Indications
- Covid-19
- Fatty liver (Steatosis, NASH)
- GVHD, Scleroderma, IPF
04. New Pipelines
- Development of
  new Platform Tech
- Cancer
- Aging