Antiviral Agent (VSF) | ImmuneMed

Antiviral Agent (VSF)

Antivirals

Currently used viral therapies include a variety of synthetic drugs and human-derived Interferon, but they all have a number of limitations in clinical practice. Synthetic drugs have a problem of increased tolerance when used continuously. Interferon has been used for many types of viruses, but its effects are quite limited and several side effects have been reported. We have discovered an original material (VSF: Virus Suppressing Factor) and registered its patent at home and abroad.

Antiviral Drug

The current antiviral market is about 30 trillion KRW. The majority of refractory diseases are viral diseases so the growth potential of the antiviral market is very high. For example, chemicals are only used locally for increased resistance and side effects. Interferon formed a market worth of 11 trillion KRW in the early stage of market entry, but its market has been reduced to about 700 billion KRW due to low drug efficacy. New antiviral drug development in the future will create a new market, which is expected to expand to more than 30 trillion KRW.

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. The phase I clinical studies are currently in progress in Korea, and no serious adverse events caused by drug administration have been reported. We will conduct clinical studies for various indications starting with phase II clinical studies on HBV.

VSF Features and Benefits

  • Strong virus inhibitory effect in vivo and in vitro
  • Low side effects and tolerance through the use and development of secretory substances in vitro
  • Inhibitory effect on various viruses with the use of innate immunity and action on cells
  • Response and action specific to virus-infected cells
  • Anti-inflammatory ability to inhibit infiltration of immune cells
  • Long half-life in vivo due to humanized IgG4

hzVSF

  • Cell Line Development (MCB, WCB)
  • Drug Substance (Lonza, GMP)
  • Drug Product (Baccinex SA, GMP)
  • Toxicity Study (SAD 4 weeks, MAD 13 weeks, GLP)
  • Biological Activities (no ADCC & CDC activity, high FcRn affinity)
  • Long Shelf-Life (3 weeks)
  • Low Immunogenicity
  • Indication : Chronic Hepatitis B, Influenza, etc.

hzVSF

  • hzVSF image
  • hzVSF image

HBV Strategy

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

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

Future Plan

  • 01. Nonclinical Trials

    • Validity in Woodchuck Model and
      Toxicity Study
      1. Dosing in progress alone and in combination
        (Georgetown Univ., Dr.Menne)
    • Long term GLP Tox Test
  • 02. Clinical Trials

      1. 2020' 1Q Expected
      2. SAD, MAD, Vein, Muscle administration
    • Clinical trials Ph2 in Korea:
      Chronic Hepatitis B
      1. 2020' 2Q Expected
      2. Clinical trials Ph2: 2020' 3Q Expected
  • 03. Indication Extension

    • MERS-CoV
    • Fatty liver(Steatosis, NASH)
    • Immune / Inflammatory Diseases
      1. GVHD, Scleroderma, IPF
  • 04. Secure Pipeline

    • Introduce and develop new Platform Tech
    • Cancer
    • Aging