Antiviral Agent (Burfiralimab)

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. ImmuneMed have discovered burfiralimab that can overcome the shortcomings of existing antiviral agents, and we are developing it as an antiviral and anti-inflammatory 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 cannot 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. Most of us experienced the disease progresses due to excessive inflammation such as a cytokine storm in the COVID-19 pandemic, ImmuneMed expect to be able to pioneer a new antiviral drug market with the commercialization of burfiralimab, which will overcome the shortcomings of existing antiviral drugs.

What is burfiralimab?

Burfiralimab is a humanized monoclonal antibody found in virus-infected animals and has shown excellent effects in various viral and inflammatory diseases in animal models. Burfiralimab is activated by binding to target proteins that appear on the cell surface specifically for cell damage such as viral infection. In a number of GLP non-clinical toxicity studies, there were no serious adverse events caused by burfiralimab administration. In phase 1 clinical trials involving healthy subjects in Korea and Australia, there were no serious adverse events caused by drug administration, and safety and tolerability were confirmed. Phase 2 clinical trial was conducted on moderate and severe COVID-19 patients in overseas, identifying its potential as a treatment for severe cases. In addition, starting with the phase 2 clinical trial for chronic hepatitis B, we will conduct phase 2 clinical trials for rheumatoid arthritis and continue to expand the indications.

Burfiralimab Features and Benefits

Virus suppression action applicable to various viruses
Low side effects and excellent tolerability as an antibody-based bio-derived material
Acts specifically on virus-infected cells
Anti-inflammatory ability to inhibit the infiltration of immune cells
Expected long half-life in the body

Burfiralimab

Completion of cell line development (MCB)
Production of drug substance/drug product (Lonza, GMP)
Toxicity (GLP) test (single dose, 4 weeks & 26 weeks repeated doses, reproductive and developmental toxicity)
Antibody characteristics (no ADCC & CDC activity, high FcRn affinity)
Long half-life (3 weeks)
low immunogenicity
Completion of clinical phase 1 (single, repeated, intravenous administration, intramuscular administration)
Indications: chronic hepatitis B, COVID-19, influenza, rheumatoid arthritis, etc.
Completion of COVID-19 phase 2 clinical trial
Chronic B hepatitis clinical phase 2a ongoing
Securing non-clinical data for influenza and rheumatoid arthritis

Burfiralimab

HBV Strategy

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

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

Future Plan

01. Non-clinical trial
- Rheumatoid arthritis efficacy test
- Reproductive and developmental toxicity study (Seg III)
- Carcinogenicity study
02. Clinical Trial
- Phase 2 clinical trial
  1. 1. Chronic hepatitis B
    (Korea) in progress
  2. 2. Rheumatoid Arthritis:
    Preparing overseas
03. Expansion of Indications
- Rheumatoid arthritis
- Scleroderma, IPF
04. Pipelines Secured
- Introduction and
  development of new
  Platform Tech
- S and C projects
- Anticancer
- cGvHD