FB704A

FB704A

Indication
Autoimmune diseases, i.e. rheumatoid arthritis, systemic sclerosis, severe neutrophilic asthma
Mechanism of Action
FB704A is a fully human monoclonal antibody that inhibits IL-6/IL-6R signaling pathway by neutralizing IL-6. IL-6 pathway has emerged as a pivotal pathway involved in immune regulation in many cancers and immune disorders.
CURRENT STATUS
1.Completion of phase 1 study in US.
Phase 2 severe neutrophilic asthma recruiting in Taiwan.
Efficacy
  • FB704A fully human monoclonal antibody new drug, targeting human interleukin 6 (IL-6), neutralizes IL-6 and inhibits IL-6/IL-6R signal transmission, which has been shown in many clinical trials. More than half of patients who do not respond to TNF-α antagonists have excellent efficacy in the treatment of IL-6/IL-6R antagonists, which greatly increases the market value of FB704A in drug development.
  • The current experimental results show that FB704A can effectively inhibit the secretion of the inflammatory chemokine MCP-1 and VEGF from synovial membrane cells in patients with rheumatoid arthritis, verifying that FB704A has the potential to treat rheumatoid arthritis. In addition, FB704A has also completed a series of safety tests such as cell binding analysis, cytokine release, hemolysis test, etc., confirming its excellent safety. The 6-week repeated dose toxicology experiment conducted in rhesus monkeys pointed out that there were no drug-related adverse reactions.
  • In terms of indications, blocking the IL-6/IL-6R response is related to the treatment of many diseases. There are also relevant clinical trials in progress in systemic inflammatory diseases, cytokine storm and severe neutrophilic asthma, so that FB704A has more potential market. Overall, FB704A has core competitive advantages such as good safety, strong drug efficacy, and a wide range of treatment groups and indications.
  • The company uses self-built key technology and self-developed new drug platform to complete the complete development of FB704A from screening to preclinical bioactivity confirmation, including: screening of the whole human antibody library, affinity optimization, in vitro pharmacological activity confirmation, Indication exploration and confirmation, high-yield cell line screening, upstream 5L PD process optimization, downstream purification platform construction, and establishment and validation of antibody physical and chemical analysis and functional analysis methods.
  • FB704A has completed GMP scale production and pre-clinical toxicology study, and obtained the US FDA IND permission for Phase I study in February 2018. The patient recruitment of Phase I study in the US has completed in May 2020.
  • FB704A (anti-IL6 mAb) may also improve symptoms of neutrophilic and mixed granulocytic severe asthma by inhibition of classic and trans-signaling pathways of IL-6. Among the patients with these two subtypes of severe asthma, it is likely that FB704A may reduce Th1, Th2 and Th17 inflammation as well as airway hyper-responsiveness. The current recruiting severe asthma trial is for treatment in patients with severe asthma who have higher neutrophil counts in sputum. Such subtype of severe asthma can’t be well controlled by current treatments and FB704A will explore the possibility of improving symptoms on these severe asthma patients.
  • The global population affected by neutrophilic asthma is about 110 million people1. Severe asthma accounts for 5% of total asthma patients2, so it is estimated that there will be 5.5 million severe neutrophilic asthma patients. Sever neutrophilic asthma is a refractory disease that causes huge medical expenditure and cannot be effectively controlled by drugs currently on the market. There remains no effective biologics approved for treating severe neutrophilic asthma, either. The role for IL-6 in the pathology of this disease shows that FB704A has the potential to fulfil the unmet medical need in severe neutrophilic asthma. The global biologics market for treatment in severe neutrophilic asthma is estimated to reach US$90 billion by multiplying patient number and the average annual cost of biologics treatment at US$16,4253.


Ref:

1. Source: Literature Review, Frost & Sullivan Analysis

2. European Respiratory Journal 2018 52: PA3918

3. The Potential American Market for Generic Biological Treatments and the Associated Cost Savings

http://www.sonecon.com/docs/studies/0208_GenericBiologicsStudy.pdf