Humanized Anti-ST2 Antibody BSI-056T used for the treatment of asthma

Partnering objectives
Seeking a collaborative licensing opportunity with a company that has a strategic interest in the treatment of asthma, atopic dermatitis and chronic obstructive pulmonary disease.

Field: Treatment of asthma, atopic dermatitis and chronic obstructive pulmonary disease.

Technology and MOA
MOA:ST2 antagonist, a humanized anti-ST2 antibody inhibits binding of IL-33 to the ST2.

IL-33 and ST2 play important roles in allergic bronchial asthma. IL-33 contribute to the induction and maintenance of eosinophilic inflammation in the airways by acting on lung fibroblasts by binding to its ST2 receptor. ST2 is a member of the interleukin-1 receptor family and exists in a transmembrane (ST2L) and a soluble form (sST2) due to alternative splicing. Unregulated IL-33 activity leads to activation of T-helper type 2 cells, mast cells, dendritic cells, eosinophils and basophils, ultimately leading to increased expression of cytokines and chemokines.  The drug candidate BSI-056T targets the ST2 and inhibits its binding to the IL33 thereby alleviates the condition.

Marketing opportunity
The binding of IL-33 to the ST2 receptor activates inflammatory cells through the nuclear factor-κB and mitogen-activated protein kinases pathways and induces the expression of Th2-type cytokines.

Excessive stimulation of ST2/IL-33 was associated with autoimmune diseases, including arthritis, allergic inflammation, and airway hyperactivity, pointing to a significant function of ST2 in the pathogenesis of inflammation-related diseases. And studies have shown that blockage of IL-33 signaling by a soluble ST2 protein or anti-ST2 mAb inhibits the immune response of asthma in mice.

The global market for asthma should reach $21.1 bn in 2025.
RG-6149’s net present value is estimated about 100 million USD by GlobalData

Differentiable treatment with potential to be first/ best in class
BSI-056T demonstrates a higher affinity and better in vitro bioactivity than RG-6149 (AMG-282, Amgen Inc.), which is currently in phase-II clinical trial

Indications
• Asthma
• Atopic Dermatitis
• Allergic inflammation
• Airway hyperactivity

Data
Key parameters of humanized anti-ST2 antibody BSI-056T as compared to RG-6149:
• Exhibits comparable affinity as compared to RG-6149
• Shows more potent in vitro efficacy
• Shows overlapped epitope to RG-6149
• In vivo efficacy and PK/PD studies on-going
• Cell-line development and CMC are on-going and is expected to file IND in Q3 of 2021

Intellectual property
For discussion under CDA.