Bispecific antibodies (bsAbs) and multispecific antibodies (msAbs) are a growing class of biotherapeutics that come with many engineering and development challenges. WuXi Biologics established the WuXiBody and SDArBody technology platforms to overcome these challenges and meet the needs of biologics developers pursuing different biology and therapeutic approaches via these novel modalities. WuXiBody TM A proprietary, highly flexible engineering platform that greatly enhances the developability characteristics of bsAbs. SDArBody TM A unique platform utilizing single domain antibodies (VHH) as building blocks to further facilitate the exploration of more complex biologics such as msAbs.
Overcoming Technical Challenges of BsAbs and MsAbs Platforms
WuXiBody TM BsAb Technology Platform
The technical challenges of developing bsAb and msAb include: (A) the engineering challenges to solve chain mispairing issues; (B) Developability issues that impact manufacturing efficiencies and costs or clinical efficacy and safety Primary Technical Challenges
The WuXiBody platform is an innovative, proprietary technology platform developed for the expanding use of bispecific antibodies as therapeutics. Based on novel engineering, the platform expedites the drug development process by 6-18 months and significantly reduces production costs. This platform takes almost any monoclonal antibody (mAb) sequence pair and assembles it into a bispecific construct. The platforms unique structural flexibility allows for efficient construction of various formats with different valency (e.g., 2, 3 or 4 binding sites).
(A)
(B)
E icacy
Safety
Examples of formats enabled by WuXiBody
Side Products (chain mispairing)
VH
VH
VL
VL
Clinical Candidate
Immunogenicity
PK/PD
CH1
CL
TCR Cꞵ
TCR Cɑ
Physio Chemical Properties
A
A
A
A
A
A
B
B
B
Manufacturability
B
B
A
A
B
B
B
A
B
B
B
A
B
B
B
1+2
2+2
1+1
1+2
2+2
1+1
1+2
2+2
WuXiBody and SDArBody platforms were developed to overcome these challenges.
The WuXiBody platform enables our partners to take any two monoclonal antibodies (mAbs) and engineers these into a highly-functional bsAb and to bring those novel bsAbs into the clinic significantly faster and with titers and yields rivaling regular mAbs.
Target Biology
Ab Engineering
Development
Flexibility: 1+1, 1+2 or 2+2 binding sites Pharmacokinetics: long in vivo half-life
Universality: Compatible with most mAb pairs
Strong Developability: High titer, yield, solubility and serum stability
X months
2-4 months
16-18 months
WuXiBody TM
Targets
mAbs
IND-ready
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