Bispecific Antibody Application in Gene Therapy

Background of Gene Therapy

Gene therapy is a therapeutic strategy that has been wielded in a variety of diseases. It generally involves transferring genes via a vector into target cells, followed by gene addition, correction, or suppression, to provide or repair a missing or defective gene related to diseases. There are 3 facets of gene therapy:

• Gene silencing using siRNA, miRNA, and shRNA;
• Gene replacement via plasmids and viral vectors;
• Gene editing-based therapy using specific nucleases to modify the mutations.

The goal of gene therapy is to ensure the specificity of gene delivery to target cells and tissues and stable expression of therapeutic genes, and meanwhile, not disrupt the functional integrity of the cells. Therefore, gene therapy drugs are comprised of a therapeutic gene determining the specific therapeutic action, and a gene transfer vector, which contributes to the stability of delivery and expression of therapeutic genes.

Applications and Advantages of BsAbs in Gene Therapy

Bispecific antibodies (BsAbs) can be associated with gene therapy in two ways.

• BsAbs as available tools to direct gene transfer vectors to target cells

With the flexibility in design and ability to simultaneously bind to both viral surface protein and molecules on the cell surface, BsAbs can act as adapter molecules to link the vector to a specific marker expressed on the target cell. Using BsAbs as adapters does not require modifications to the virus structure, thus avoiding possible damage to vector assembly, activity, and stability. Another remarkable advantage is that once an adapter for a particular vector has been proven effective, any other therapeutic gene can be delivered by the corresponding derivative of this vector.

• BsAbs as therapeutic genes

On the other hand, BsAbs can be delivered to patients as therapeutic genes by gene therapy. Compared to being injected as proteins, local expression of BsAbs by gene therapy might contribute to achieving continuous and/or effective antibody concentration and/or better antibody biodistribution, and overcoming antibody clearance or difficulties in accessing tumors.

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