Therapeutic bispecific antibody formats: a patent applications review (1994-2017)

ABSTRACT

Introduction: Bispecific antibodies have become increasingly of interest by enabling new therapeutic applications such as retargeting cellular immunity towards tumor cells. About 23 bispecific antibody platforms have therefore been developed, generating about 62 molecules which are currently being evaluated for potential treatment of a variety of indications, such as cancer and inflammatory diseases, among which three molecules were approved. This class of drugs will represent a multi-million-dollar market over the coming years. Many companies have consequently invested in the development of bispecific antibody platforms, creating an important patent activity in this field.

Areas covered: The present review gives an overview of the patent literature over the period 1994–2017 of different immunoglobulin gamma-based bispecific antibody platforms and the molecules approved or in clinical trials.

Expert opinion: Bispecific antibodies are progressively accepted as potentially superior therapeutic molecules in a broad range of diseases. This frantic activity creates a maze of hundreds of patents that pose considerable legal risks for both newcomers and established companies. It can consecutively be anticipated that the number of patent conflicts will increase. Nevertheless, it can be expected that patents related to the use of a bispecific antibody will have tremendous commercial value.

KEYWORDS:

• Bispecific antibody
• BiTE
• cancer
• CrossMAb
• immunoglobulin gamma
• inflammatory disease
• Knobs-into-Holes
• nanobody
• Triomab quadroma

Article highlights

• This review gives a comprehensive overview of the patent literature over the period 1997-2017 of different immunoglobulin gamma-based bispecific antibody platforms and the molecules approved or in clinical trials.

• Immunoglobulin gamma-based bispecific antibodies are increasingly accepted as potentially superior therapeutic molecules in a broad range of diseases.

• About 23 bispecific antibody platforms have generated about 62 molecules that are currently being evaluated for potential treatment of a variety of indications, such as cancer and inflammatory diseases, among which three molecules have been approved.

• The quick advancements of bispecific antibody technologies require a steady adaptation of patent strategies, to ensure that future products will still be protected by intellectual property rights.

• This frantic activity creates a maze of hundreds of patents that pose considerable legal risks for both newcomers and established companies.

This box summarizes key points contained in the article.

Declaration of interest

The authors are employed by Argenx BVBA. The authors have no other relevant affiliations or financial involvement with any organization or entity with a financial interest in or financial conflict with the subject matter or materials discussed in the manuscript apart from those disclosed. Peer reviewers on this manuscript have no relevant financial or other relationships to disclose.

Additional information

Funding

This work was supported by the Agentschap voor Innovatie door Wetenschap en Technologie (IWT, grant #IWT130849).