Innovations in antibody-drug conjugates and bispecific antibodies – what you need to know
Bispecific antibodies (bsAbs) and antibody-drug conjugates (ADCs) are currently big business. Both approaches meet the demand for targeted, patient-friendly cancer therapies and are generating a stream of blockbuster products. Big pharma is moving in, snapping up companies or licensing their technology and generating billion-dollar deals, showing that bsAbs and ADCs are increasingly recognised as key therapeutic technologies.
The increasing sophistication of the design process has overcome many early challenges, and products are now obtaining regulatory approval with increasing success. Between the start of 2020 and the end of 2024, the number of approved ADCs increased from 6 to 151, while the number of approved bsAbs leapt from just 3 to 192. And there is much more to come: as of December 2024, there were 30 additional ADCs and 25 multispecific antibodies (20 bispecific, 3 biparatopic, 2 trispecific) in late stage clinical trials3. We can therefore expect many more
of these drugs to come to market in the near future.
Additionally, the worlds of ADCs and bispecifics are moving closer together, thanks to the development of ADCs that bind to two different targets or epitopes (bsADCs). Three products in late-stage clinical trials fall under both headings: two biparatopic HER-2 ADCs and one bispecific EGFR/ HER3 ADC. Bringing these two fields together offers the potential for drugs with even more power and precision.
In this report, our team delves into the different aspects of ADC and bsAb innovation. We also carried out proprietary research into global patent filing data to identify trends in the bsAb and ADC intellectual property space.
In a guest feature, Patrick van Berkel, Chief Scientific Officer of biotech SME, ADC Therapeutics, gives his thoughts on the trends and why there is such current excitement around the ADC modality.
Finally, we explore the growing role of machine learning in antibody design, as well as some of the associated challenges, and consider how patents relating to machine learning may be used by ADC and bispecific companies as part of a wider commercial strategy, which we expect to be of benefit to our current and future clients.
[1] by at least one regulatory authority worldwide
[2] The Antibody Society. Therapeutic monoclonal antibodies approved or in regulatory review. (10 January 2025); www.antibodysociety.org/antibody-therapeutics-product-data. Biosimilar antibodies are not counted,
[3] The Antibody Society. The Antibody Society. Antibody therapeutics in late-stage clinical studies. (10 January 2025); www.antibodysociety.org/antibodies-in-late-stage-clinical-studies/. Late-stage clinical trials refers to pivotal Phase 2, Phase 2/3 or Phase 3. Biosimilar antibodies are not counted. Drugs that are both ADCs and multispecific antibodies are double-counted; i.e., the same drug is counted as both as an ADC and as a multispecific antibody.
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