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ADC Linker and Conjugation Technologies have emerged as a
versatile solution for the development of more efficient and stable antibody
drug conjugates.
The global ADC
technology market size is estimated to grow from USD 1.18 billion in 2023
to USD 4.37 billion by 2035, representing a CAGR of 11.5% during the forecast
period 2023-2035.
Conventional anti-cancer therapeutics are characterized by
on-target-off-tumour toxicities, making such therapies detrimental to patients.
This limitation led to the development of more efficacious and targeted therapy
such as antibody drug conjugates (ADCs). ADCs are a complex and versatile form
of anti-cancer therapy, which have been proven to be more effective and less
toxic to patients.
Such interventions are designed to identify specific
antigens that are expressed on the surface of target (cancer) cells so that the
effects of the cytotoxin / drug are focused on the elimination of only the
tumour cells. Owing to the target
specificity component, the approach reduces the chances of damaging normal
cells. Over the years, this class of therapeutics has undergone several
improvements, most of which were focused on how the highly potent cytotoxic
component could be attached to the segment that confers specificity (the
antibody). The physical attachment of the aforementioned components is
facilitated in a process that is commonly referred to as conjugation, or
bioconjugation. This chapter features brief descriptions of the different types
of linker and conjugation technologies that are used in the development of
ADCs. Further, it offers insights from the industry’s perspective, concerning
the future of these technologies.
Antibody Drug Conjugates
Antibody drug conjugates (ADCs) are an upcoming class of
targeted therapeutic agents. Fundamentally, these complex biotherapeutic
entities demonstrate the combination of target specificity of an antibody and
therapeutic features of a chemotherapy / cytotoxic drug.
Components of ADCs
The failure of first-generation ADCs has been attributed to
the use of unstable acid-labile linkers, which are prone to degradation in
acidic environment of the cell. Since then, linker technologies have undergone
significant advances and improvements. Early linkers, which were derived from
the acid cleavable hydrazones, could be cleaved at non target sites and
thereby, were known to cause systemic toxicity. To overcome these challenges,
second-generation linkers, with improved stability, were developed. Further,
third-generation conjugation technologies were developed to generate
site-specific ADCs without any engineering / modification of the conjugation
site.
It is evident that the evolutionary advances in conjugation
and linker technologies have enabled the development of viable treatment
options. Such improvements have significantly altered the therapeutic potential
and likely applications of ADCs. In other words, succeeding generations of
conjugated drugs, based on improved technologies are more selective in
targeting diseased cells and have broader therapeutic windows.
Despite the current opinion on the superiority of this class
of therapeutics, the existing understanding of the biochemical, immunological,
pharmacological, and molecular aspects of ADCs needs to be furthered in order
to design and develop better versions of these products. The choice of a
suitable target antigen and cytotoxic payload is important, however, the
conjugation approach used and linker chemistry involved are equally crucial
elements for manufacturing viable leads. In fact, linker instability and
product heterogeneity (variations in DAR between conjugate molecules
manufactured in a singular batch) are known to severely compromise ADC efficacy
and therapeutic window, which may cause difficulties in the lead optimization
for clinical application, eventually resulting in trial failure. As a result,
there are a number of efforts directed towards the development of better / more
stable linkers and site-specific conjugation methods that enable manufacturers
to synthesize homogeneous batches of ADCs. The demand for ADCs is on the rise.
In this context, it is important to mention that ADCs have also been proven to
be more effective in treating bacterial infections than conventional
antibiotic-based treatment regimens.
Another popular field that has emerged as
a potential application area for ADCs, is chronic clinical conditions. In this
case, selective payload delivery, using ADCs, to disease-associated biological
targets has been demonstrated to reduce side-effects. In terms of novel
treatment paradigms, ADCs are also being investigated in combination with
small-molecule drugs. The growing popularity of this approach can be attributed
to its potential to overcome the concerns related to multi-drug resistance.
With the growing demand for ADCs, therapy developers, as indicated earlier, are
striving to discover and develop better conjugation methods and the means to
further tap into the vast potential of these therapeutics.
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