Antibody Drug Conjugates (ADCs) formed by monoclonal antibodies with linkers and chemotherapy drug has better tumor targeting effects with less toxic side effects compared to traditionally developed chemotherapy drugs.
As the number of naked antibodies as single agents showing clinical efficacy remains limited, these biological antibodies are playing an essential role in cancer treatment.
The only way to enhance the therapeutic potential of antibodies is to conjugate them to small drug molecules. This combination is targeted to bring together the beneficial effects of highly potent drugs on the one side and selective binders of the specific tumor antigens on the other hand.
Additionally, producing an ADC is more complicated, which needs a thoughtful combination of antibody, linker, and drugs used for targeted and a defined cancer treatment condition.
The design of improved drug compounds that are now in clinical trials is guided by improvement of the ADC technology, and the results gathered from first-generation antibody-drug conjugate (ADC).
Brentuximab vedotin (Adcetris) is an anti-CD30 antibody conjugated to a microtubule inhibitor is the only marketed ADC today available for the treatment of Hodgkin’s lymphoma and anaplastic large cell lymphomas.
Several ADCs are currently undergoing clinical trials that are showing beneficial effects in both hematological malignancies and stable tumor conditions. Among the ADC, T-DM1 (trastuzumab emtansine), which comprised of trastuzumab conjugated to DM1, with a non-cleavable linker, demonstrated promising results in phase III clinical trial used for the treatment of HER2-positive refractory/relapsed metastatic breast cancer.
Other drug compounds, including CMC-544, CDX-011, SAR3419, PSMA-ADC, IMGN901and BT-062 are currently in clinical trials that target different antigens and having different linker and drugs molecules. This will contribute to the learning curve of ADC, as like the discontinued ADC.
In total, 37 active clinical trials involving ADCs are initiated currently, and a significant progression of the pipeline is only observed in Phase 1, and two clinical trials with an almost equal number of studies and only limited studies are in phase 3 trails that will add growth to the market. Recently, two ADCs entered the clinic: Genmab’s MMAE-conjugated HuMax-AXL-ADC that is in Phase 1/2 development used for five different types of solid tumors (ovary, endometrium, cervix, thyroid, and lung).
Along with them, a PBD-conjugated ADC for multiple myeloma (SGN-CD352A), was added to the clinical pipeline. Recently, inotuzumab ozogamicin gained EMA approval for the treatment of relapsed/refractory b-cell precursor acute lymphocytic leukemia.
The high cost of production, lack of experienced manufacturers and regulatory challenges are slowing down the growth of the Global ADCs Market.
The linking of drug compounds to a careful selection of the targets, a better insight on ADCs mechanism of action, the controlling and knowing of ADC off-target toxicities, and also the variety of required clinical settings like patient selection, dosing regimen of the molecules that bring highest clinical benefit are the current challenges that will add to the improvement of the drug therapeutic index.
The primary drivers for the global antibody-drug conjugates market include increasing incidences of cancer types, advances in drug linking technologies, efforts regarding patent protection and growing demand to the antibody drug conjugates.
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