This therapy combines innovations from biotechnology and chemistry to form a new class of highly potent drugs of biopharmaceutical. The details of some antibody drug conjugates are described as follows.

Gemtuzumab ozogamicin: It is a recombinant, humanized IgG4 monoclonal antibody (mAb), which act by targeting CD33, an antigen expressed on most leukemic blast cells but also on normal hematopoietic cells. The antibody is linked to calicheamycin and was the first ADC approved in 2000 by the FDA, for use in patients with relapsed acute myelogenous leukemia. Almost from the outset however, the use of this drug was associated with significant side effects.

Brentuximab vedotin: This ADC consists of a chimeric antibody directed to CD30, a member of tumor necrosis factor receptor family. CD30 is expressed rarely on T or B cell lymphomas, but is a tumor marker for typical embryonal carcinomas, Hodgkin's Lymphoma and anaplastic large cell lymphoma. The conjugation of antibody takes place with the antimitotic compound monomethyl auristatin E. This drug was granted marketing approval in August 2011 and is the first new Hodgkin’s Lymphoma drug in 30 years. Several other ADCs are currently in clinical trials for FDA approval.

Trastuzumab emtansine: This conjugate is based on the well studied antibody Trastuzumab which acts by targeting HER2 cell surface protein and which was approved in 1998 for use in patients with HER2 positive metastatic breast cancer. The widespread clinical experience with this antibody has aided in both selection of an appropriate drug (maytansine derivative DM1) and the conjugation chemistry.

Inotuzumab ozogamicin: The conjugate contains an IgG4 monoclonal antibody targeting the CD22 antigen found on mature B cells. It was shown to be more effective in vitro in killing primary pediatric acute lymphoblastic leukemia cells. In spite of the high potency of the drug moiety, preliminary clinical studies proposed relatively low tolerable doses of this drug. It is currently in the ongoing clinical trials, which includes two combination trials studies of Phase III with the drug Rituxin.

Lorvotuzumab mertansine: This is a humanized monoclonal antibody which acts by targeting CD56, an isoform of neural cell adhesion molecule expressed on NK cells, some T cells and on the majority of Small Cell Lung Carcinoma and Multiple Myeloma cells. Different chemistry has been used to prepare this ADC. The antibody is coupled to mytansioid (DM1) through a linker cleavable by disulfide reduction. It was granted orphan drug status in 2010, both in the USA and Europe for Mantle Cell Carcinoma, and at present also under clinical investigation for Ovarian Cancer, Multiple Myeloma and Small Cell Lung Cancer.

Our Company has more than a decade of experience in Antibody Drug Conjugate (ADC) technology, which allows monoclonal antibodies to treat the targeted diseased area more effectively. The main components of GAP antibody drug conjugate technology are the synthetic cytotoxic agents and the stable linkers.

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