Seahle Genetics’ Innovative Antibody-drug Conjugate SGN-CD48A Entered Clinical D

Posted by Candy Swift on May 30th, 2019

Seahle Genetics recently announced the launch of a Phase I clinical study evaluating the efficacy and safety of the anticancer drug SGN-CD48A in the treatment of relapsed or refractory multiple myeloma (MM). SGN-CD48A is an experimental antibody drug conjugate (ADC) targeting the CD48 protein, which is highly expressed on the surface of MM cells.

Seattle Genetics is a biotechnology company focused on developing and commercializing innovative, empowered monoclonal antibody-based therapies for the treatment of cancer. The company, headquartered in Bothell, Washington (a suburb of Seattle), is engaged in antibody-drug conjugates or ADCs, a technology designed to harness the targeting ability of monoclonal antibodies to deliver cell-killing agents directly to cancer cells. Antibody-drug Conjugates are intended to spare non-targeted cells and thus reduce many of the toxic effects of traditional chemotherapy, while potentially enhancing antitumor activity.

Multiple myeloma, also known as plasma cell myeloma, is a cancer of plasma cells, a type of white blood cell normally responsible for producing antibodies. Often, no symptoms are noticed initially. When advanced, bone pain, bleeding, frequent infections, and anemia may occur. Complications may include amyloidosis.

ADC is a novel therapeutic drug that is increasingly being watched by pharmaceutical companies around the world. ADC drug is produced by the conjugation of monoclonal antibodies and toxic drugs through biologically active ADC linker, and are potent anti-cancer drugs targeted to cancer cells. Because of its accurate identification of target sites and non-cancerous cells, it greatly improves drug efficacy and reduces toxic and side effects.

The SGN-CD48A incorporates a new generation of PEGylated glucoside linkers, the latest ADC technology innovation from Seattle Genetics, to improve drug stability in the blood circulatory system and reduce off-target absorption while enabling a higher number (8 molecules) of MMAE (monomethyl auristatin E) is conjugated to each CD48-targeting monoclonal antibody molecule, and the drug releases more MMAE to inhibit cell division by inhibiting the polymerization of tubulin when it is internalized by CD48-positive tumor cells. Using this novel linker, SGN-48A has shown strong antitumor activity in preclinical studies.

This Phase I clinical study (NCT03379584) is a multicenter, open-label and dose-escalation study that plans to recruit approximately 75 patients with relapsed or refractory MM. In the study, the initial dose of SGN-CD48A was administered every 3 weeks. The main purpose of the study was to evaluate the safety and tolerability of SGN-CD48A as monotherapy, and to determine the maximum tolerated dose (MTD) of the drug. Key secondary endpoints included assessment of anti-tumor activity of SGN-CD48A and determination of recommended single-dose doses and treatment regimens.

About Creative Biolabs

Established in 2004, Creative Biolabs is highly specialized in advanced antibody biochemistry and engineering. With more than a decade of exploration and expansion, our current research and service capacity covers the entire new drug discovery and development pipeline, ranging from early discovery, preclinical evaluations, cGMP manufacturing, to clinical trials. As an international cooperation, we have established offices all around the globe with more than 200 well-trained full-time scientists and technicians, who work closely with our customers and research partners to develop new medicines for a better, healthier world.