Seattle Genetics, Inc. (Nasdaq: SGEN) today presented interim phase 1 clinical data from SGN-CD19A, an antibody-drug conjugate (ADC) in development for the treatment of B-cell malignancies, including acute lymphoblastic leukemia (ALL), at the 55 th American Society of Hematology (ASH) Annual Meeting and Exposition taking place in New Orleans, Louisiana, December 7-10, 2013. SGN-CD19A is an ADC targeting CD19, a protein expressed uniformly on almost all B-cell malignancies. ADCs are monoclonal antibodies that are designed to selectively deliver cytotoxic agents to tumor cells. This approach is intended to spare non-targeted cells and thus reduce many of the toxic effects of traditional chemotherapy while enhancing antitumor activity.
“The phase 1 trial evaluating SGN-CD19A has demonstrated encouraging early antitumor activity and a generally well-tolerated safety profile among heavily pretreated patients with acute lymphoblastic leukemia and very aggressive types of lymphoma. In addition, multiple complete remissions have been observed in a parallel phase 1 study evaluating SGN-CD19A in aggressive non-Hodgkin lymphoma. Dose-escalation is ongoing in both phase 1 clinical trials, and we plan to report additional data during 2014,” said Jonathan Drachman, M.D., Chief Medical Officer and Executive Vice President, Research and Development at Seattle Genetics. “Across our six internal clinical development-stage ADCs and more than a dozen collaborator programs, our industry-leading technology continues to empower innovative candidates in development as potential treatment options for patients.”
With over a decade of experience and knowledge in ADC innovation, Seattle Genetics is the leader in developing ADCs, a technology designed to harness the targeting ability of antibodies to deliver cell-killing agents directly to cancer cells. Of the approximately 30 ADC candidates in clinical development across the biotechnology and pharmaceutical industry, more than 18 utilize Seattle Genetics’ proprietary ADC technology.
A First-in-Human Phase 1 Study of the Antibody-Drug Conjugate SGN-CD19A in Relapsed or Refractory B-Lineage Acute Leukemia and Highly Aggressive Lymphoma (Abstract #1437)Data were reported from 16 adult patients and four pediatric patients with relapsed or refractory B-lineage ALL and highly aggressive lymphoma, including B-cell lymphoblastic lymphoma (B-LBL) and Burkitt lymphoma. The median age of adult patients was 46 years and the median number of prior systemic therapies was two, with six patients (38 percent) having received a prior allogeneic stem cell transplant. The median age of pediatric patients was 14 years and the median number of prior systemic therapies was three, with two patients (50 percent) having received a prior allogeneic stem cell transplant.