Date: 2016-09-19
Type of information: Treatment of the first patient
phase: 1
Announcement: treatment of the first patient
Company: Seattle Genetics (USA - WA)
Product: SGN-CD123A
Action
mechanism: monoclonal antibody/antibody drug conjugate (ADC). SGN-CD123A is a novel ADC targeted to CD123 utilizing Seattle Genetics’ proprietary technology. CD123 is expressed across AML subtypes, including on leukemic stem cells, which are difficult to kill and may be responsible for high relapse rates even following intensive therapy. The CD123 antibody is attached to a highly potent DNA binding agent, a pyrrolobenzodiazepine (PBD) dimer, via a proprietary site-specific conjugation technology to a monoclonal antibody with engineered cysteines (EC-mAb). PBD dimers are significantly more potent than systemic chemotherapeutic drugs and the site-specific conjugation technology (EC-mAb) allows uniform drug-loading of the cell-killing PBD agent to the anti-CD123 antibody. The ADC is designed to be stable in the bloodstream and to release its potent DNA binding agent upon internalization into CD123-expressing cells.
Disease: relapsed or refractory acute myeloid leukemia
Therapeutic area: Cancer - Oncology
Country: USA
Trial
details: The study is a phase 1, open-label, multicenter, dose-escalation clinical trial. It will initially evaluate the maximum tolerated dose of SGN-CD123A, followed by an expansion cohort to further define safety and estimate anti-leukemic activity. In addition, the trial will assess pharmacokinetics, remission rate, duration of complete remission and overall survival. The study is designed to evaluate SGN-CD123A administered every three weeks and will enroll up to approximately 100 relapsed or refractory patients at multiple centers in the United States. (NCT02848248)
Latest
news: * On September 19, 2016, Seattle Genetics announced enrollment of the first patient in a multicenter phase 1 clinical trial of SGN-CD123A for patients with relapsed or refractory acute myeloid leukemia (AML). SGN-CD123A is an investigational antibody-drug conjugate (ADC) targeted to CD123 utilizing Seattle Genetics’ proprietary technology, an engineered cysteine antibody (EC-mAb) stably linked to a highly potent DNA binding agent called a pyrrolobenzodiazepine (PBD) dimer. CD123 is expressed across AML subtypes, including leukemic stem cells, which are difficult to kill and may be responsible for high relapse rates even following intensive therapy. The trial is designed to assess the safety and anti-leukemic activity of SGN-CD123A. SGN-CD123A represents Seattle Genetics’ second clinical-stage program in development for AML, reflecting the company’s commitment to addressing the significant unmet need for these patients. Preclinical SGN-CD123A data presented at the 2015 American Society of Hematology (ASH) Annual Meeting demonstrated enhanced anti-leukemic activity across multiple AML disease models, including those typically resistant to chemotherapy. With more than 15 years of experience and innovation, Seattle Genetics is the leader in ADC development. ADCs are designed to selectively deliver cell-killing agents to tumor cells, and thus reduce many of the toxic effects of traditional chemotherapy while enhancing antitumor activity.
