Seattle Genetics, Inc. has initiated a phase I clinical trial of SGN-35 for patients with Hodgkin's disease and other CD30-positive hematologic malignancies.

SGN-35 is an antibody-drug conjugate (ADC) that utilizes Seattle Genetics' proprietary technology to empower antibodies by linking them to potent cell-killing drugs.

"SGN-35 represents an exciting, emerging class of antibody-based therapeutics," commented Clay B. Siegall, Ph.D., president and chief executive officer of Seattle Genetics. "Many antibodies lack sufficient potency on their own to have a therapeutic benefit. ADCs exploit an antibody's ability to target tumour cells to deliver a highly potent drug payload, sparing non-targeted cells many of the toxic effects of traditional chemotherapy. SGN-35 is the first auristatin-based ADC that Seattle Genetics has advanced into clinical trials, marking an important milestone for the company."

The single-agent, dose-escalation phase I study is designed to evaluate the safety, pharmacokinetic profile and antitumour activity of SGN-35 in patients with relapsed or refractory CD30-positive hematologic malignancies, including Hodgkin's disease. The trial is expected to enrol up to approximately 40 patients at multiple centers in the US.

"SGN-35 has the potential to address a significant unmet clinical need in the relapsed setting of Hodgkin's disease and CD30-positive T-cell lymphomas," said Andres Forero-Torres, M.D., associate professor in the division of hematology-oncology at the University of Alabama, Birmingham. "Currently, patients and their doctors have only limited therapeutic options and no approved antibody-based treatments."



SGN-35 is an ADC comprised of an anti-CD30 antibody joined by an enzyme cleavable linker to a potent, synthetic drug payload, monomethyl auristatin E (MMAE), using Seattle Genetics' proprietary technology. The ADC is designed to be stable in the bloodstream, but to release MMAE upon internalization into CD30-expressing tumour cells, resulting in a targeted cell-killing effect. Treatment with SGN-35 resulted in complete tumour regressions in preclinical models of Hodgkin's disease and anaplastic large cell lymphoma (ALCL).