Seattle Genetics, Inc. and Laureate Pharma, Inc. have announced that they have entered into an agreement for manufacturing of Seattle Genetics' SGN-33 and SGN-70 humanized monoclonal antibody product candidates.
Under the terms of the agreement, Laureate Pharma will perform scale-up and cGMP manufacturing of clinical trial materials for both programs.
"These manufacturing campaigns are an important part of our 2006 development activities and will provide clinical-grade drug product to support both our rapid advancement of SGN-33 in ongoing clinical trials and our planned initiation of SGN-70 clinical trials in 2007," said Morris Rosenberg, D.Sc., Senior Vice President, Development at Seattle Genetics.
"We are pleased to be working with Laureate Pharma, a company with demonstrated expertise in biopharmaceutical manufacturing, including capabilities in both clinical and commercial-grade materials."
"We are excited to apply our expertise in monoclonal antibody development and cGMP production to Seattle Genetics' innovative product candidates," said Robert J. Broeze, Ph.D., President and Chief Executive Officer of Laureate Pharma.
"Our relationship with Seattle Genetics and its pipeline of potential new cancer therapies furthers our strategic objective of working with innovative partners and products."
SGN-33 (HuM195; lintuzumab) is a humanized monoclonal antibody that targets the CD33 antigen, which is highly expressed on a number of hematologic malignancies and several myeloproliferative disorders, but has limited expression on normal tissue.
Seattle Genetics is currently conducting a phase I clinical trial of SGN-33 for the treatment of acute myeloid leukemia or myelodysplastic syndromes (MDS).
The single agent study is designed to assess the tolerability, pharmacokinetic profile and antitumor activity of escalating doses of SGN-33 in patients who are not eligible for intensive chemotherapy or stem cell transplantation, or those who have failed previous therapy.
The company plans to complete the dose-escalation portion of the phase I study by the end of 2006.
SGN-70 is a humanized anti-CD70 monoclonal antibody that has demonstrated antitumor activity and potent effector functions in preclinical models of hematologic malignancies.
Seattle Genetics is conducting preclinical development of SGN-70 and plans to file an investigational new drug (IND) application for the program during 2007.
Clinical material manufactured for the SGN-70 program will also support future clinical development of SGN-75, which is an ADC comprised of the SGN-70 monoclonal antibody linked to an auristatin derivative using the company's proprietary ADC technology.
SGN-75 is efficacious and well tolerated in preclinical models of renal cell cancer and also has potential application in various hematologic malignancies.