Biotech Tracker News - Seattle Genetics’ Clinical Pipeline is Not Its Most Compelling Asset
November 07, 2002 Two aspects of Seattle Genetics’ (NASDAQ: SGEN) business plan should be considered by investors. First, the company has several monoclonal antibodies in clinical trials. Second, it has a technology platform focused on the use of payloads to improve the efficacy of monoclonal antibodies. Today, Seattle Genetics updated investors on its clinical programs. The updates will not improve the outlook for this part of Seattle Genetics’ business, and none of Seattle Genetics’ clinical candidates is especially compelling. On the other hand, its technology platform is compelling, and should attract more attention in the next year as the interest in monoclonal antibody payloads increases among potential partners, and as investors regain interest in this type of business plan.  Updating its clinical pipeline, Seattle Genetics:  initiated a new trial of SGN-30, a cytotoxic antibody in development for Hodgkin disease (HD) and other lymphomas  slowed clinical development of SGN-15, a chemotherapy / monoclonal conjugate that has not demonstrated convincing efficacy to date for breast cancer and other tumors  cancelled development of SGN-10, which had been in trials for various solid tumors.  SGN-30  Seattle Genetics initiated a phase I/II multi-dose study of SGN-30. Safety, pharmacokinetic, and antitumor activity endpoints in the management of HD, anaplastic large cell lymphoma, and certain other lymphomas will be the focus of the investigation. The trial’s initiation comes on the heels of a single-dose study that provided reassurance of SGN-30’s safety and tolerability profiles over a range of doses and showed preliminary evidence of antitumor activity in some recipients.  SGN-30 is a monoclonal antibody that targets the CD30 protein. CD30 is highly expressed on a variety of hematologic tumors. Preclinical investigations suggest that the construct can directly kill HD cells, a property that other CD30-targeting antibodies have not exhibited. CD30 is also present on activated T cells, so the construct may be efficacious for some T cell-mediated inflammatory conditions as well. Preclinical investigation is ongoing in autoimmune disease. Our modeling estimates the probability of SGN-30’s FDA approval at 20-25%.  SGN-15  Seattle Genetics has abandoned SGN-15 development in combination with Taxotere for patients with breast cancer. To date, SGN-15 has not generated compelling preclinical or clinical data. In colorectal cancer, results were not strong enough to merit further study, although Seattle Genetics will look at SGN-15 in combination with chemotherapeutics other than Taxotere. Hormone refractory prostate carcinoma results looked more promising at this past May’s ASCO, but were preliminary. No results were available for breast and lung cancer studies at ASCO. Data from ongoing, mid-phase SGN-15 clinical trials in the management of cancers of the lung, ovary, and prostate are slated to be reported in the first half of 2003.  Doxorubicin, the chemotherapy conjugated to SGN-15, has significant adverse effects when administered systemically. These adverse effects include cardiotoxicity, bone marrow suppression, hair loss, nausea and vomiting, sun sensitivity, flushing, sore throat, bruising, bleeding, and fatigue. Minimization of these adverse effects in phase II and III trials of SGN-15 will be a key driver for the construct. So far, SGN-15 has shown some GI toxicity due to binding of the cells in the gut, but otherwise has avoided much of the toxicity associated with systemic administration of doxorubicin. Companies such as Alza (a subsidiary of Johnson & Johnson, NYSE: JNJ) and Schering-Plough (NYSE: SGP) have taken alternative approaches to maximizing doxorubicin’s therapeutic effects while minimizing adversities, and SGN-15 remains far from providing these products with competition.  Unfortunately, SGN-15’s magnitude of treatment effect is suspect. Only preservation of the magnitude of doxorubicin treatment effect with greater patient tolerance and fewer adverse dose limiting effects would move the program forward. Our modeling estimates the probability of SGN-15’s FDA approval at 15-25%.  SGN-10  Seattle Genetics has abandoned SGN-10 clinical trial development. The company was developing the monoclonal antibody fragment for the treatment of various solid tumors, including breast, colon, and pancreatic cancer.
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