A leader in antibody-drug conjugates, a new type of targeted therapy, Seattle Genetics Inc. (SGEN) is getting closer to its dream of transforming from an R&D-only operation into a commercial-stage company, if things pan out the way as expected.
The antibody-drug conjugate technology, or ADC for short, represents the next step in improving antibody-based therapies, which revolutionized the treatment of cancer by targeting malignant cells and limiting damage to normal tissue. The ADC technology empowers monoclonal antibodies targeted to tumor cells by attaching them to potent cytotoxic (cell-killing) agents. The approach of empowered antibodies is meant to spare non-targeted cells and simultaneously give more tumor-killing punch to the cancerous cells.
Seattle Genetics' first and lead ADC program is Brentuximab vedotin that targets CD30, a defining marker of hodgkin lymphoma. CD30, a protein that belongs to the tumor necrosis factor receptor family, is also expressed on other cancers, including anaplastic large cell lymphoma.
Last month, the FDA accepted for filing the company's two biologics license applications for Brentuximab vedotin, with the proposed trade name ADCETRIS, seeking approval for two indications, namely relapsed or refractory hodgkin lymphoma and relapsed or refractory systemic anaplastic large cell lymphoma.
The biologics license applications were submitted based on the results from two key trials, which evaluated Brentuximab vedotin in hodgkin lymphoma patients and anaplastic large cell lymphoma patients. In both trials, more than 90 percent of patients had reductions in the size of their tumors.
According to the trial results, 75 percent of hodgkin lymphoma patients achieved an objective response, including 34 percent complete remissions, and 86 percent of ALCL patients achieved an objective response, including 53 percent complete remissions. Apart from the remarkable clinical activity, the adverse events associated with Brentuximab vedotin were also manageable.
Being the first in a new class of antibody-drug conjugates, the biologics license applications for Brentuximab vedotin is scheduled to be reviewed by the Oncologic Drugs Advisory Committee on July 14. With both the biologics license applications for Brentuximab vedotin having a priority review status, the FDA is expected to make a final decision on the empowered antibody drug on August 30, 2011.
According to the American Cancer Society, about 8,500 cases of hodgkin lymphoma were diagnosed in the U.S. last year. About 2,000 additional patients per year are diagnosed with systemic anaplastic large cell lymphoma. Studies indicate that two thirds of patients with advanced Hodgkin's are cured with chemotherapy, radiation, or a combination. However, the company believes that newly relapsed or refractory Hodgkin lymphoma and sALCL patient population of 8,000 to 9,000 would potentially be eligible for treatment with brentuximab vedotin.
Brentuximab vedotin has an orphan drug designation in the U.S. and Europe for the treatment of hodgkin lymphoma and anaplastic large cell lymphoma. A marketing authorization application for Brentuximab vedotin is expected to be submitted to the European Medicines Agency in the first half of 2011.
If approved, RBC Capital Markets analyst Jason Kantor expects Brentuximab vedotin to generate annual sales of $420 million by 2015.
Seattle Genetics has a collaboration with Millennium: The Takeda Oncology Co. for the development of Brentuximab vedotin that was inked in late 2009. While Seattle Genetics has retained all commercial rights for Brentuximab vedotin in the United States and its territories and in Canada, Millennium has commercial rights for the drug in the rest of the world.
The concept of ADC has been in vogue for the past 30 years. The first and only marketed ADC in the U.S. was Mylotarg, developed by Pfizer Inc.'s (PFE) Wyeth unit, which was given accelerated approval in May 2000 to treat elderly patients with relapsed acute myeloid leukemia. However, with the drug failing to demonstrate clinical benefit and proving to be fatal in patients in a post marketing study, Pfizer withdrew Mylotarg from the U.S. market last June. The drug was never approved for use in Europe.
Yet another ADC in advanced development is trastuzumab-DM1, or T-DM1, being developed by Roche's Genentech Inc. division with technology from ImmunoGen Inc. (IMGN). T-DM1 suffered a regulatory setback in August 2010 with the FDA refusing to review the BLA for T-DM1 unless more results are presented. Genentech expects to submit a new BLA for T-DM1 in mid-2012.
Apart from evaluating Brentuximab vedotin in hodgkin lymphoma and anaplastic large cell lymphoma, Seattle Genetics is also focused in expanding the compound's therapeutic potential.
The following are the ongoing trials of Brentuximab vedotin:
- A phase III study, dubbed the AETHERA trial, evaluates Brentuximab vedotin in patients at high risk of residual hodgkin lymphoma following stem cell transplant. The study, which was initiated in April 2010, is currently recruiting patients, and the collection of primary outcome measure is expected to be completed by June 2013- A phase II study evaluates the potential for retreatment with Brentuximab vedotin in patients who have relapsed after discontinuing previous Brentuximab vedotin therapy. The study was initiated in July 2009 with completion expected in July 2012- A phase I trial investigating Brentuximab vedotin in combination with multi-agent chemotherapy in newly diagnosed hodgkin lymphoma patients. The study was started in January 2010 and is expected to be completed by November 2012- A phase I trial evaluating Brentuximab vedotin as front-line therapy in systemic anaplastic large cell lymphoma when administered sequentially and combined with multi-agent chemotherapy. The study was initiated as recently as February of this year with the collection of the final primary outcome measure expected to be completed by December 2012.
Now, for the other investigational drugs in the pipeline...
- SGN-75, undergoing a phase I trial for metastatic renal cell carcinoma and relapsed or refractory non-Hodgkin lymphoma. The study was initiated in November 2009 and collection of the final primary outcome measure is expected to be completed by January 2012- ASG-5ME, which is under a phase I trial, for pancreatic cancer and prostate cancer- ASG-22ME, under phase I trial in solid tumors. Seattle Genetics is co-developing ASG-5ME and under a joint development agreement with Agensys, an affiliate of Astellas Pharma Inc.- Dacetuzumab (SGN-40), under phase Ib-IIb combination trials for non-Hodgkin lymphoma and multiple myeloma- SGN-70, which has completed a phase I dose-escalation trial.
A quick look at the company's balance sheet...
Seattle Genetics has no marketed drugs and has generated revenues principally from its collaboration and license agreements to date. The company's ADC collaboration includes, Abbott Biotechnology Ltd., Bayer Pharmaceuticals Corp., Celldex Therapeutics, Inc., Daiichi Sankyo Co., Ltd., Genentech, Inc., a member of the Roche Group, GlaxoSmithKline LLC, Millennium, Pfizer, Inc., and PSMA Development Company LLC, a subsidiary of Progenics Pharmaceuticals Inc., as well as ADC co-development agreements with Agensys, Inc., an affiliate of Astellas Pharma, Inc., and Genmab A/S.
As of March 31, 2011, Seattle Genetics had an accumulated deficit of $494.6 million, cash of $455.9 million and total stockholders' equity of $304.8 million.
Shares of Seattle Genetics have gained more than 31% year-to-date. A new 52-week intra day high of $20.46 was set on Monday (June 20). The stock is currently down 1.30% at $19.75.
Updated on July 14
The FDA panel voted 10-0 to recommend that the FDA grant accelerated approval of ADCETRIS (brentuximab vedotin) for the treatment of patients with Hodgkin lymphoma who relapse after autologous stem cell transplant as well as for the treatment of patients with relapsed or refractory systemic anaplastic large cell lymphoma.
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