Seattle Genetics is a biotechnology company focused on developing and commercializing innovative, empowered monoclonal antibody-based therapies for the treatment of cancer. The company, headquartered in Bothell, Washington (a suburb of Seattle), is the industry leader in antibody-drug conjugates or ADCs, a technology designed to harness the targeting ability of monoclonal antibodies to deliver cell-killing agents directly to cancer cells. Antibody-drug Conjugates are intended to spare non-targeted cells and thus reduce many of the toxic effects of traditional chemotherapy, while potentially enhancing antitumor activity.
The companys' flagship product Adcetris (Brentuximab vedotin) is commercially available for two indications in 50 countries, including the U.S., Canada, Japan and members of the European Union. The approval of Brentuximab vedotin makes it the first in a new class of ADCs.
To expand on the clinical opportunities of brentuximab vedotin, Seattle Genetics is conducting a broad clinical development program to evaluate its therapeutic potential in earlier lines of its approved indications as well as in a range of other lymphoma and non-lymphoma settings. The company is jointly developing brentuximab vedotin in collaboration with Takeda Pharmaceutical Company. Under the terms of the collaboration, Seattle Genetics has full commercialization rights to brentuximab vedotin in the United States and Canada. Takeda has exclusive rights to commercialize the product candidate in all other countries.
In addition to brentuximab vedotin, Seattle Genetics' product pipeline includes SGN-CD19A, an Antibody-drug conjugate (ADC) targeting CD19, SGN-CD33A, an ADC targeting CD33, SGN-LIV1A, an ADC targeting LIV-1, SGN-CD70A, an ADC targeting CD70, as well as ASG-22ME and ASG-15ME, ADCs that they are co-developing with Agensys (an affiliate of Astellas), an early-stage privately held biotechnology company based in Los Angeles, focusing on the development of fully human monoclonal antibodies to treat solid tumor cancers in a variety of cancer targets.
In January 2018, the business announced it would acquire Cascadian Therapeutics for $614 million.
Video Seattle Genetics
Collaboration Agreements
Seattle Genetics has collaboration agreements with Takeda Oncology Company (formerly Millennium) to develop and commercialize brentuximab vedotin. The company also has collaboration agreements for their ADC technology with a number of biotechnology and pharmaceutical companies, including, AbbVie, Bayer Celldex Therapeutics, Inc., Daiichi Sankyo, Genentech, Inc., GlaxoSmithKline, Pfizer, Inc. and PSMA Development Company LLC as well as ADC co-development agreements with Agensys, Inc., an affiliate of Astellas Pharma and Oxford BioTherapeutics Ltd.
Maps Seattle Genetics
Technology
MMAE-based
Seattle Genetics' proprietary Monomethyl auristatin E or MMAE-based antibody-drug conjugate technology, employed in brentuximab vedotin, empowers monoclonal antibodies to treat cancer. Brentuximab vedotin, for example, links the chimeric anti-CD30 monoclonal antibody (cAC10) via a protease-cleavable linker to MMAE. This ADC employs a linker system that is designed to be stable in the bloodstream but to release MMAE upon internalization into CD30-expressing tumor cells. This approach is intended to spare non-targeted (healthy) cells and thus reduce many of the toxic effects of traditional chemotherapy while potentially enhancing antitumor activity. (See also vedotins)
PBD based
Seattle Genetics is also evaluating another ADC technology using a highly potent cytotoxic agent called a pyrrolobenzodiazepine (PBD) dimer that kills cells by a different mechanism than auristatins (monomethyl auristatin E or monomethyl auristatin F). Pyrrolobenzodiazepine (PBD) dimer is currently employed in SGN-CD33A and SGN-CD70A. It is stably linked to an antibody with Seattle Genetics' site-specific engineered cysteines, resulting in uniform drug-loading of two PBD dimers per antibody.
Company history
Early years
Seattle Genetics was founded in 1997, by Clay Siegall, and is headquartered in Bothell, Washington, a suburb of Seattle. The company completed an initial public offering in March 2001, and is traded on the Nasdaq Stock Market under the symbol SGEN. As of December 2016, the company has more than 900 employees throughout the United States.
2009
- 19 February -- pivotal trial for Brentuximab vedotin for Hodgkin lymphoma
- 18 June -- phase II trial of Brentuximab vedotin for Anaplastic large cell lymphoma
- 24 July -- initiation of re-treatment clinical trial of Brentuximab vedotin
- 10 August -- milestone achievement in collaboration with MedImmune through initiation of phase I clinical trial of MEDI-547.
- 8 September -- milestone achievement in collaboration with Bayer for the submission of investigational new drug application with the FDA
- 5 October -- discontinuation of Phase IIb trial with Dazcetuzumab (also known as SGN-40 or huS2C6) for the treatment of diffuse Large B-cell lymphoma
- 16 November -- initiation of phase I clinical trial for SGN-75 (INN: vorsetuzumab mafodotin)
- 11 December -- termination of collaboration with Genentech for SGN-40
- 21 December -- announcement of new collaboration with GlaxoSmithKline ($12 million up front payment, up to $390 million in milestone payments)
In 2009, when it appeared that ADCETRIS could reach the market, the company realized that commercial skills would need to be grown in-house and/or acquired. This led to a decision to grow a commercial team to address the United States and Canadian markets, and a marketing collaboration with Takeda to cover the rest of the world. By 2018, however, the company was confident it could conduct a global commercialization venture.
2010
- 2 February -- initiation of phase I combination clinical trial of Brentuximab vedotin (SGN-35) for Hodgkin Lymphoma
- 3 March -- milestone achievement under collaboration with Genentech
- 8 April -- initiation of phase III trial for Brentuximab vedotin (SGN-35) for post transplant Hodgkin Lymphoma
- 20 April -- $9.5 million payment from Genentech to extend collaboration
- 20 July -- initiation of phase I clinical trial of ASG-5ME for treatment of Pancreatic cancer
- 3 August -- expansion of collaboration with Genentech ($12 million ufront payment, up to $900 million in potential fees and milestone payments)
- 2 September -- milestone achievement in collaboration with Agensys for initiation of phase I trial of AGS-16M8F
- 14 September -- entry into collaboration with Genmab
- 20 October -- initiation of phase I clinical tria; of ASG-5ME in prostate cancer treatment
2011
- 6 January -- entry into collaboration with Pfizer ($8 million upfront payment, $200+ million in potential milestone payments)
- 1 March -- initiation of phase I clinical trial of Brentuximab vedotin for use in conjunction with chemotherapy for treatment of systemic anaplastic large cell lymphoma
- 15 March -- expansion of collaboration with the Millennium Pharmaceuticals (Takeda Oncology)
- 22 March -- announcement of collaboration with Abbott ($8 million upfront payment, plus potential royalties and milestone payments)
- 19 April -- expansion of collaboration with Genmab
- 19 August accelerated FDA approval for Brentuximab vedotin for use in treatment of Hodgkin lymphoma and systemic anaplastic large cell lymphoma (ALCL)
- 23 August -- initiation of phase II trial of ADCETRIS in CD30-positive Non-Hodgkin Lymphoma
- 9 September -- collaboration with Oxford BioTherapeutics
- 25 October -- initiation of phase II clinical trial of ADCETRIS in CD30-positive non-Lymphoma malignancies
2012
- 4 June -- interim Phase I data from ASG-5ME in Prostate Cancer
- 5 July -- initiation of global phase III trial of ADCETRIS against CD30-expressing cutaneous T-cell lymphoma
- 24 August -- initiation of phase Ib trial of SGN-75 (INN: vorsetuzumab mafodotin) for use in combination with Everolimus in patients with renal cell carcinoma
- 9 October -- milestone achievement under collaboration with Genentech by advancements of two anti-body conjugates into phase II trials
- 17 October -- initiation of phase II trial of ADCETRIS in age 60+ Hodgkin Lymphoma patients
- 23 October -- expansion of collaboration with Abbott (upront payment of $25 million, milestone payment up to $220 million)
- 1 November -- initiation of global phase III trial of ADCETRIS in untreated advanced hodgkin lymphoma patients
- 26 November -- received Orphan drug designation for ADCETRIS treatment of mycosis fungoides
2013
- 1 February -- Health Canada approves ADCETRIS for treatment of relapsed refractory Hodgkin lymphoma
- 6 February -- initiation of two phase I trials of SGN-CD19A
- 25 June -- new collaboration with Bayer
- 15 July -- initiation of phase I trial of SGN-CD33A in treatment of Acute Myeloid Leukemia (AML)
- 15 August -- initiation of phase II trial of ADCETRIS for diffuse Large B-cell Lymphoma
- 21 October -- initiation of phase I trial of SGN-LIV1A for patients with LIV-1-positive metatstatic Breast cancer
2014
- 29 September -- Brentuximab vedotin was successfully used as a consolidation therapy in a late-stage trial for patients with a type of lymphatic cancer
- 8 December -- Data of Brentuximab Vedotin in Diffuse Large B-cell Lymphoma presented at the Annual Meeting of the American Society of Hematology
2015
- 12 January -- clinical collaboration with Bristol-Myers Squibb to evaluate combination of brentuximab vedotin and nivolumab in hematologic malignancies
- 18 February -- Supplemental Biologics License Application (BLA) for Brentuximab Vedotin in Post-Transplant Hodgkin Lymphoma Patients at High Risk of Relapse
- 8 June - collaboration with Unum Therapeutics to develop and commercialise its new antibody-coupled T-cell receptor (ACTR) therapies for cancer, generating up to $645 million for Unum.
- 31 December -- Adcetris sales increase to $226 million
2016
- 28 March -- the company announces it will develop 12 more drugs, employing another 100 staff
Awards and reception
Seattle Genetics was named number twenty-five on the list of Top 25 Biotech Companies of 2016.
Product portfolio & pipeline
- ADCETRIS used in the treatment of Hodgkin lymphoma and systemic anaplastic large cell lymphoma.
- SGN-75 - (INN: vorsetuzumab mafodotin; a humanized IgG1 monoclonal antibody conjugated via a non-cleavable maleimidocaproyl (mc) linker with monomethyl auristatin F (MMAF), used in Phase I trial of relapsed or refractory renal cell carcinoma patients or non-Hodgkin lymphoma patients.
- ASG-5ME - product candidate for the treatment of solid tumours (targets SLC44A4 in pancreatic, prostate and gastric cancer).
- Enfortumab vedotin (aka ASG-22ME, formerly ASG-22M6E) - product candidate for the treatment of solid tumours (targets Nectin-4 in bladder, breast, lung and pancreatic cancer); developed in 50-50 partnership with Astellas.
- SGN-CD19A - product candidate for the treatment of hematologic malignancies
References
Source of article : Wikipedia
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