Seattle Genetics

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Seattle Genetics
Public
Traded as NASDAQSGEN
Industry Biotechnology, Pharmaceutical
Founded Incorporated 15 July 1997
Headquarters Bothell, Washington, United States
Key people
Clay B. Siegall Ph.D
(Chairman, President & CEO)
Todd E. Simpson
(CFO
Eric L. Dobmeier
(Chief Operating Officer)
Jean Liu
(Executive Vice President Legal Affairs, General Counsel, Corporate Secretary)
Jonathan Drachman M.D.
(Chief Medical Officer) and Executive Vice President of R&D)
Vaughn Himes
(Executive Vice President) Technical Operations and Process Sciences
Charles Romp
(Senior Vice President) Sales
Felix Baker
Lead Independent Director
Pinkston Peggy
Senior Director Corporate Communications
Products Brentuximab vedotin and other Antibody-drug conjugates
Number of employees
> 650
Website www.seattlegenetics.com

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) [1] 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 [2] 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.

Collaboration Agreements[edit]

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.[3]

Technology[edit]

MMAE-based[edit]

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[edit]

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[edit]

Early years[edit]

Seattle Genetics was founded in 1997 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. To date, the company has more than 650 employees throughout the United States.

2009[edit]

19 February — pivotal trial for Brentuximab vedotin for Hodgkin lymphoma[4]
18 June — phase II trial of Brentuximab vedotin for Anaplastic large cell lymphoma[5]
24 July — initiation of re-treatment clinical trial of Brentuximab vedotin[6]
10 August — milestone achievement in collaboration with MedImmune through initiation of phase I clinical trial of MEDI-547.[7][8]
8 September — milestone achievement in collaboration with Bayer for the submission of investigational new drug application with the FDA[9]
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[10]
16 November — initiation of phase I clinical trial for SGN-75 (INN: vorsetuzumab mafodotin)[11]
11 December — termination of collaboration with Genentech for SGN-40[12]
21 December — announcement of new collaboration with GlaxoSmithKline ($12 million up front payment, up to $390 million in milestone payments)[13]

2010[edit]

2 February — initiation of phase I combination clinical trial of Brentuximab vedotin (SGN-35) for Hodgkin Lymphoma[14]
3 March — milestone achievement under collaboration with Genentech[15]
8 April — initiation of phase III trial for Brentuximab vedotin (SGN-35) for post transplant Hodgkin Lymphoma[16]
20 April — $9.5 million payment from Genentech to extend collaboration[17]
20 July — initiation of phase I clinical trial of ASG-5ME for treatment of Pancreatic cancer[18]
3 August — expansion of collaboration with Genentech ($12 million ufront payment, up to $900 million in potential fees and milestone payments)[19]
2 September — milestone achievement in collaboration with Agensys for initiation of phase I trial of AGS-16M8F[20][21]
14 September — entry into collaboration with Genmab[22]
20 October — initiation of phase I clinical tria; of ASG-5ME in prostate cancer treatment[23]

2011[edit]

6 January — entry into collaboration with Pfizer ($8 million upfront payment, $200+ million in potential milestone payments)[24]
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 [25]
15 March — expansion of collaboration with the Millennium Pharmaceuticals (Takeda Oncology)[26]
22 March — announcement of collaboration with Abbott ($8 million upfront payment, plus potential royalties and milestone payments)[27]
19 April — expansion of collaboration with Genmab[28]
19 August accelerated FDA approval for Brentuximab vedotin for use in treatment of Hodgkin lymphoma and systemic anaplastic large cell lymphoma (ALCL)[29]
23 August — initiation of phase II trial of ADCETRIS in CD30-positive Non-Hodgkin Lymphoma[30]
9 September — collaboration with Oxford BioTherapeutics [31]
25 October — initiation of phase II clinical trial of ADCETRIS in CD30-positive non-Lymphoma malignancies[32]

2012[edit]

4 June — interim Phase I data from ASG-5ME in Prostate Cancer [33]
5 July — initiation of global phase III trial of ADCETRIS against CD30-expressing cutaneous T-cell lymphoma[34]
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[35]
9 October — milestone achievement under collaboration with Genentech by advancements of two anti-body conjugates into phase II trials[36]
17 October — initiation of phase II trial of ADCETRIS in age 60+ Hodgkin Lymphoma patients[37]
23 October — expansion of collaboration with Abbott (upront payment of $25 million, milestone payment up to $220 million)[38]
1 November — initiation of global phase III trial of ADCETRIS in untreated advanced hodgkin lymphoma patients [39]
26 November — received Orphan drug designation for ADCETRIS treatment of mycosis fungoides[40]

2013[edit]

1 February — Health Canada approves ADCETRIS for treatment of relapsed refractory Hodgkin lymphoma[41]
6 February — initiation of two phase I trials of SGN-CD19A[42]
25 June — new collaboration with Bayer[43]
15 July — initiation of phase I trial of SGN-CD33A in treatment of Acute Myeloid Leukemia (AML)[44]
15 August — initiation of phase II trial of ADCETRIS for diffuse Large B-cell Lymphoma[45][46]
21 October — initiation of phase I trial of SGN-LIV1A for patients with LIV-1-positive metatstatic Breast cancer[47][48]

2014[edit]

29 September — Brentuximab vedotin was successfully used as a consolidation therapy in a late-stage trial for patients with a type of lymphatic cancer [49]
8 December — Data of Brentuximab Vedotin in Diffuse Large B-cell Lymphoma presented at the Annual Meeting of the American Society of Hematology [50]

2015[edit]

12 January  — clinical collaboration with Bristol-Myers Squibb to evaluate combination of brentuximab vedotin and nivolumab in hematologic malignancies [51]
18 February  — Supplemental Biologics License Application (BLA) for Brentuximab Vedotin in Post-Transplant Hodgkin Lymphoma Patients at High Risk of Relapse [52]
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.[53]
31 December — Adcetris sales increase to $226 million[54]

2016[edit]

28 March  — the company announces it will develop 12 more drugs, employing another 100 staff[54]

Product portfolio & pipeline[edit]

ADCETRIS[1] used in the treatment of Hodgkin lymphoma and systemic anaplastic large cell lymphoma.[55]
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.[56]
ASG-5ME – product candidate for the treatment of solid tumours (targets SLC44A4 in pancreatic, prostate and gastric cancer).
ASG-22ME – product candidate for the treatment of solid tumours (targets Nectin-4 in bladder, breast, lung and pancreatic cancer).[57][58]
SGN-CD19A – product candidate for the treatment of hematologic malignancies

References[edit]

  1. ^ a b Brentuximab vedotin (SGN35), ADC Review/Journal of Antibody-drug Conjugates
  2. ^ Brentuximab vedotin (ADCETRIS®) Clinical Trials, ADC Review/Journal of Antibody-drug Conjugates
  3. ^ Seattle Genetics Corporate Profile Reuters
  4. ^ Seattle Genetics Initiates Pivotal Trial of SGN-35 for Hodgkin Lymphoma Corporate Press Release
  5. ^ Seattle Genetics Initiates Phase II Trial of SGN-35 for Anaplastic Large Cell Lymphoma Corporate Press Release
  6. ^ Seattle Genetics Initiates Brentuximab Vedotin (SGN-35) Retreatment Clinical Trial Corporate Press Release
  7. ^ Seattle Genetics Achieves Milestone Under Antibody-Drug Conjugate Collaboration with MedImmune Corporate Press Release
  8. ^ Phase 1, open-label study of MEDI-547 in patients with relapsed or refractory solid tumors Annunziata CM, Kohn EC, LoRusso P, Houston ND, Coleman RL, Buzoianu M, Robbie G, Lechleider R Invest New Drugs. 2013 Feb;31(1):77-84. doi: 10.1007/s10637-012-9801-2. Epub 2012 Feb 28.
  9. ^ Seattle Genetics Achieves Milestone Under Antibody-Drug Conjugate Collaboration With Bayer Schering Pharma Corporate Press Release
  10. ^ Seattle Genetics Announces Discontinuation of Dacetuzumab Phase IIb Diffuse Large B-Cell Lymphoma Clinical Trial Corporate Press Release
  11. ^ Seattle Genetics Initiates Phase I Clinical Trial of Antibody-Drug Conjugate SGN-75 Corporate Press Release
  12. ^ Seattle Genetics Announces Termination of Collaboration Agreement with Genentech for Dacetuzumab (SGN-40) Corporate Press Release
  13. ^ Seattle Genetics Announces Antibody-Drug Conjugate Collaboration with GlaxoSmithKline Corporate Press Release
  14. ^ Seattle Genetics and Millennium Announce Initiation of Phase I Combination Clinical Trial of Brentuximab Vedotin (SGN-35) for Front-line Hodgkin Lymphoma Corporate Press Release
  15. ^ Seattle Genetics Achieves Milestone under Antibody-Drug Conjugate Collaboration with Genentech Corporate Press Release
  16. ^ Seattle Genetics, Takeda and Millennium Announce Initiation of Phase III AETHERA Trial of Brentuximab Vedotin (SGN-35) for Post-Transplant Hodgkin Lymphoma Corporate Press Release
  17. ^ Seattle Genetics to Receive $9.5 Million Payment from Genentech to Extend Antibody-Drug Conjugate Collaboration Corporate Press Release
  18. ^ Seattle Genetics and Agensys, an Affiliate of Astellas, Announce Initiation of Phase I Clinical Trial of ASG-5ME for Pancreatic Cancer Corporate Press Release
  19. ^ Seattle Genetics Expands Antibody-Drug Conjugate Collaboration with Genentech Corporate Press Release
  20. ^ Seattle Genetics Achieves Milestone under Antibody-Drug Conjugate Collaboration with Agensys, an Affiliate of Astellas Corporate Press Release
  21. ^ Abstract 2436: AGS-16M8F is a novel antibody drug conjugate (ADC) for treating renal and liver cancers; Gudas JM, Torgov M, An Z, Jia XC, Morrison KJ, Morrison RK, Yang P, et al. Cancer Res April 15, 2010 70; 2436. Last Accessed: February 15, 2011
  22. ^ Genmab and Seattle Genetics Enter Into Antibody-Drug Conjugate Research Collaboration Corporate Press Release
  23. ^ Agensys, an Affiliate of Astellas, and Seattle Genetics Announce Initiation of Phase I Clinical Trial of ASG-5ME for Prostate Cancer Corporate Press Release
  24. ^ Seattle Genetics Announces Antibody-Drug Conjugate Collaboration with Pfizer Corporate Press Release
  25. ^ Seattle Genetics and Millennium Announce Initiation of a Phase I Clinical Trial of Brentuximab Vedotin in Combination with Chemotherapy for Front-line Systemic ALCL Corporate Press Release
  26. ^ Seattle Genetics and Millennium Expand Antibody-Drug Conjugate Collaboration Corporate Press Release
  27. ^ Seattle Genetics Announces Antibody-Drug Conjugate Collaboration with Abbott Corporate Press Release
  28. ^ Genmab and Seattle Genetics Expand Antibody-Drug Conjugate Collaboration Corporate Press Release
  29. ^ Seattle Genetics Announces FDA Accelerated Approval of ADCETRIS(TM) (Brentuximab Vedotin) for Two Indications Corporate Press Release
  30. ^ Seattle Genetics Announces Initiation of a Phase II Clinical Trial of ADCETRIS(TM) in CD30-Positive Non-Hodgkin Lymphoma Corporate Press Release
  31. ^ Seattle Genetics and Oxford BioTherapeutics to Collaborate on Antibody-Drug Conjugates for Cancer Corporate Press Release
  32. ^ Seattle Genetics Announces Initiation of a Phase II Clinical Trial of ADCETRIS(TM) in CD30-Positive Non-Lymphoma Malignancies Corporate Press Release
  33. ^ Agensys and Seattle Genetics Announce Interim Phase I Data from ASG-5ME Clinical Trial for Prostate Cancer Astellas Press Release
  34. ^ Millennium and Seattle Genetics Initiate Global Phase 3 Trial of ADCETRIS™ in Patients with CD30-Expressing Relapsed Cutaneous T-cell Lymphoma Corporate Press Release
  35. ^ Seattle Genetics Announces Initiation of a Phase Ib Trial of SGN-75 in Combination with Everolimus for Patients with Renal Cell Carcinoma Corporate Press Release
  36. ^ Seattle Genetics Achieves Milestones as Genentech Advances Two Antibody-Drug Conjugates (ADCs) into Phase II Development Corporate Press Release
  37. ^ Seattle Genetics Announces Initiation of Phase II Trial of ADCETRIS® as Front-line Therapy for Hodgkin Lymphoma Patients Age 60 and Over Corporate Press Release
  38. ^ Seattle Genetics Expands Antibody-Drug Conjugate Collaboration with Abbott Corporate Press Release
  39. ^ Millennium and Seattle Genetics Initiate Global Phase 3 Clinical Trial of ADCETRIS® in Previously Untreated Advanced Hodgkin Lymphoma Corporate Press Release
  40. ^ Seattle Genetics Receives FDA Orphan Drug Designation for ADCETRIS® (Brentuximab Vedotin) in Mycosis Fungoides Corporate Press Release
  41. ^ Health Canada Approves ADCETRIS® (Brentuximab Vedotin) for the Treatment of Relapsed or Refractory Hodgkin Lymphoma (HL) and Systemic Anaplastic Large Cell Lymphoma (sALCL) Corporate Press Release
  42. ^ Seattle Genetics Initiates Two Phase I Trials of SGN-CD19A Corporate Press Release
  43. ^ Seattle Genetics Enters Into New Antibody-Drug Conjugate Collaboration with Bayer Corporate Press Release
  44. ^ Seattle Genetics Initiates Phase 1 Trial of SGN-CD33A in Acute Myeloid Leukemia (AML) Corporate Press Release
  45. ^ Seattle Genetics Announces Initiation of Phase 2 Trial of ADCETRIS® (Brentuximab Vedotin) in Combination with Current Standard of Care for Frontline Diffuse Large B-Cell Lymphoma (DLBCL) Corporate Press Release
  46. ^ B-cell lymphoma NCI Dictionary of Cancer Terms; Last Accessed February 18, 2015
  47. ^ Seattle Genetics Initiates Phase 1 Trial of ADC Candidate, SGN-LIV1A, for Patients with LIV-1-Positive Metastatic Breast Cancer Corporate Press Release
  48. ^ Phase I Trial of SGN-LIV1A Initiated in LIV-1-positive metastatic breast cancer ADC Review / Journal of Antibody-drug Conjugates. October 22, 2013. Last accessed October 23, 2013
  49. ^ Seattle Genetics, Takeda's cancer drug meets main goal in trial Reuters
  50. ^ Seattle Genetics Presents ADCETRIS® (Brentuximab Vedotin) Data in Diffuse Large B-cell Lymphoma at ASH Annual Meeting Reuters
  51. ^ Seattle Genetics and Bristol-Myers Squibb Announce Clinical Collaboration to Evaluate Combination of Adcetris® (Brentuximab Vedotin) and Opdivo® (Nivolumab) in Hematologic Malignancies Reuters
  52. ^ Supplemental BLA for Brentuximab Vedotin in Post-Transplant Hodgkin Lymphoma Patients at High Risk of Relapse ADC Review / Journal of Antibody-drug Conjugates, Last accessed February 19, 2015
  53. ^ "Seattle Genetics, Unum Partner on Cancer Immunotherapies in Up-to-$645M Deal - GEN Genetic Engineering & Biotechnology News - Biotech from Bench to Business - GEN". 
  54. ^ a b http://www.bizjournals.com/seattle/blog/health-care-inc/2016/03/seattle-genetics-ambitious-plan-for-12-more-drugs.html
  55. ^ Brentuximab Vedotin (SGN-35) in Patients With Relapsed or Refractory Systemic Anaplastic Large-Cell Lymphoma: Results of a Phase II Study JCO June 20, 2012 vol. 30 no. 18 2190-2196
  56. ^ IMGT/mAb-DB SGN-75 Poiron, C. et al., JOBIM 2010, Paper 13 (2010).
  57. ^ Enfortumab Vedotin (ASG-22ME, Formerly AGS-22M6E) Clinical trials ADC Review / Journal of Antibody-drug Conjugates; Last accessed February 18, 2015
  58. ^ Anti-Nectin-4 monoclonal antibody-drug conjugate AGS-22M6E National Cancer Institute (NCI) Drug Dictionary