Seattle Genetics

Last updated

Seattle Genetics, Inc.
Public
Traded as
Industry Biotechnology, pharmaceutical
FoundedIncorporated 15 July 1997
Headquarters Bothell, Washington, United States
Key people
Products Brentuximab vedotin and other antibody-drug conjugates
RevenueIncrease2.svg US$ 654.7 million (2018)
Number of employees
> 900
Website 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.

Contents

The company's flagship product Adcetris (Brentuximab vedotin) [2] is commercially available for four indications in more than 65 countries, including the U.S., Canada, Japan and members of the European Union.

To expand on the clinical opportunities of brentuximab vedotin, Seattle Genetics is conducting a broad clinical development program [3] 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 enfortumab vedotin, being co-developed with Astellas Pharma, tisotumab vedotin, being co-developed with Genmab, SGN-LIV1A, an ADC targeting LIV-1, and several immuno-oncology agents in phase 1 studies.

In January 2018, the business announced it would acquire Cascadian Therapeutics for $614 million. [4]

In September 2020, Merck & Co announced it would purchase $1 billion of Seattle's common stock, with both companies co-developing lead treatment: ladiratuzumab vedotin. [5]

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. [6]

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)

Company history

Early years

Seattle Genetics was founded in 1997, by Clay Siegall, [1] 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. [7] [8]

2009

19 February: pivotal trial for Brentuximab vedotin for Hodgkin lymphoma [9]
18 June: phase II trial of Brentuximab vedotin for Anaplastic large cell lymphoma [10]
24 July: initiation of re-treatment clinical trial of Brentuximab vedotin [11]
10 August: milestone achievement in collaboration with MedImmune through initiation of phase I clinical trial of MEDI-547. [12] [13]
8 September: milestone achievement in collaboration with Bayer for the submission of investigational new drug application with the FDA [14]
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 [15]
16 November: initiation of phase I clinical trial for SGN-75 (INN: vorsetuzumab mafodotin) [16]
11 December: termination of collaboration with Genentech for SGN-40 [17]
21 December: announcement of new collaboration with GlaxoSmithKline ($12 million up front payment, up to $390 million in milestone payments) [18]

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. [1] 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. [1] By 2018, however, the company was confident it could conduct a global commercialization venture. [1]

2010

2 February: initiation of phase I combination clinical trial of Brentuximab vedotin (SGN-35) for Hodgkin Lymphoma [19]
3 March: milestone achievement under collaboration with Genentech [20]
8 April: initiation of phase III trial for Brentuximab vedotin (SGN-35) for post transplant Hodgkin Lymphoma [21]
20 April: $9.5 million payment from Genentech to extend collaboration [22]
20 July: initiation of phase I clinical trial of ASG-5ME for treatment of Pancreatic cancer [23]
3 August: expansion of collaboration with Genentech ($12 million upfront payment, up to $900 million in potential fees and milestone payments) [24]
2 September: milestone achievement in collaboration with Agensys for initiation of phase I trial of AGS-16M8F [25] [26]
14 September: entry into collaboration with Genmab [27]
20 October: initiation of phase I clinical trial of ASG-5ME in prostate cancer treatment [28]

2011

6 January: entry into collaboration with Pfizer ($8 million upfront payment, $200+ million in potential milestone payments) [29]
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 [30]
15 March: expansion of collaboration with the Millennium Pharmaceuticals (Takeda Oncology) [31]
22 March: announcement of collaboration with Abbott ($8 million upfront payment, plus potential royalties and milestone payments) [32]
11 April: James Fan, SG manager of clinical programming, commits suicide one day after being indicted for insider trading in Seattle Genetics securities [33] [34]
19 April: expansion of collaboration with Genmab [35]
19 August accelerated FDA approval for Brentuximab vedotin for use in treatment of Hodgkin lymphoma and systemic anaplastic large cell lymphoma (ALCL) [36]
23 August: initiation of phase II trial of ADCETRIS in CD30-positive non-Hodgkin lymphoma [37]
9 September: collaboration with Oxford BioTherapeutics [38]
25 October: initiation of phase II clinical trial of ADCETRIS in CD30-positive non-Lymphoma malignancies [39]

2012

4 June: interim Phase I data from ASG-5ME in prostate cancer [40]
5 July: initiation of global phase III trial of ADCETRIS against CD30-expressing cutaneous T-cell lymphoma [41]
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 [42]
9 October: milestone achievement under collaboration with Genentech by advancements of two anti-body conjugates into phase II trials [43]
17 October: initiation of phase II trial of ADCETRIS in age 60+ Hodgkin Lymphoma patients [44]
23 October: expansion of collaboration with Abbott (upront payment of $25 million, milestone payment up to $220 million) [45]
1 November: initiation of global phase III trial of ADCETRIS in untreated advanced Hodgkin lymphoma patients [46]
26 November: received orphan drug designation for ADCETRIS treatment of mycosis fungoides [47]

2013

1 February: Health Canada approves ADCETRIS for treatment of relapsed refractory Hodgkin lymphoma [48]
6 February: initiation of two phase I trials of SGN-CD19A [49]
25 June: new collaboration with Bayer [50]
15 July: initiation of phase I trial of SGN-CD33A in treatment of Acute Myeloid Leukemia (AML) [51]
15 August: initiation of phase II trial of ADCETRIS for diffuse Large B-cell Lymphoma [52] [53]
21 October: initiation of phase I trial of SGN-LIV1A for patients with LIV-1-positive metastatic breast cancer [54] [55]

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. [56]
8 December: Data of Brentuximab Vedotin in Diffuse Large B-cell Lymphoma presented at the Annual Meeting of the American Society of Hematology ref>Seattle Genetics Presents ADCETRIS® (Brentuximab Vedotin) Data in Diffuse Large B-cell Lymphoma at ASH Annual Meeting Reuters</ref>

2015

12 January: clinical collaboration with Bristol-Myers Squibb to evaluate combination of brentuximab vedotin and nivolumab in hematologic malignancies [57]
18 February: Supplemental Biologics License Application (BLA) for Brentuximab Vedotin in Post-Transplant Hodgkin Lymphoma Patients at High Risk of Relapse [58]
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. [59]
31 December: Adcetris sales increase to $226 million. [60]

2016

For the year: the company was at the bottom of the Annual Top 25 Biotech Companies for the year as judged by staff of Genetic Engineering & Biotechnology News . [61]
28 March: the company announces it will develop 12 more drugs, employing another 100 staff. [60]

Product portfolio and pipeline

Related Research Articles

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Inotuzumab ozogamicin is an antibody-drug conjugate used to treat relapsed or refractory B-cell precursor acute lymphoblastic leukemia (ALL).

Mapatumumab (HGS-ETR1) is an experimental human monoclonal antibody undergoing clinical trials for the treatment of cancer. It targets TRAIL-R1, also known as DR4, which is expressed on the surface of many tumor cell types.

CD33 mammalian protein found in Homo sapiens

CD33 or Siglec-3 is a transmembrane receptor expressed on cells of myeloid lineage. It is usually considered myeloid-specific, but it can also be found on some lymphoid cells.

Lebrikizumab (INN) is a humanized monoclonal antibody and an experimental immunosuppressive drug for the treatment of asthma that cannot be adequately controlled with inhalable glucocorticoids. The drug was created by Tanox under the name TNX-650, and a phase I clinical trial for refractory Hodgkin’s lymphoma had been performed when Genentech acquired Tanox in 2007. It has successfully completed a Phase II clinical trial for the treatment of asthma.

Milatuzumab is an anti-CD74 humanized monoclonal antibody for the treatment of multiple myeloma non-Hodgkin’s lymphoma and chronic lymphocytic leukemia.

Brentuximab vedotin is an antibody-drug conjugate medication used to treat relapsed or refractory Hodgkin lymphoma (HL) and systemic anaplastic large cell lymphoma (ALCL). It selectively targets tumor cells expressing the CD30 antigen, a defining marker of Hodgkin lymphoma and ALCL. The drug is being jointly marketed by Millennium: The Takeda Oncology Company outside the US, and Seattle Genetics in the US.

Monomethyl auristatin E chemical compound

Monomethyl auristatin E (MMAE) is a synthetic antineoplastic agent. Because of its toxicity, it cannot be used as a drug itself; instead, it is linked to a monoclonal antibody (MAB) which directs it to the cancer cells. In International Nonproprietary Names for MMAE-MAB-conjugates, the name vedotin refers to MMAE plus its linking structure to the antibody. It is a potent antimitotic drug derived from peptides occurring in marine shell-less mollusc Dolabella auricularia called dolastatins which show potent activity in preclinical studies, both in vitro and in vivo, against a range of lymphomas, leukemia and solid tumors. These drugs show potency of up to 200 times that of vinblastine, another antimitotic drug used for Hodgkin lymphoma as well as other types of cancer.

Glembatumumab vedotin is an antibody-drug conjugate (ADC) that targets cancer cells expressing transmembrane glycoprotein NMB (GPNMB).

Antibody-drug conjugate

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Vadastuximab talirine or SGN-CD33A is an antibody-drug conjugate or ADC directed to CD33 or Siglec-3 is a transmembrane receptor expressed on cells of myeloid lineage. The trial drug, being developed by Seattle Genetics and currently in clinical trials, is designed for the treatment of acute myeloid leukemia (AML).

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Enfortumab vedotin, sold under the brand name Padcev, is an antibody-drug conjugate designed for the treatment of cancer expressing Nectin-4. Enfortumab refers to the monoclonal antibody part, and vedotin refers to the payload drug (MMAE) and the linker.

Polatuzumab vedotin (INN; brand name Polivy, is an antibody-drug conjugate or ADC designed for the treatment of cancer. The US Food and Drug Administration approved polatuzumab vedotin in June 2019 for treatment of diffuse large B-cell lymphoma when used in combination with bendamustine and rituximab. The drug was developed by Genentech and Roche.

Denintuzumab mafodotin is a humanized monoclonal antibody-drug conjugate designed for the treatment of CD19-positive acute lymphoblastic leukemia and B-cell non-Hodgkin lymphoma. It consists of an anti-CD19 mAb linked to monomethyl auristatin F (MMAF), a cytotoxic agent. This drug was developed by Seattle Genetics.

Loncastuximab tesirine or ADCT-402 is an antibody-drug conjugate (ADC) composed of a humanized antibody targeting the protein CD19, which is expressed in a wide range of B cell hematological tumors. The experimental drug, developed by ADC Therapeutics is being tested in clinical trials for the treatment of B-cell non-Hodgkin lymphoma (NHL) and B-cell acute lymphoblastic leukemia (ALL).

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References

  1. 1 2 3 4 5 6 Wright, Rob (13 February 2018). "Seattle Genetics Legacy Of Partnering". Life Science Leader. Retrieved 22 February 2018.
  2. 1 2 Brentuximab vedotin (SGN35), ADC Review/Journal of Antibody-drug Conjugates
  3. ↑ Brentuximab vedotin (ADCETRIS®) Clinical Trials, ADC Review/Journal of Antibody-drug Conjugates
  4. ↑ https://www.genengnews.com/gen-news-highlights/seattle-genetics-to-acquire-cascadian-therapeutics-for-614m/81255441
  5. ↑ https://uk.reuters.com/article/us-seattle-genetics-stake-merck-co/merck-to-buy-1-bln-stake-in-seattle-genetics-co-develop-cancer-therapy-idUKKBN2651Q7
  6. ↑ Seattle Genetics Corporate Profile Reuters
  7. ↑ Transcripts, SA (10 February 2017). "Seattle Genetics (SGEN) Q4 2016 Results - Earnings Call Transcript". Seeking Alpha. Retrieved 10 January 2018.
  8. ↑ "Seattle Genetics aims to put drug on the front line of battling cancer". The Seattle Times. 17 December 2016. Retrieved 10 January 2018.
  9. ↑ Seattle Genetics Initiates Pivotal Trial of SGN-35 for Hodgkin Lymphoma Corporate Press Release
  10. ↑ Seattle Genetics Initiates Phase II Trial of SGN-35 for Anaplastic Large Cell Lymphoma Corporate Press Release
  11. ↑ Seattle Genetics Initiates Brentuximab Vedotin (SGN-35) Retreatment Clinical Trial Corporate Press Release
  12. ↑ Seattle Genetics Achieves Milestone Under Antibody-Drug Conjugate Collaboration with MedImmune Corporate Press Release
  13. ↑ Annunziata, CM; Kohn, EC; LoRusso, P; Houston, ND; Coleman, RL; Buzoianu, M; Robbie, G; Lechleider, R. "Phase 1, open-label study of MEDI-547 in patients with relapsed or refractory solid tumors". Invest New Drugs. 31: 77–84. doi:10.1007/s10637-012-9801-2. PMC   3553417 . PMID   22370972.
  14. ↑ Seattle Genetics Achieves Milestone Under Antibody-Drug Conjugate Collaboration With Bayer Schering Pharma Corporate Press Release
  15. ↑ Seattle Genetics Announces Discontinuation of Dacetuzumab Phase IIb Diffuse Large B-Cell Lymphoma Clinical Trial Corporate Press Release
  16. ↑ Seattle Genetics Initiates Phase I Clinical Trial of Antibody-Drug Conjugate SGN-75 Corporate Press Release
  17. ↑ Seattle Genetics Announces Termination of Collaboration Agreement with Genentech for Dacetuzumab (SGN-40) Corporate Press Release
  18. ↑ Seattle Genetics Announces Antibody-Drug Conjugate Collaboration with GlaxoSmithKline Corporate Press Release
  19. ↑ 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
  20. ↑ Seattle Genetics Achieves Milestone under Antibody-Drug Conjugate Collaboration with Genentech Corporate Press Release
  21. ↑ 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
  22. ↑ Seattle Genetics to Receive $9.5 Million Payment from Genentech to Extend Antibody-Drug Conjugate Collaboration Corporate Press Release
  23. ↑ Seattle Genetics and Agensys, an Affiliate of Astellas, Announce Initiation of Phase I Clinical Trial of ASG-5ME for Pancreatic Cancer Corporate Press Release
  24. ↑ Seattle Genetics Expands Antibody-Drug Conjugate Collaboration with Genentech Corporate Press Release
  25. ↑ Seattle Genetics Achieves Milestone under Antibody-Drug Conjugate Collaboration with Agensys, an Affiliate of Astellas Corporate Press Release
  26. ↑ 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
  27. ↑ Genmab and Seattle Genetics Enter Into Antibody-Drug Conjugate Research Collaboration Corporate Press Release
  28. ↑ Agensys, an Affiliate of Astellas, and Seattle Genetics Announce Initiation of Phase I Clinical Trial of ASG-5ME for Prostate Cancer Corporate Press Release
  29. ↑ Seattle Genetics Announces Antibody-Drug Conjugate Collaboration with Pfizer Corporate Press Release
  30. ↑ 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
  31. ↑ Seattle Genetics and Millennium Expand Antibody-Drug Conjugate Collaboration Corporate Press Release
  32. ↑ Seattle Genetics Announces Antibody-Drug Conjugate Collaboration with Abbott Corporate Press Release
  33. ↑ Lure of riches leads to suicide in Seattle Genetics stock case | The Seattle Times
  34. ↑
  35. ↑ Genmab and Seattle Genetics Expand Antibody-Drug Conjugate Collaboration Corporate Press Release
  36. ↑ Seattle Genetics Announces FDA Accelerated Approval of ADCETRIS(TM) (Brentuximab Vedotin) for Two Indications Corporate Press Release
  37. ↑ Seattle Genetics Announces Initiation of a Phase II Clinical Trial of ADCETRIS(TM) in CD30-Positive Non-Hodgkin Lymphoma Corporate Press Release
  38. ↑ Seattle Genetics and Oxford BioTherapeutics to Collaborate on Antibody-Drug Conjugates for Cancer Corporate Press Release
  39. ↑ Seattle Genetics Announces Initiation of a Phase II Clinical Trial of ADCETRIS(TM) in CD30-Positive Non-Lymphoma Malignancies Corporate Press Release
  40. ↑ Agensys and Seattle Genetics Announce Interim Phase I Data from ASG-5ME Clinical Trial for Prostate Cancer Astellas Press Release
  41. ↑ Millennium and Seattle Genetics Initiate Global Phase 3 Trial of ADCETRIS™ in Patients with CD30-Expressing Relapsed Cutaneous T-cell Lymphoma Corporate Press Release
  42. ↑ 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
  43. ↑ Seattle Genetics Achieves Milestones as Genentech Advances Two Antibody-Drug Conjugates (ADCs) into Phase II Development Corporate Press Release
  44. ↑ 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
  45. ↑ Seattle Genetics Expands Antibody-Drug Conjugate Collaboration with Abbott Corporate Press Release
  46. ↑ Millennium and Seattle Genetics Initiate Global Phase 3 Clinical Trial of ADCETRIS® in Previously Untreated Advanced Hodgkin Lymphoma Corporate Press Release
  47. ↑ Seattle Genetics Receives FDA Orphan Drug Designation for ADCETRIS® (Brentuximab Vedotin) in Mycosis Fungoides Corporate Press Release
  48. ↑ 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
  49. ↑ Seattle Genetics Initiates Two Phase I Trials of SGN-CD19A Corporate Press Release
  50. ↑ Seattle Genetics Enters Into New Antibody-Drug Conjugate Collaboration with Bayer Corporate Press Release
  51. ↑ Seattle Genetics Initiates Phase 1 Trial of SGN-CD33A in Acute Myeloid Leukemia (AML) Corporate Press Release
  52. ↑ 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
  53. ↑ B-cell lymphoma NCI Dictionary of Cancer Terms; Last Accessed February 18, 2015
  54. ↑ Seattle Genetics Initiates Phase 1 Trial of ADC Candidate, SGN-LIV1A, for Patients with LIV-1-Positive Metastatic Breast Cancer Corporate Press Release
  55. ↑ 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
  56. ↑ Seattle Genetics, Takeda's cancer drug meets main goal in trial Reuters
  57. ↑ Seattle Genetics and Bristol-Myers Squibb Announce Clinical Collaboration to Evaluate Combination of Adcetris® (Brentuximab Vedotin) and Opdivo® (Nivolumab) in Hematologic Malignancies Reuters
  58. ↑ 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
  59. ↑ "Seattle Genetics, Unum Partner on Cancer Immunotherapies in Up-to-$645M Deal - GEN Genetic Engineering & Biotechnology News - Biotech from Bench to Business - GEN".
  60. 1 2 http://www.bizjournals.com/seattle/blog/health-care-inc/2016/03/seattle-genetics-ambitious-plan-for-12-more-drugs.html
  61. ↑ Philippidis, Alex (26 September 2016). "Top 25 Biotech Companies of 2016". Genetic Engineering & Biotechnology News. Mary Ann Liebert. Retrieved 23 December 2019.
  62. ↑ 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
  63. ↑ IMGT/mAb-DB SGN-75 Poiron, C. et al., JOBIM 2010, Paper 13 (2010).
  64. ↑ Enfortumab Vedotin (ASG-22ME, Formerly AGS-22M6E) Clinical trials ADC Review / Journal of Antibody-drug Conjugates; Last accessed February 18, 2015
  65. ↑ Anti-Nectin-4 monoclonal antibody-drug conjugate AGS-22M6E National Cancer Institute (NCI) Drug Dictionary
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