Seagen

Last updated

Seagen Inc.
FormerlySeattle Genetics, Inc.
(1997–2020)
Company type Subsidiary
Nasdaq: SGEN
Industry Biotechnology, pharmaceutical
Founded1997;27 years ago (1997)
Headquarters Bothell, Washington, U.S.
Key people
  • David R. Epstein
  • (Chief Executive Officer)
  • Roger Dansey M.D.
  • (President, Research and Development)
  • Todd E. Simpson
  • (Chief Financial Officer)
Products Brentuximab vedotin and other antibody-drug conjugates
RevenueIncrease2.svg US$1.96 billion (2022)
Increase2.svgUS$−613 million (2022)
Increase2.svgUS$−610 million (2022)
Total assets Decrease2.svgUS$3.67 billion (2022)
Total equity Decrease2.svgUS$2.80 billion (2022)
Number of employees
3,256 (2022)
Parent Pfizer
Website seagen.com
Footnotes /references
[1] [2]

Seagen Inc. (formerly Seattle Genetics, Inc.) is an American 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) [3] 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 [4] 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 company announced it would acquire Cascadian Therapeutics for $614 million. [5]

In September 2020, Merck & Co announced it would purchase $1 billion of Seagen's common stock, with both companies co-developing lead treatment: ladiratuzumab vedotin. [6]

In November 2022, the company announced the appointment of David R. Epstein as Chief Executive Officer and Director. [7]

Pfizer agreed to acquire Seagen in March 2023. [8]

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. [9]

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)

History

Early years

Seattle Genetics was founded in 1997, by Henry Perry Fell, Jr. [10] and Clay Siegall, [11] 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. [12] [13]

2009

19 February: pivotal trial for brentuximab vedotin for Hodgkin lymphoma [14]
18 June: Phase II trial of brentuximab vedotin for anaplastic large cell lymphoma [15]
24 July: initiation of re-treatment clinical trial of brentuximab vedotin [16]
10 August: milestone achievement in collaboration with MedImmune through initiation of Phase I clinical trial of MEDI-547. [17] [18]
8 September: milestone achievement in collaboration with Bayer for the submission of investigational new drug application with the FDA [19]
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 [20]
16 November: initiation of Phase I clinical trial for SGN-75 (INN: vorsetuzumab mafodotin) [21]
11 December: termination of collaboration with Genentech for SGN-40 [22]
21 December: announcement of new collaboration with GlaxoSmithKline ($12 million up front payment, up to $390 million in milestone payments) [23]

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. [11] 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. [11] By 2018, however, the company was confident it could conduct a global commercialization venture. [11]

2010

2 February: initiation of phase I combination clinical trial of brentuximab vedotin (SGN-35) for Hodgkin Lymphoma [24]
3 March: milestone achievement under collaboration with Genentech [25]
8 April: initiation of Phase III trial for brentuximab vedotin (SGN-35) for post transplant Hodgkin Lymphoma [26]
20 April: $9.5 million payment from Genentech to extend collaboration [27]
20 July: initiation of Phase I clinical trial of ASG-5ME for treatment of pancreatic cancer [28]
3 August: expansion of collaboration with Genentech ($12 million upfront payment, up to $900 million in potential fees and milestone payments) [29]
2 September: milestone achievement in collaboration with Agensys for initiation of Phase I trial of AGS-16M8F [30] [31]
14 September: entry into collaboration with Genmab [32]
20 October: initiation of Phase I clinical trial of ASG-5ME in prostate cancer treatment [33]

2011

6 January: entry into collaboration with Pfizer ($8 million upfront payment, $200+ million in potential milestone payments) [34]
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 [35]
15 March: expansion of collaboration with the Millennium Pharmaceuticals (Takeda Oncology) [36]
22 March: announcement of collaboration with Abbott ($8 million upfront payment, plus potential royalties and milestone payments) [37]
11 April: James Fan, SG manager of clinical programming, commits suicide one day after being indicted for insider trading in Seattle Genetics securities [38] [39]
19 April: expansion of collaboration with Genmab [40]
19 August accelerated FDA approval for brentuximab vedotin for use in treatment of Hodgkin lymphoma and systemic anaplastic large cell lymphoma (ALCL) [41]
23 August: initiation of Phase II trial of ADCETRIS in CD30-positive non-Hodgkin lymphoma [42]
9 September: collaboration with Oxford BioTherapeutics [43]
25 October: initiation of Phase II clinical trial of ADCETRIS in CD30-positive non-lymphoma malignancies [44]

2012

4 June: interim Phase I data from ASG-5ME in prostate cancer [45]
5 July: initiation of global Phase III trial of ADCETRIS against CD30-expressing cutaneous T-cell lymphoma [46]
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 [47]
9 October: milestone achievement under collaboration with Genentech by advancements of two antibody conjugates into Phase II trials [48]
17 October: initiation of Phase II trial of ADCETRIS in age 60+ Hodgkin lymphoma patients [49]
23 October: expansion of collaboration with Abbott (upfront payment of $25 million, milestone payment up to $220 million) [50]
1 November: initiation of global Phase III trial of ADCETRIS in untreated advanced Hodgkin lymphoma patients [51]
26 November: received orphan drug designation for ADCETRIS treatment of mycosis fungoides [52]

2013

1 February: Health Canada approves ADCETRIS for treatment of relapsed refractory Hodgkin lymphoma [53]
6 February: initiation of two Phase I trials of SGN-CD19A [54]
25 June: new collaboration with Bayer [55]
15 July: initiation of Phase I trial of SGN-CD33A in treatment of acute myeloid leukemia (AML) [56]
15 August: initiation of Phase II trial of ADCETRIS for diffuse large B-cell lymphoma [57] [58]
21 October: initiation of Phase I trial of SGN-LIV1A for patients with LIV-1-positive metastatic breast cancer [59] [60]

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. [61]
8 December: Data of Brentuximab Vedotin in Diffuse Large B-cell Lymphoma presented at the Annual Meeting of the American Society of Hematology [62]

2015

12 January: clinical collaboration with Bristol-Myers Squibb to evaluate combination of brentuximab vedotin and nivolumab in hematologic malignancies [63]
18 February: Supplemental Biologics License Application (BLA) for Brentuximab Vedotin in Post-Transplant Hodgkin Lymphoma Patients at High Risk of Relapse [64]
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. [65]
31 December: Adcetris sales increase to $226 million. [66]

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 . [67]
28 March: the company announces it will develop 12 more drugs, employing another 100 staff. [66]

2020

The company announced its corporate name change to Seagen Inc. [68]

2022

In July the press reported Merck & Co. was in advanced talks to acquire Seagen Inc. and was aiming to finalize a purchase of the cancer biotech in the next few weeks, according to people familiar with the matter, in a deal that could be worth roughly $40 billion or more. [69] The expected sellout is expected to materialize in the month of August 2022 with some delay due to Merck being set to report its fiscal second-quarter earnings on July 28. [70]

2023

In March 2023, Pfizer agreed to acquire Seagen for a total enterprise value of around $43 billion. The acquisition includes the FDA approved medicines Adcetris for lymphomas, Padcev for bladder cancers, Tivdak for cervical cancer and Tukysa for breast and colorectal cancers as well as Seagen's drug development pipeline. [8]

Pfizer later announced that it would abandon its plans to build a large manufacturing facility in Everett, Washington, which was scheduled to open in 2024. [71] [72]

Product portfolio and pipeline

Related Research Articles

Genentech, Inc. is an American biotechnology corporation headquartered in South San Francisco, California. It became an independent subsidiary of Roche in 2009. Genentech Research and Early Development operates as an independent center within Roche. Historically, the company is regarded as the world's first biotechnology company.

<span class="mw-page-title-main">Anaplastic large-cell lymphoma</span> Medical condition

Anaplastic large-cell lymphoma (ALCL) refers to a group of non-Hodgkin lymphomas in which aberrant T cells proliferate uncontrollably. Considered as a single entity, ALCL is the most common type of peripheral lymphoma and represents ~10% of all peripheral lymphomas in children. The incidence of ALCL is estimated to be 0.25 cases per 100,000 people in the United States of America. There are four distinct types of anaplastic large-cell lymphomas that on microscopic examination share certain key histopathological features and tumor marker proteins. However, the four types have very different clinical presentations, gene abnormalities, prognoses, and/or treatments.

<span class="mw-page-title-main">CD30</span> Mammalian protein found in Homo sapiens

CD30, also known as TNFRSF8, is a cell membrane protein of the tumor necrosis factor receptor family and a tumor marker.

<span class="mw-page-title-main">Targeted therapy</span> Type of therapy

Targeted therapy or molecularly targeted therapy is one of the major modalities of medical treatment (pharmacotherapy) for cancer, others being hormonal therapy and cytotoxic chemotherapy. As a form of molecular medicine, targeted therapy blocks the growth of cancer cells by interfering with specific targeted molecules needed for carcinogenesis and tumor growth, rather than by simply interfering with all rapidly dividing cells. Because most agents for targeted therapy are biopharmaceuticals, the term biologic therapy is sometimes synonymous with targeted therapy when used in the context of cancer therapy. However, the modalities can be combined; antibody-drug conjugates combine biologic and cytotoxic mechanisms into one targeted therapy.

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

Brentuximab vedotin, sold under the brand name Adcetris, is an antibody-drug conjugate medication used to treat relapsed or refractory Hodgkin lymphoma (HL) and systemic anaplastic large cell lymphoma (ALCL), a type of T cell non-Hodgkin lymphoma. 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 Pharmaceuticals outside the US and by Seagen in the US.

<span class="mw-page-title-main">Monomethyl auristatin E</span> 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).

<span class="mw-page-title-main">Antibody–drug conjugate</span> Class of biopharmaceutical drugs

Antibody–drug conjugates or ADCs are a class of biopharmaceutical drugs designed as a targeted therapy for treating cancer. Unlike chemotherapy, ADCs are intended to target and kill tumor cells while sparing healthy cells. As of 2019, some 56 pharmaceutical companies were developing ADCs.

Vorsetuzumab mafodotin (SGN-75) is an antibody-drug conjugate (ADC) directed to the protein CD70 designed for the treatment of cancer. It is a humanized monoclonal antibody, vorsetuzumab, conjugated with noncleavable monomethyl auristatin F (MMAF), a cytotoxic agent.

<span class="mw-page-title-main">Vadastuximab talirine</span> Chemical compound

Vadastuximab talirine is an antibody-drug conjugate (ADC) directed to CD33 (siglec-3) which is a transmembrane receptor expressed on cells of myeloid lineage. The experimental drug, being developed by Seattle Genetics, was in clinical trials for the treatment of acute myeloid leukemia (AML).

<span class="mw-page-title-main">Sutro Biopharma</span> Biotechnology company based in South San Francisco, California

Sutro Biopharma, Inc. is a publicly traded biotechnology company headquartered in South San Francisco, California focused on clinical-stage drug discovery, development and manufacturing. Using a proprietary cell-free protein synthesis platform, Sutro is working on oncology therapeutics using protein engineering and rational design. Founded in 2003 under the name Fundamental Applied Biology, the company name changed to Sutro Biopharma in 2009. William Newell, CEO as of 2024, joined Sutro in January 2009.

ImmunoGen, Inc. was a biotechnology company focused on the development of antibody-drug conjugate (ADC) therapeutics for the treatment of cancer. ImmunoGen was founded in 1981 and was headquartered in Waltham, Massachusetts.

Sofituzumab vedotin is a monoclonal antibody designed for the treatment of ovarian cancer.

Enfortumab vedotin, sold under the brand name Padcev, is an antibody-drug conjugate used for the treatment of urothelial cancer. It is a nectin-4-directed antibody and microtubule inhibitor conjugate. Enfortumab refers to the monoclonal antibody part, and vedotin refers to the payload drug (MMAE) and the linker.

Polatuzumab vedotin, sold under the brand name Polivy, is a CD79b-directed antibody-drug conjugate medication used for the treatment of diffuse large B-cell lymphoma (cancer). It was developed by the Genentech subsidiary of 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.

<span class="mw-page-title-main">Camidanlumab tesirine</span> Antibody-drug conjugate

Camidanlumab tesirine is an antibody-drug conjugate (ADC) composed of a human antibody that binds to the protein CD25, conjugated to a pyrrolobenzodiazepine dimer toxin. The experimental drug, developed by ADC Therapeutics is being tested in clinical trials for the treatment of B-cell Hodgkin's lymphoma (HL) and non-Hodgkin lymphoma (NHL), and for the treatment of B-cell acute lymphoblastic leukemia (ALL) and acute myeloid leukemia (AML).

Tisotumab vedotin, sold under the brand name Tivdak, is an antibody-drug conjugate used to treat cervical cancer. It is a combination of tisotumab, a monoclonal antibody against tissue factor, and monomethyl auristatin E (MMAE), a potent inhibitor of cell division. It is administered by infusion into a vein.

Passive antibody therapy, also called serum therapy, is a subtype of passive immunotherapy that administers antibodies to target and kill pathogens or cancer cells. It is designed to draw support from foreign antibodies that are donated from a person, extracted from animals, or made in the laboratory to elicit an immune response instead of relying on the innate immune system to fight disease. It has a long history from the 18th century for treating infectious diseases and is now a common cancer treatment. The mechanism of actions include: antagonistic and agonistic reaction, complement-dependent cytotoxicity (CDC), and antibody-dependent cellular cytotoxicity (ADCC).

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