Conclusion

As can be seen from this case study of SGEN the development of a drug is a long and costly process and its journey to market is highly unpredictable. Much can happen in the time between the development of a compound in the laboratory and getting it into the clinic. In the case of SGEN its drug development was dependent on the coming together of many different technologies before testing them out in patients. SGEN’s success was largely dependent on its ability to carve out a niche for itself in the field of ADC drugs in the cancer field and persuade other collaborators to join in on its efforts and license its technology.

The company finally managed to get its first drug, Adcetris, on the market in 2011, thirteen years after it started its operations. It took another eight years before the company won approval for another one of its drugs, PADCEV. The company's success with two of its drugs needs to be balanced against its failure with many other drug candidates (table 4). This has meant the company has inevitably accumulated major losses. The company has also continued to operate at a loss because of its continued investment in research and development to expand its pipeline. As is highlighted by the company's development of vadastuximab talirine, which ended in 2017 after five years of effort and it had gone through the costly process of phase III trials, not all of the investment has paid off.

Another important feature to note in the story of Seattle Genetics is how far the scientific platform developed by the company has enabled other companies to develop their drugs. This is a poignant reminder of just how far investments made in research and development by one company can benefit others in the biopharmaceutical arena. The lessons learnt by Seattle Genetics from failures with its early drug candidates to develop Adcetris also highlights just how much the process of drug discovery and development is not a simple linear line of progress. Much can be learnt from the errors along the way. The key is knowing how far a project needs to go before a new direction has to be taken.

Table 4: SGEN's drug candidates and targets showing stage of development

Candidate and target Years of development Development stage
mAb SGN-70 - CD70 2001 - now Phase I
mAb Vorsetuzumab mafodotin (SGN-75) - CD70 2001 - 2014 Phase I
SGN-10 - Lewis-Y (CD174) 2001 - 2002 Phase I
ADC Vandortuzumab vedotin (RG7450, DSTP3086S) - STEAP1 2002 - 2017 Phase I
ADC (DMOT/ RG7600) - mesothelin 2002 - now Phase I
ADC (RG7841/DLYE5953A) - Ly6E 2002 - now Phase I
ADC Lifastuzumab vedotin (RG7599, DNIB0600A) - NaPi2b 2002 - now Phase II
ADC Polatuzumab vedotin (RG7596, DCDS4501A) - CD79b 2002 - now Pivotal/Phase III
ADC RG7636 (DEDN-6526A, DEDN6526A) - ETBR 2002 - now Phase I
ADC SGN-15 - Lewis-Y 2002 - 2005 Phase II
ADC Sofituzumab vedotin (RG7458) - MUC16 2002 - 2015 Phase I
ADEPT therapy SGN-17/19 2002 - now Preclinical
mAb Dacetuzumab (SGN-40, SGN14) - CD40 2002 - 2009 Phase II
mAb SGN-30 - CD30 2002 - 2006 Phase II
Pinatuzumab vedotin RG7593 - CD22 2002 - now Phase II
RG7882 - MUC16 2002 - 2018 Phase I
RG7986 2002 - now Phase I
Undisclosed ADCs 2002 - now Preclinical
ADC - C4.4a 2004 - now Phase I
ADC - CA9 2004 - now Preclinical
ADC - FGFR2 2004 - now Phase I
ADC Glembatumumab vedotin - GPNMB 2004 - now Phase II
ADC - PSMA 2005 - now Phase II
mAb Lintuzumab (SGN-33) - CD33 2005 - 2010 Phase II
ADC - AGS-16 2007 - now Phase I
ADC - CD37 2007 - now Phase I
ADC AGS-16C3F - ENPP3 2007 - now Phase II
ADC ASG5ME - AGS-5 2007 - 2013 Phase I
ADC Denitnuzumab mafodotin (SGN-CD19A, SGN-19A) - CD19 2007 - 2018 Phase II
ADC Enfortumab vedotin/PADCEV (ASG22ME) - Nectin-4 2007 - 2019 Approved
ADC Sirtratumab vedotin (ASG-15ME) - SLTRK6 2007 - now Phase I
Undisclosed ADC 2008 - now Preclinical
ADC - BCMA 2009 - now Phase I
ADC - AGS-16 2009 - now Phase II
ADC Brentuximab vendotin/Adcetris (SGN-35) - CD30 2009 - 2011 Approved
ADC Indusatumab Vedotin TAK-264 (MLN0264) - GCC (guanylyl cyclase C) 2009 - 2016 Phase II
3 undisclosed ADCs 2010 - now Phase I
ADC - EGFR 2010 - now Phase II
ADC 5T4-MMAF - 5T4 2010 - now Phase I
ADC - AXL 2011 - now Phase I
ADC - CD74 2011 - now Phase I
ADC SGN48A - CD48A 2011 - now Phase I
ADC Tisotumab vedotin - Tissue factor 2011 - now Phase II
Undisclosed ADCs 2011 - now Preclinical
ADC Ladiratuzumab vedotin (SGN-LIV1A) - LIV-1 2012 - now Phase II
ADC Vadastuximab talirine (CD33A) - CD33 2012 - 2017 Pivotal/Phase III
T cell therapy ACTR087 - SEA-BCMA 2015 - now Phase I
2-fluorofucose SGN-2FF 2016 - now Preclinical
ADC (SGN-CD123A) - CD123 2016 - 2018 Phase I
Tucatinib - HER2 2018 - now Phase II/ Pivotal

mAb SGN-70 - CD70

2001 - now

mAb Vorsetuzumab mafodotin (SGN-75) - CD70

2001 - 2014

SGN-10

2001 - 2002

ADC Vandortuzumab vedotin (RG7450, DSTP3086S)

2002 - 2017

ADC (DMOT/ RG7600)

2002 - now

ADC (RG7841/DLYE5953A)

2002 - now

ADC Lifastuzumab vedotin (RG7599, DNIB0600A)

2002 - now

ADC Polatuzumab vedotin (RG7596, DCDS4501A)

2002 - now

ADC RG7636 (DEDN-6526A, DEDN6526A)

2002 - now

ADC SGN-15 - Lewis-Y

2002 - 2005

ADC Sofituzumab vedotin (RG7458)

2002 - 2015

ADEPT therapy SGN-17/19

2002 - now

mAb Dacetuzumab (SGN-40, SGN14)

2002 - 2009

mAb SGN-30 - CD30

2002 - 2006

Pinatuzumab vedotin RG7593

2002 - now

RG7882

2002 - 2018

RG7986

2002 - now

Undisclosed ADCs

2002 - now

ADC

2004 - now

ADC

2004 - now

ADC

2004 - now

ADC Glembatumumab vedotin

2004 - now

ADC

2005 - now

mAb Lintuzumab (SGN-33) - CD33

2005 - 2010

ADC

2007 - now

ADC

2007 - now

ADC AGS-16C3F

2007 - now

ADC ASG5ME

2007 - 2013

ADC Denitnuzumab mafodotin (SGN-CD19A, SGN-19A) - CD19

2007 - 2018

ADC Enfortumab vedotin/PADCEV (ASG22ME)

2007 - 2019

ADC Sirtratumab vedotin (ASG-15ME)

2007 - now

Undisclosed ADC

2008 - now

ADC

2009 - now

ADC

2009 - now

ADC Brentuximab vendotin/Adcetris (SGN-35)

2009 - 2011

ADC Indusatumab Vedotin TAK-264 (MLN0264)

2009 - 2016

3 undisclosed ADCs

2010 - now

ADC

2010 - now

ADC 5T4-MMAF

2010 - now

ADC

2011 - now

ADC

2011 - now

ADC SGN48A

2011 - now

ADC Tisotumab vedotin

2011 - now

Undisclosed ADCs

2011 - now

ADC Ladiratuzumab vedotin (SGN-LIV1A) - LIV-1

2012 - now

ADC Vadastuximab talirine (CD33A) - CD33

2012 - 2017

T cell therapy ACTR087

2015 - now

2-fluorofucose SGN-2FF

2016 - now

ADC (SGN-CD123A) - CD123

2016 - 2018

Tucatinib - HER2

2018 - now

Approved Discontinued Ongoing

Source: Seattle Genetic's Annual Reports.

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