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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