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Perspective

Antibody-drug conjugates: Intellectual property considerations

Pages 989-1009 | Received 28 May 2015, Accepted 05 Aug 2015, Published online: 18 Sep 2015

References

  • Beck A, Reichert JM. Antibody-drug conjugates: present and future. MAbs 2014; 6(1):15-17; PMID:24423577
  • Rostami S, Qazi I, Sikorski R. The Clinical Landscape of Antibody-drug Conjugates. ADC Review 2014; August 1, 2014.
  • Rohrer T. Consideration for the safe and effective manufacturing of antibody drug conjugates. Chemistry Today 2012; 30(5):76-79.
  • Wu WJ. Regulatory Perspective on Challenges in ADC Development (Keynote presentation) PepTalk 2015; January 19–23; 2015, San Diego, CA.
  • Lash A. Antibody-drug conjugates: the next generation of moving parts. START-UP 2001; 27 Dec 2011.
  • DiMasi JA, Grabowski HG. The cost of biopharmaceutical R&D: is biotech different? Manag Decis Econ 2007; 28:469-479.
  • Mullard A. New drugs cost US$2.6 billion to develop. Nature Reviews Drug Discovery 2014; 13(12):877-877
  • Grabowski H, Cockburn I, Long G. The market for follow-on biologics: how will it evolve? Health Affairs (Project Hope) 2006; 25(5):1291-301; PMID:16966725
  • Lash A. Antibody-drug conjugates: the next generation of moving parts. START-UP 2001; 27 Dec 2011.
  • Stewart M, Kent L, Smith A, Bassinder E. The special inventive step standard for antibodies. epi information 2011; 2/2011:72-76.
  • Bander NH. Antibody-drug conjugate target selection: critical factors. Methods Mol Biol 2013; 1045:29-40; PMID:23913139
  • Erster O, Thomas JM, Hamzah J, Jabaiah AM, Getz JA, Schoep TD, Daugherty PS. Site-specific targeting of antibody activity in vivo mediated by disease-associated proteases. J Control Release 2012; 161(3):804-12
  • List T, Neri D. Biodistribution studies with tumor-targeting bispecific antibodies reveal selective accumulation at the tumor site. mAbs 2012; 4(6):775-83; PMID:23032949
  • Rostami S, Qazi I, Sikorski R. The clinical landscape of antibody-drug conjugates. ADCReview 2014; August 1, 2014.
  • Lash A. Antibody-drug conjugates: the next generation of moving parts. START-UP 2001; 27 Dec 2011.
  • ImmunoGen press releases of October 11, 2013 (http://investor.immunogen.com/releasedetail.cfm?ReleaseID=796395); December 20, 2011 (http://investor.immunogen.com/releasedetail.cfm?ReleaseID=634459); March 23, 2015 (http://investor.immunogen.com/releasedetail.cfm?ReleaseID=902766) and December 26, 2006 (http://www.biospace.com/News/immunogen-inc-announces-that-sanofi-aventis-has/41104).
  • Endo N, Takeda Y, Umemoto N, Kishida K, Watanabe K, Saito M, Hara T. Nature of linkage and mode of action of methotrexate conjugated with antitumor antibodies: implications for future preparation of conjugates. Cancer Res 1988; 48(12):3330-5; Retrieved from http://cancerres.aacrjournals.org/content/48/12/3330.short; PMID:3259466
  • Starling JJ, Maciak RS, Hinson NA, Nichols CL, Briggs SL, Laguzza BC. In vivo efficacy of monoclonal antibody-drug conjugates of three different subisotypes which bind the human tumor-associated antigen defined by the KS1/4 monoclonal antibody. Cancer Immunol Immunother 1989; 28(3):171-8; Retrieved from http://www.ncbi.nlm.nih.gov/pubmed/2784353; PMID:2784353
  • Teicher BA, Chari RVJ. Antibody conjugate therapeutics: challenges and potential. Clin Cancer Res 2011; 17(20):6389-97; PMID:22003066; http://dx.doi.org/10.1158/1078-0432.CCR-11-1417
  • Rostami S, Qazi I, Sikorski R. The Clinical Landscape of Antibody-drug Conjugates. ADCReview 2014 August 1; 2014.
  • Decision KSR Int'l Co. v. Teleflex, Inc., 550 US 398, US Supreme Court 2007.
  • Stewart M, Kent L, Smith A, Bassinder E. The special inventive step standard for antibodies. epi information 2011; 2/2011; 72-76.
  • Wooge C, Swamy J. Next-Gen ADCs: collaborating to improve supply chains for development and technology transfer with novel technology platforms. Contract Pharma 2014; Nov/Dec 2014; 16(9):50.
  • Storz U. Rituximab: how approval history is reflected by a corresponding patent filing strategy. MAbs 2014; 6(4):820-37; PMID:24866199; http://dx.doi.org/10.4161/mabs.29105
  • Prescribing information for Kadcyla® (Ado-trastuzumab emtasine); http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/125427lbl.pdf
  • Chari RV, Martell BA, Gross JL, Cook SB, Shah SA, Blättler WA, Goldmacher VS. Immunoconjugates containing novel maytansinoids: promising anticancer drugs. Cancer Res 1992; 52(1):127-31; Retrieved from http://www.ncbi.nlm.nih.gov/pubmed/1727373; PMID:1727373
  • Minami T, Kijima T, Kohmo S, Arase H, Otani Y, Nagatomo I, Kumanogoh A. Overcoming chemoresistance of small-cell lung cancer through stepwise HER2-targeted antibody-dependent cell-mediated cytotoxicity and VEGF-targeted antiangiogenesis. Sci Rep 2013; 3:2669; PMID:24036898; http://dx.doi.org/10.1038/srep02669
  • Synthon press release of April 02, 2014; http://www.synthon.com/en/Corporate/News/PressReleases/Synthons-Anti-HER2-ADC-Frontrunner-SYD985-Outperforms-Only-Available-HER2-targeting-ADC.aspx
  • https://clinicaltrials.gov/ct2/show/NCT02277717
  • Axup JY, Bajjuri KM, Ritland M, Hutchins BM, Kim CH, Kazane SA, Schultz PG. Synthesis of site-specific antibody-drug conjugates using unnatural amino acids. Proc Natl Acad Sci USA 2012; 109(40):16101-6; PMID:22988081; http://dx.doi.org/10.1073/pnas.1211023109
  • International Patent Application WO2014089127A1, assigned to Merrimack. 12 June 2014; Available at http://worldwide.espacenet.com/publicationDetails/originalDocument?CC=WO&NR=2014089127A1&KC=A1&FT=D&ND=&date=20140612&DB=&&locale=en_EP
  • Hu S. Homogeneous ADCs of Herceptin-MMAE with Non-cleavable Linker is more Potent than that with a Cleavable Linker. Oral presentation at ICA 7th Annual Internatl Congress on Antibodies; Nanjing, CN; April 27, 2015
  • Allen L, Mi Y, Abbas M, Richter W, Hu S. Homogeneous ADCs bearing two different payloads show strong synergy in tumor killing. Poster presented at World ADC Summit; 2014; San Diego, CA. Available at http://www.eposters.net/redirect/ ?ID=2456&UID=0&Link=http://www.eposters.net/pdfs/homogeneous-adcs-bearing-two-different-payloads-show-strong-synergy-in-tumor-killing.pdf
  • Grawunder U. Sortase-mediated generation of site-specifically conjugated next-generation ADCs for treatment of cancer. Oral Presentation at PEGS conference, Boston, USA, on May 06 2015; 2015.
  • Cohen R, Vugts DJ, Visser GWM, Stigter-van Walsum M, Bolijn M, Spiga M, van Dongen GAMS. Development of novel ADCs: conjugation of tubulysin analogues to trastuzumab monitored by dual radiolabeling. Cancer Res 2014; 74(20):5700-10; PMID:25145670; http://dx.doi.org/10.1158/0008-5472.CAN-14-1141

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