Antibodies: Timeline of key events

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Daclizumab was approved by the FDA for the preventition of acute rejection of kidney transplants. The monoclonal antibody was developed by Protein Design Labs using a humanising method devised by Cary Queen and marketed together with F. Hoffmann-La Roche. 1997-12-01T00:00:00+0000The drug is a monoclonal antibody that targets cancer cells that overproduce the HER2/neu oncoprotein1998-01-01T00:00:00+0000Remicade (infliximab) is approved for the treatment of Crohn's disease. Soon after Remicade wins approval for other autoimmune and inflammatory conditions including rheumatoid arthritis and ulcerative colitis. The drug, a monoclonal antibody against TNF alpha, a powerful promoter of inflammation, was developed in 1989 by Jan Vilcek and Jumning Le and developed in collaboration with Centocor, Marc Feldmann and Maini1998-08-01T00:00:00+0000Launched by the biotechnology company Medarex in collaboration with Jim Allison. 2000-01-01T00:00:00+0000Michael Smith shared the 1993 Nobel Prize for Chemistry for a technique that enables researchers to introduce specific mutations into genes and, thus, to the proteins that they encode. He developed the method, known as site-directed mutagenesis, in the 1970s, in collaboration with Fred Sanger and Clyde A Hutchinson III. The advantage of the technique was that it allowed comparisons to be made of different protein molecules and provide a means to deliberately alter a specific gene thereby making it possible to modify the characteristics of an organism. His work opened up a new chapter for studying and treating genetic diseases. Site-directed mutagenesis is a pivotal tool today in genetic and protein research and engineering and at the forefront of the development of monoclonal antibody drugs. 2000-10-04T00:00:00+0000Milstein was an Argentinian biochemist. Together with Georges Kohler, Milstein developed the first unlimited supply of long-lasting monoclonal antibodies. Their technique now underpins the development and application of many diagnostics and therapeutics. Kohler and Milstein devised the method as part of their search for a tool to investigate how the immune system can make so many different kinds antibodies, each able to bind to a highly specific receptor on foreign substances that invade the body. 2002-03-24T00:00:00+0000Adalimumab (Humira) approved by the FDA for the treatment of rheumatoid arthritis. The drug was developed and marketed by a collaboration between Cambridge Antibogy Technology, BASF Bioresearch Corporation and Abbott Laboratories.2002-12-31T00:00:00+0000The diagnostic, called NeutroSpectT, uses a monoclonal antibody, SSEA1, discovered at the Wistar Institute and developed by Palatin Technologies.2004-04-05T00:00:00+0000The two companies agreed to share the costs and responsibilities of research and product development up to the completion of a Phase 2 clinical study in each party's territory.2005-05-01T00:00:00+0000Schoemaker was a Dutch biochemist who was co-founder and first Chief Executive Officer of Centocor, an American biotechnology company that pioneered the commercialisation of monoclonal antibody diagnostics and therapeutics. After Centocor was sold to Johnson & Johnson for $5.2 billion in 1999, Schoemaker founded Neuronyx to develop cellular therapies. One of the treatments pioneered by Neuronyx was the use of stem cells from bone marrow to help regenerate heart tissue damaged by heart attacks. 2006-01-01T00:00:00+0000Panitumumab (Vectibix) was approved by the FDA for the treatment of patients with EGFR-expressing metatastic colorectal cancer. The drug is a fully human monoclonal antibody created with transgenic mice. It was developed by Agensys with Amgen. 2006-09-27T00:00:00+0000Drug, MSX-1106, to be assessed for malignant melanoma, renal cell cancer, castrate-resistant prostate cancer and non-small cell lung carcinoma2008-11-24T00:00:00+0000Klinman was an American immunologist who developed the splenic focus assay, a tool that allowed analysis of antibody production derived from single clones of B cells. He used the tool to analyse immune tolerance and immune responses to influenza. In additon he invented the splenic fragment system, a technique that helped generate some of earliest monoclonal antibodies against viral antigens and cancer.2010-05-04T00:00:00+0000The drug was approved for the treatment of unresectable or metastatic melanoma. The drug uses a monoclonal that blocks CTLA-4 so as to activate an immune response against the cancer.2011-03-25T00:00:00+0000Edelman was an American biologist renowned for his research on antibodies, the body's defense against harmful foreign substances like viruses and bacteria. His research helped determine the chemical structure of antibodies in the early 1960s. It showed that antibodies were made up of two light and heavy chains linked together by disulfide bonds. The breakthrough immediately galvanised feverish activity in all fields of immunological science, paving the way to the development of antibodies for both diagnostics and therapy. Edelman was awarded the Nobel Prize for Medicine in 1972 for his work. 2014-05-17T00:00:00+0000The drug was developed by scientists at Medarex2014-09-01T00:00:00+0000The drug, a monoclonal antibody, was approved by the FDA for the treatment of patients with melanoma. 2014-12-22T00:00:00+0000The drugs use a monoclonal antibody to block a protein known as PD-1, which functions as an immune checkpoint, being responsible for preventing the activation of T-cells. Promising results were presented to American Society for Clinical Conference from trials directed towards treating lung and skin cancer. 2015-06-05T00:00:00+0000The drug was developed by Genetech/Roche2016-05-01T00:00:00+0000J. Sevigny et al, 'The antibody aducanumab reduces A-beta plaques in Alzheimer’s disease', 'Nature', 37 (2016), 50-56.2016-09-01T00:00:00+0000
Date Event People Places Sciences
Dec 1997First humanised monoclonal antibody approved for marketQueenProtein Design Labs, RocheMonoclonal antibodies, Recombinant DNA
1998FDA approved Trastuzumab (Herceptin) for the treatment of metastatic breast cancer   Monoclonal antibodies, Oncology
Aug 1998FDA and European regulatory authorities approved the first monoclonal antibody drug for an autoimmune diseaseVilcek, Le, Feldmann, MainiNew York University, Centocor, Kennedy Institute of RheumatologyMonoclonal antibodies
2000First clinical trials launched to test first immune checkpoint inhibitor drug containing a monoclonal antibody against CTLA-4 (ipilimumab, Yervoy®)AllisonMedarex, University of California BerkleyImmune checkpoint inhibitors, Immunology, Cancer immunotherapy, Oncology, Monoclonal antibodies
4 Oct 2000Michael Smith diedSmithUniversity of British ColumbiaGene editing, Genetics, Monoclonal antibodies
Mar 2002Cesar Milstein diedMilsteinLaboratory of Molecular BiologyAntibodies, Monoclonal antibodies, Immunology
Dec 2002First monoclonal antibody made using phage display approved for market CAT, BASF, AbbottMonoclonal antibodies, Phage display
Apr 2004US FDA approved new imaging agent for detecting difficult to diagnose cases of appendicitis Wistar Institute, Palatin TechnologiesMonoclonal antibodies
May 2005Medarex and Ono Pharmaceuticals entered research alliance to develop a fully human anti-PD-1 antibody for the treatment of cancer Medarex, Ono PharmaceuticalImmune checkpoint inhibitors, Immunotherapy, Monoclonal antibodies
1 Jan 2006Hubert Schoemaker died in Philadelphia, USASchoemakerCentocorMonoclonal antibodies, Stem cells
Sep 2006First fully human monoclonal antibody drug approved Agensys, AmgenMonoclonal antibodies, transgenic
24 Nov 2008First anti-PD-1 antibody entered phase 1 clinical trial for cancer Medarex, Ono PharmaceuticalImmune checkpoint inhibitors, Immunotherapy, Monoclonal antibodies
4 May 2010Norman Klinman died in San Diego, California, USAKlinmanWistar Institute, University of PennsylvaniaAntibodies, Monoclonal antibodies, Immunology
25 Mar 2011First immune checkpoint inhibitor drug targeting CTLA4 (ipilimumab, Yervoy®), approved by the FDAAllisonMedarex, University of California BerkleyImmune checkpoint inhibitors, Cancer immunotherapy, Oncology, Monoclonal antibodies
17 May 2014Gerald M Edelman diedEdelmanRockefeller UniversityAntibodies, Immunology
Sep 2014FDA approved nivolumab (Opdivo®), an immune checkpoint inhibitor targeting PD1, for treating melanoma  Immune checkpoint inhibitors, Immuotherapy, Oncology, Monoclonal antibodies
22 Dec 2014First immune checkpoint inhibitor drug targeting PD-1 (nivolumab, Opdivo®) approved in US Honko, Freeman, LonbergMedarex, Bristol-Myers Squibb, Ono PharmaceuticalImmune checkpoint inhibitors, Cancer immunotherapy, Oncology, Monoclonal antibodies
5 Jun 2015Two immunotherapy drugs reported to stop cancer cells avoiding destruction by immune system Allison Cancer immunotherapy, Oncology, Monoclonal antibodies
1 May 2016FDA approved atezolizumab (Tecentriq®), an immune checkpoint inhibitor targeted at PD1, for the treatment of urothelial carcinoma, the most common form of bladder cancer Genentech, RocheImmune checkpoint inhibitor, Immuotherapy, Oncology, Monoclonal antibodies
1 Sep 2016Monoclonal antibody drug for Alzheimer's Disease shown to be promising in phase II clinical trialsSevigny, Chiao, Bussiere, WeinrebBiogen, Neuimmune, Butler Hospital, University of ZurchMonoclonal antibodies, Neuroscience

Dec 1997

First humanised monoclonal antibody approved for market

1998

FDA approved Trastuzumab (Herceptin) for the treatment of metastatic breast cancer

Aug 1998

FDA and European regulatory authorities approved the first monoclonal antibody drug for an autoimmune disease

2000

First clinical trials launched to test first immune checkpoint inhibitor drug containing a monoclonal antibody against CTLA-4 (ipilimumab, Yervoy®)

4 Oct 2000

Michael Smith died

Mar 2002

Cesar Milstein died

Dec 2002

First monoclonal antibody made using phage display approved for market

Apr 2004

US FDA approved new imaging agent for detecting difficult to diagnose cases of appendicitis

May 2005

Medarex and Ono Pharmaceuticals entered research alliance to develop a fully human anti-PD-1 antibody for the treatment of cancer

1 Jan 2006

Hubert Schoemaker died in Philadelphia, USA

Sep 2006

First fully human monoclonal antibody drug approved

24 Nov 2008

First anti-PD-1 antibody entered phase 1 clinical trial for cancer

4 May 2010

Norman Klinman died in San Diego, California, USA

25 Mar 2011

First immune checkpoint inhibitor drug targeting CTLA4 (ipilimumab, Yervoy®), approved by the FDA

17 May 2014

Gerald M Edelman died

Sep 2014

FDA approved nivolumab (Opdivo®), an immune checkpoint inhibitor targeting PD1, for treating melanoma

22 Dec 2014

First immune checkpoint inhibitor drug targeting PD-1 (nivolumab, Opdivo®) approved in US

5 Jun 2015

Two immunotherapy drugs reported to stop cancer cells avoiding destruction by immune system

1 May 2016

FDA approved atezolizumab (Tecentriq®), an immune checkpoint inhibitor targeted at PD1, for the treatment of urothelial carcinoma, the most common form of bladder cancer

1 Sep 2016

Monoclonal antibody drug for Alzheimer's Disease shown to be promising in phase II clinical trials