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词条 The Immune Response Corporation
释义

  1. Overview

  2. Products

      Cancer Immunotherapy    HIV Immunotherapeutic  

  3. Novartis Buys Dendreon New Jersey Plant

  4. References

{{short description|Immunotherapeutic company founded by Jonas Salk and Kevin Kimberlin}}The Immune Response Corporation (IRC) pioneered immunotherapeutic products. Founded by Jonas Salk and Kevin Kimberlin, and based in Carlsbad, California. When Kimberlin “asked Salk to become lead scientific advisor for a new biotech company specializing in ‘anti-idiotypes,’ a novel vaccine technology,”[1] Salk called the proposal “liberating.”[2]

Overview

Francis Crick once said about Salk, “Few have made one discovery that has benefited humanity so greatly. Jonas was a man who, right to his last day, was actively in pursuit of another.”[3] That pursuit was The Immune Response Corporation.

The management team included CEO Jim Glavin, former CEO of Genetic Systems (acquired by Bristol Myers) and Chief Scientific Officer, Dennis Carlo, a former Vice President of R&D at Hybritech.[4] Joe O'Neill became CEO in 2005,[5] recruited for his work as the chief architect of the President's Emergency Plan for AIDS Relief, known as PEPFAR.[6][7][8] Corporate partners supporting IRC included The Rorer Group, Rhone Poulenc, The Pasteur Institute, Institute Merieux, NovaRx, Agouron Pharmaceuticals, Bayer, and Pfizer.

Products

Cancer Immunotherapy

The anti-idiotype program had a significant impact on the ultimate acceptance of immunotherapy. It was based on research by Belgian biologist, Jacques Urbain[9], whom Kimberlin retained for the firm’s Science Advisory Board, and who reported to Jonas Salk. Urbain conducted idiotypic research showing a “dramatic enhancement of an antiviral immune response by dendritic cells,” thus demonstrating the principle of a dendritic cell-enhanced immune response by means of anti-idiotype antibodies.[10] He then created an anti-idiotype tumor vaccine against lymphocytes “not normally recognized” by the immune system.[11] The Immune Response Corporation filed a patent on this invention entitled: “Idiotypic Vaccination Against B-Cell Lymphoma” in May 1990.[12][13] The IRC described the vaccination treatment under development as utilizing antigen-presenting dendritic cells to stimulate responses to tumor antigens. The dendritic cells are exposed to tumor antigens in vitro and then reintroduced in vivo to stimulate anti-tumor immunity. Preclinical studies published in 1994 in the European Journal of Immunology demonstrated that 8 out of 10 of the treated rats survived post-treatment, whereas the 10 control rats died.[14] Nature Medicine later reported on  an independent group of scientists at Stanford University who published results of a Phase I clinical trial using this technology to treat patients for B-cell lymphoma.[15]

In April 1997, IRC licensed this invention to a startup that became known as Dendreon,[16] for founders stock, $500,000 and royalties. Its major investor was Paul Allen[17] (Vulcan Ventures owned 22% of the company by the time it went public). Allen had been diagnosed with non-Hodgkins disease, often a precursor to B-cell lymphoma, the subject of the invention. After incubation and pre-clinical validation by IRC, the product was tested and found safe and effective in humans.[18] Based on positive clinical results, this product, Sipuleucel-T, more commonly known as Provenge, became the first therapeutic cancer vaccine.[19]

Rooted in IRC's earliest work, Scientific American and CNN[20] were among the first to identify this is as landmark vaccine and a milestone.

Sipuleucel-T was recommended in 2015 by the National Comprehensive Cancer Network as a first-line treatment for patients with metastatic Castration Resistant Prostate Cancer.[21] According to its manufacturer, the Sanpower Group, more than 30,000 men had been prescribed Sipuleucel-T as of 2017.[22]

The process and facility that produced IRC’s dendritic cell invention was also the key to the approval of Kymriah, the first CAR-T immunotherapy (chimeric antibody receptor T-Cell).[23] In order to produce clinical and commercial quantities and obtain FDA-approval, its producer, Novartis, required a complex manufacturing infrastructure capable of delivering an immunotherapeutic of consistent quality.[24] “Luckily, one biotech, Dendreon, solved this problem with its prostate cancer treatment,” as stated in Forbes Magazine.[25] The team running the manufacturing facility were experts at producing and distributing the only commercially available cancer immunotherapy, so Novartis purchased the process and the FDA-approved facility and hired 100 people who were making the prostate cancer immunotherapy in order to produce clinical and commercial amounts of Kymirah.[23][26] Kymriah was approved by the Food and Drug Administration (FDA) on August 13, 2017, and it was the world’s first gene therapy to reach the market.[27] Its approval was recognized by FDA Commissioner Scott Gottlieb who remarked: “Today marks another milestone in the development of a whole new scientific paradigm of the treatment of serious diseases…We’re entering a new frontier in medical innovation with the ability to reprogram a patient’s own cells to attack a deadly cancer.”[28]

HIV Immunotherapeutic

The company’s AIDS immunotherapy was based a hypothesis of Jonas Salk's, published in Nature, “Prospects for the Control of AIDS through Immunization of Seropositive Individuals.”[29]

Designed to help HIV-infected patients mount a more vigorous immune response, it was rooted in the principle of non-infectious viral immunization pioneered by Dr. Salk in his polio vaccine. Other companies at the time were testing HIV therapies but none “moved more aggressively toward large-scale human trials” according to an article in The New York Times.[30] For example, IRC applied for trial approval, and within 35 days, in November, 1987, sponsored the first HIV vaccine trial on humans “under a 1987 law that allows California researchers to test new AIDS therapies without seeking federal approval.”[31]  The subsequent Phase III trial, Study 806, was the first large-scale trial to study an immune-based therapy.[32] Enrolling 2,527 patients, it was a random, placebo-controlled trial to assess the HIV immune therapy in combination with antiviral drugs. The end point was slowing the progression to AIDS or death for patients having CD4 T-cells between 300 and 549 cells/mm.[33] Since interpretation of the findings during the study proved problematic, 806 was stopped before completion.  Due to funding constraints, the Company abandoned the project and liquidated its assets in 2008.[34]

Novartis Buys Dendreon New Jersey Plant

Bruce Walker commented on the outcome of Study 806. Walker was the director of the Harvard Medical School division of AIDS at Massachusetts General Hospital, the largest teaching hospital for Harvard Medical School. He wrote, “The study was stopped prematurely due to the decrease in AIDS-related illness resulting from the introduction of more effective antiviral drug combinations. In addition, the study was not well controlled. Participants differed in terms of the antiviral medications during the course of that study, making interpretation of the findings problematic.”[35] Nonetheless, Walker found in the study “the first clear demonstration of the potential reconstitution of the immune response in chronic HIV infection…This is the first proof of the principle that therapeutic vaccination can help people with chronic HIV infection mount a strong CD4 helper cell response.”[36]

References

1. ^Nobile, Philip. “Jonas Salk’s Quest for an AIDS Vaccine.” Village Voice.  October 23, 1990 Vol XXXV No. 43.
2. ^{{Citation|last=Charlotte|first=Jacobs|title=Jonas Salk : a life|others=Ward, Pam|isbn=978-1504663083|oclc=919967060}}
3. ^Sherrow, Victoria.  “Jonas Salk, Beyond the Microscope.” Revised Edition. Chelsea House Publisher 2008. P 112.
4. ^The Immune Response Corporation, Registration Statement filed with The Securities Exchange Commission. October 28, 1996. Pg 35.
5. ^{{Cite news|url=https://www.businesswire.com/news/home/20051101005658/en/Joseph-F.-ONeill-M.D.-Director-Office-National|title=Joseph F. O'Neill, M.D., Former Director of the Office of National AIDS Policy, Joins The Immune Response Corporation as CEO and President|access-date=2018-10-08|language=en}}
6. ^{{Cite web|url=https://foreignpolicy.com/2013/02/14/what-george-w-bush-did-right/|title=What George W. Bush Did Right|last=Caryl|first=Christian|date=February 14, 2013|website=Foreign Policy|language=en|archive-url=|archive-date=|dead-url=|access-date=}}
7. ^{{Cite news|url=http://news.bbc.co.uk/2/hi/africa/7831460.stm|title=Has Bush Been Africa's Best Friend?|last=Plaut|first=Martin|date=January 16, 2009|work=BBC News|access-date=|language=en-GB}}
8. ^{{Cite news|url=http://www.nbcnews.com/id/28605888/ns/world_news-africa/t/aids-battle-burnishes-bushs-legacy-africa/#.W7t2yBNKj1I|title=AIDS Battle Burnishes Bush's Legacy in Africa|last=|first=|date=2009-01-11|work=NBC News|access-date=|language=en}}
9. ^{{Citation|last=|first=|title=Idiotypic Vaccination Against B Cell Lymphoma|url=https://patentscope.wipo.int/search/en/detail.jsf?docId=WO1991013632&redirectedID=true|volume=|pages=|patent-number=|issue-date=1991/09/20|access-date=|inventor-last=Bohlen|inventor2-last=Urbain|inventor3-last=Thielemans|inventor-first=Heribert|inventor2-first=Jacques|inventor3-first=Kristiaan}}. https://patentscope.wipo.int/search/en/detail.jsf?docId=WO1991013632&redirectedID=true
10. ^{{Cite journal|last=Francotte|first=M.|last2=Urbain|first2=J.|date=1985-12-01|title=Enhancement of antibody response by mouse dendritic cells pulsed with tobacco mosaic virus or with rabbit antiidiotypic antibodies raised against a private rabbit idiotype|journal=Proceedings of the National Academy of Sciences|language=en|volume=82|issue=23|pages=8149–8152|doi=10.1073/pnas.82.23.8149|issn=0027-8424|pmc=391460|pmid=3877936}}
11. ^Ellis, Ronald W. "Vaccines: New Approaches to Immunological Problems". Pg 336.
12. ^{{Citation|last=|first=|title=Idiotypic Vaccination Against B Cell Lymphoma|url=https://patentscope.wipo.int/search/en/detail.jsf?docId=WO1991013632&redirectedID=true|volume=|pages=|patent-number=WO/1991/013632|issue-date=1991/09/20|access-date=2018-10-08|inventor-last=Bohlen|inventor2-last=Urbain|inventor3-last=Thielemans|inventor-first=Heribert|inventor2-first=Jacques|inventor3-first=Kristiaan}}. https://patentscope.wipo.int/search/en/detail.jsf?docId=WO1991013632&redirectedID=true
13. ^The Securities and Exchange Commission, Registration Statement for The Immune Response Corporation. 10.28.96. Pgs 29-31. https://www.nasdaq.com/markets/ipos/filing.ashx?filingid=465620
14. ^The Securities and Exchange Commission. Registration Statement for The Immune Response Corporation. 10.28.96. Pg 3029-31.
15. ^Nature Medicine. Volume 2. 1996. Pg 52–58. https://www.nature.com/articles/nm0196-52   
16. ^{{Cite journal|date=2006|title=Sipuleucel-T: APC 8015, APC-8015, prostate cancer vaccine--Dendreon|journal=Drugs in R&D|volume=7|issue=3|pages=197–201|issn=1174-5886|pmid=16752945|doi=10.2165/00126839-200607030-00006}}
17. ^{{Cite web|url=http://community.seattletimes.nwsource.com/archive/?date=19991022&slug=2990525|title=Business {{!}} Vulcan Backs Biotech Firm Dendreon With $10 Million {{!}} Seattle Times Newspaper|website=community.seattletimes.nwsource.com|access-date=2018-10-18}}
18. ^{{Cite web|url=https://www.fda.gov/biologicsbloodvaccines/cellulargenetherapyproducts/approvedproducts/ucm210037.htm|title=Approved Products - Questions and Answers - Provenge|last=Research|first=Center for Biologics Evaluation and|website=www.fda.gov|language=en|access-date=2018-10-18}}
19. ^{{Cite news|url=http://www.cnn.com/2010/HEALTH/04/27/provenge.prostate.cancer.fda/|title='Landmark' cancer vaccine gets FDA approval - CNN.com|last=CNN|first=By Elizabeth Landau,|access-date=2018-10-18|language=en}}
20. ^{{Cite news|url=http://www.cnn.com/2010/HEALTH/04/27/provenge.prostate.cancer.fda/|title='Landmark' cancer vaccine gets FDA approval - CNN.com|last=CNN|first=By Elizabeth Landau,|access-date=2018-10-18|language=en}}
21. ^National Comprehensive Cancer Network . 2016. NCCN Clinical Practice Guidelines in Oncology (NCCN Guideline®): Prostate Cancer: Version 1. 2015 November 10. www.nccn.org/professionals/physician_gls/pdf/prostate.pdf.
22. ^{{Cite web|url=http://en.sanpowergroup.com/content/details_44_3873.html|title=PROVENGE to benefit from State Council meeting decision_Main Articles_News_The Sanpower Group|last=|first=|date=|website=en.sanpowergroup.com|archive-url=|archive-date=|dead-url=|access-date=}}
23. ^1 {{Cite news|url=https://www.forbes.com/sites/matthewherper/2014/05/07/is-this-how-well-cure-cancer/#b47d442781e4|title=Is This How We'll Cure Cancer?|last=Herper|first=Matthew|date=May 7, 2014|work=Forbes|access-date=|language=en}}
24. ^Ibid.
25. ^Ibid.
26. ^{{Cite web|url=https://www.fiercepharma.com/supply-chain/updated-novartis-buys-dendreon-new-jersey-plant|title=UPDATED: Novartis buys Dendreon New Jersey plant {{!}} FiercePharma|website=www.fiercepharma.com|language=en|access-date=2018-10-09}}
27. ^Mukherjee, Sy. “The Way We Treat Cancer Will Be Revolutionized As Gene Therapy Comes to the U.S”. Fortune Magazine. August 30 2017.
28. ^{{Cite web|url=https://www.fda.gov/newsevents/newsroom/pressannouncements/ucm581216.htm|title=Press Announcements - FDA approves CAR-T cell therapy to treat adults with certain types of large B-cell lymphoma|last=|first=|date=October 18, 2017|website=www.fda.gov|publisher=U.S. Food & Drug Administration|language=en|archive-url=|archive-date=|dead-url=|access-date=}}
29. ^{{Cite journal|last=Salk|first=Jonas|last2=Zannetti|first2=M|date=1987|title=Prospects for the control of AIDS by immunizing seropositive individuals|journal=Nature|volume=327|issue=6122|pages=473–476|doi=10.1038/327473a0|pmid=3587367|issn=0028-0836}}
30. ^{{Cite news|url=https://www.nytimes.com/1990/11/25/magazine/once-again-a-man-with-a-mission.html|title=Once Again, A MAN WITH A MISSION|last=Johnson|first=George|date=November 25, 1990|work=The New York Times|access-date=|language=en}}
31. ^{{Cite news|url=https://www.nytimes.com/1988/02/12/us/aids-experiment-based-on-salk-s-theories.html|title=AIDS Experiment Based on Salk's Theories|last=|first=|date=February 12, 1988|work=The New York Times|access-date=}}
32. ^{{Cite news|url=http://www.thebody.com/content/art16902.html|title=Remune Rejected: Will a Manual Recount Be Required?|last=Martinez|first=L. Joel|date=December 2000|work=The Center for AIDS Information & Advocacy|access-date=}}
33. ^{{Cite journal|last=Kahn|first=James O.|last2=Cherng|first2=Deborah Weng|date=2000-11-01|title=Evaluation of HIV-1 Immunogen, an Immunologic Modifier, Administered to Patients Infected With HIV Having 300 to 549 × 10 CD4 Cell Counts: A Randomized Controlled Trial|journal=JAMA|language=en|volume=284|issue=17|pages=2193–202|doi=10.1001/jama.284.17.2193|pmid=11056590|issn=0098-7484}}
34. ^{{Cite news|url=http://articles.latimes.com/2008/oct/16/business/fi-briefs16.S3|title=Failed vaccine, then bankruptcy|last=Services|first=From Times Wire|date=2008-10-16|work=Los Angeles Times|access-date=2018-10-18|language=en-US|issn=0458-3035}}
35. ^{{Cite news|url=https://scienceblog.com/1664/aids-vaccine-induces-hiv-specific-immune-response-in-chronic-infection/|title=AIDS vaccine induces HIV-specific immune response in chronic infection|last=|first=|date=2003-05-23|work=Massachusetts General Hospital|access-date=|language=en-US}}
36. ^{{Cite news|url=https://scienceblog.com/1664/aids-vaccine-induces-hiv-specific-immune-response-in-chronic-infection/|title=AIDS vaccine induces HIV-specific immune response in chronic infection - ScienceBlog.com|last=|first=|date=2003-05-23|work=Massachusetts General Hospital|access-date=|language=en-US}}

2 : Biotechnology companies of the United States|Immunotherapy
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