Dendreon
Parent Sanpower Group, Nanjing, CN | | |
Website | dendreon |
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Dendreon is a
In November 2014, Dendreon filed for
On February 20, 2015,
Technology overview and pipeline
This section needs additional citations for verification. (May 2010) |
Antigen delivery cassette and antigen presenting cells
Dendreon's name derives from the "Dendritic Cell" which forms a major component of the company's product candidates that use the "Dendreon Cassette Technology" to insert a disease-specific target protein into a general platform. Their lead product, Provenge, is an example of their "rationally designed therapeutic process" intended to break immune tolerance to certain disease specific proteins. It is hypothesized that receptor mediated uptake of antigen by dendritic cells occurs when they are exposed to the Dendreon fusion protein which links the disease specific protein to a recognition protein. This approach is in contrast to other dendritic cell vaccines that use methods such as electroporation to get the DC's to present antigen related epitopes. In the case of Provenge, this disease related protein is prostatic acid phosphatase and the signalling component is GM-CSF.
Antigen selection
Dendreon believes its process can be optimized and generalized to other diseases by exchanging the PAP component of Provenge with better targets specific to different diseased cells.
Prior work in this area has also included that of A. Sette at Epimmune and the Altered Peptide Ligand approach typified by Neurocrine Biotech's failed MS drug.
Nuvelo and patents acquired from Corvas
Dendreon acquired the nematode anticoagulant Nuvelo.[13] Selected Corvas patents include technologies for peptide analog synthesis and drugs that target coagulation and immune processes.
Early history
Drs. Haseltine, Engleman, and Strober established the company, initially named Activated Cell Therapy, in Mountain View, California, after securing funding from Health Care Ventures in Edison, New Jersey. The company successfully brought to market the first approved cell-based immune therapy, Provenge, for the treatment of metastatic prostate cancer[14] After several years the company changed its name to Dendreon and moved to Seattle, Washington, under Christopher Henney.
Provenge
Initial clinical results for Provenge in 2000 showed immune responses supporting the expected mode-of-action, as well as a PSA reduction which was thought to relate to clinical improvement.
On March 29, 2007, the FDA Office of Cellular, Tissue and Gene Therapies Advisory Committee voted 17-0 that Provenge is reasonably safe and 13-4 that the trial data showed substantial evidence that it is effective.[18] However, on May 9, 2007, Dendreon received a letter from the FDA demanding more results and information before approval.[19]
On April 14, 2009, Dendreon announced that the results for the Phase III trial of Provenge were positive, saying there had been a reduction in the odds of death compared to the use of a placebo.[20] On April 28, 2009, the full details of the study were released. The trial found that patients treated with Provenge lived an average of 4.1 months longer than patients treated with the control (autologous cells without the GM-CSF / PAP fusion protein).[21]
On April 29, 2010, the FDA approved Provenge for use in the treatment of advanced prostate cancer.
On June 7, 2010, the head of Medicare's Coverage and Analysis Group, Dr. Louis Jacques, sent three colleagues an email telling them that they should be sure not to leak the fact that his Group was considering a cap on Medicare coverage of this treatment. News of that caution itself did inevitably leak, and the price of Dendreon's stock fell 10% later that day.
Dendreonites
Some journalists have referred to Provenge supporters as "Dendreonites" and the name is in routine usage in colloquial forums.[22] Concerns for personal safety were raised among some doctors who were thought responsible for the delay of Provenge approval.[23] Dendreonites have questioned these doctors' objectivity; one of them, Dr. Howard Scher, was the lead clinical trial investigator for a rival prostate cancer drug from the biotech company Novacea.[22] Their concerns motivated organized protests at the FDA and American Society of Clinical Oncology (ASCO) meeting by various patient and investor advocacy groups which also filed a lawsuit alleging that the FDA's decision was influenced by conflicts of interest.[24]
References
- ^ "AUA IMPACT Trial Presentation Summary" (PDF). Archived from the original (PDF) on 2011-10-01. Retrieved 2009-04-29.
- ^ "UPDATE 3-U.S. FDA OKs Dendreon's prostate cancer vaccine". Reuters. 29 April 2010. Retrieved 2010-05-02.
- ^ Berkrot, Bill (4 August 2011). "Dendreon plunges as Provenge prospects wither". Reuters. Retrieved 2011-08-04.
- ^ "Dendreon files for Chapter 11 bankruptcy" (Press release). Reuters. 10 November 2014.
- ^ "Valeant to sell Dendreon unit to China's Sanpower for $820 million". Reuters. 1 January 2017. Retrieved Mar 19, 2019.
- ^ "Sanpower Group Completes the Acquisition of Dendreon from Valeant". PR Newswire. 29 June 2017.
- ^ "BBC Global News." Interview by Julian King and Otis Brawley. GlobalNews (0400 GMT). BBC UK Podcast. London. 30 April 2010. Podcast.
- PMID 19293179.
- PMID 18940592.
- PMID 19322680.
- PMID 19128049.
- PMID 19108401.
- PMID 15083600.
- ^ "Activated Cell Therapy Announces New Executive Management Team" (Press release). Activated Cell Therapy. 30 August 1995. Retrieved 30 June 2009.
- PMID 11099318.[permanent dead link]
- ^ Timmerman, Luke (9 August 2006). "Building factory a balancing act for Dendreon". The Seattle Times. Archived from the original on 10 March 2007. Retrieved 29 June 2009.
- TheStreet.com. Archived from the originalon 8 March 2008. Retrieved 29 June 2009.
- ^ "US panel: Dendreon cancer therapy appears to work". Reuters. 29 March 2007. Retrieved 30 June 2009.
- Forbes.com. Retrieved 9 May 2007.
- ^ Pollack, Andrew (14 April 2009). "Promising Test for Dendreon's Prostate Cancer Drug". The New York Times. Retrieved 30 June 2009.
- ^ "Dendreon Reports PROVENGE Regulatory and Commercialization Progress and Future Pipeline Plans at Analyst Event (NASDAQ:DNDN)". Archived from the original on 2011-07-09. Retrieved 2009-10-26.
- ^ a b "CNBC Article on Dendreonite Requests". Archived from the original on 2011-07-08. Retrieved 2009-05-01.
- ^ Stein, Rob. "FDA Delay In Cancer Therapy Is Attacked". The Washington Post. Retrieved 2010-05-01.
- ^ Roan, Shari (December 31, 2007). "Protest Descriptions". The Los Angeles Times.