① Dendreon Corp (www.dendreon.com)
미국 생명공학사 덴드리온(Dendreon)은 수지상세포를 이용한 항암면역세포치료제 프로벤지를 개발했습니다.
수지상세포는 면역계의 항원제시세포로, 종양 항원을 인식해 면역계의 T세포에게 제시함으로써 T세포가 동일한 항원을 지닌 암세포를 색출해 파괴하도록 합니다. 프로벤지는 전립선 암세포의 약 95%에서 발현되는 '전립선 산성 인산분해효소'(PAP)를 종양항원으로 활용합니다.
2009년 4월 28일 시카고에서 열린 미국비뇨기과학회(AUA) 연례회의에서 프로벤지의 3상 임상시험인 'IMPACT' 연구 결과를 공개했습니다. 데이터에 따르면, 프로벤지는 위약에 비해 진행성 전립선암 환자들의 평균 생존기간을 4.1개월 연장하고(25.8개월 대 21.7개월) 3년 생존율을 38% 개선했습니다(31.7% 대 23.0%)
아울러 프로벤지는 위약보다 사망위험을 22.5% 감소시키고 부작용은 오한, 발열과 두통 정도로 대개 경미하고 주사 후 하루나 이틀 정도 지속돼 이전 임상들에서와 같이 안전성도 매우 우수한 것으로 나타났습니다.
이 연구는 증상이 없거나 미미한 진행성(전이성), 항호르몬제 무반응 전립선암 환자 512명을 참여시켜 프로벤지 또는 위약으로 치료를 시작했습니다. 위약군은 종양이 진행하면 곧 동결형 프로벤지를 투여 받았고 이어 항암제 '탁소텔'(Taxotere, docetaxel)로 치료받았으며, 프로벤지군도 치료에 대해 반응을 멈추면 탁소텔을 투여 받았습니다.
덴드리온은 이러한 데이터에 근거하여 2010년 4월 29일 미국FDA로 부터 프로벤지를 승인 받았습니다. 프로벤지는 전립선암 치료에 있어 항암화학치료제를 대체하거나 부작용이 많은 화학치료제의 사용을 지연시키는 치료로 쓰여 연 20억 달러의 매출을 올릴 것으로 업계분석가들은 전망하고 있습니다.
<덴드리온 홈페이지의 회사소개 전문>
Dendreon Corporation (NASDAQ: DNDN), a Seattle-based biotechnology company, is focused on targeting cancer to transform lives through the discovery, development and commercialization of novel therapeutics to fight cancer.
Dendreon applies its expertise in antigen identification, engineering and cell processing to produce Active Cellular Immunotherapy (ACI) product candidates designed to stimulate an immune response. ACI holds promise because it may provide patients with a meaningful clinical benefit, such as survival, combined with low toxicity. In addition to ACI product candidates, the company is also developing an orally-available small molecule targeting TRPM8 that could be applicable to multiple types of cancer as well as benign prostatic hyperplasia.
Dendreon's lead ACI product candidate, known as PROVENGE? (sipuleucel-T)
Sipuleucel-T) is in late-stage development for the treatment of men with metastatic, androgen-independent prostate cancer.
ACTIVE CELLULAR IMMUNOTHERAPY
Dendreon is at the forefront of introducing the first in a new class of therapy known as Active Cellular Immunotherapies(ACIs). ACIs use the power of live human cells to engage the patient's own immune system.
Activated T cells may be the immune system's most potent defense against cancer. Although a variety of immune cells participate in the surveillance and elimination of cancer cells, T cells are uniquely endowed to kill specific tumor cell types. When activated to recognize tumor-associated antigens, T cells proliferate and attack cells bearing those antigens. For this reason, the goal of many investigational ACIs is to stimulate and optimize activation of T cells.
The cell orchestrators of T cell activation are antigen presenting cells (APCs).
When encountering tumor-associated antigens in the body, APCs process and display the antigens, and then present them to T cells. When activated by APCs, T cells may recognize and lyse cells bearing those antigens.
The goal of Dendreon's approach is to turn the immune system "back on" to elicit a specific and long-lasting response against cancer. We do this by isolating and activating APCs using proprietary methods. We then fabricate an Antigen Delivery Cassette™ Antigen Delivery Cassette™
Dendreon's proprietary approach for antigen modification. The cassette allows for the engineering or modification of tumor antigens to augment the uptake and processing of the antigen by dendritic cells to increase the potency of an immune response. Close by combining the APCs with a bio-engineered target antigen. These enhanced APCs now have the ability to alert the patient's T cells to attack the cancer.
② Northwest Biotherapeutics, Inc. (//www.nwbio.com)
Northwest Biotherapeutics, Inc. is a development stage biotechnology company focused on discovering, developing and commercializing immunotherapy products that generate and enhance immune system responses to treat cancer. The Company operates in the United States and is incorporated in Delaware, USA. Currently approved cancer treatments are frequently ineffective, can cause undesirable side effects and provide marginal clinical benefits. The Company’s approach in developing cancer therapies utilizes its expertise in the biology of dendritic cells, which are a type of white blood cell that activate the immune system. The Company’s cancer therapies have been demonstrated in clinical trials to significantly extend both time to recurrence and survival, whilst providing a superior quality of life with no debilitating side effects when compared with current therapies.
The Company’s platform technology, DCVax?, uses a patient’s own dendritic cells, the starter engine of the immune system. The dendritic cells are extracted from the body, loaded with tumor biomarkers or ‘‘antigens’’, thereby creating a personalized therapeutic vaccine. Injection of these cells back into the patient initiates a potent immune response against cancer cells, resulting in delayed time to progression and prolonged survival. The Company’s lead product candidate is DCVax?-Brain which targets Glioblastoma Multiforme (‘‘GBM’’), the most lethal form of brain cancer. DCVax?-Brain has entered a Phase II FDA-allowed clinical trial, which is designed and powered as a pivotal trial (i.e. a trial from which a company may go directly to product approval). Following this trial, the Company anticipates filing a biologic license application (or ‘‘BLA’’) with the FDA for DCVax?-Brain. DCVax?-Prostate, which targets hormone independent (i.e. late stage) prostate cancer, has also been cleared by the FDA to commence a Phase III clinical trial, which is also designed and powered as a pivotal trial.
DCVax? is a platform technology that can be applied to multiple cancers. It combines a patient’s own dendritic cells (DC) with cancer related proteins, or antigens, with the aim of inducing immune responses against a patient’s cancer cells. Our early-stage clinical trial data, and those of our collaborators, suggest that DCVax?-Prostate and DCVax?-Brain may have the ability to significantly delay disease progression, in addition to possibly prolonging patient survival, while maintaining a good quality of life. DCVax?-Prostate and DCVax?-Brain are designed to have the following characteristics, which would make them and other DCVax? product candidates attractive therapeutic additions to current treatments.
Activation of The Natural Immune System : Our DCVax? platform is designed to naturally elicit an immune response against a patient’s cancer. We believe that this response can be effectively accomplished through the injection in the skin of DC that are "educated" to teach the immune system to recognize, and kill cancer cells. Our clinical trials to date, and those of our collaborators, suggest that this immune response may be effective in delaying time to disease progression in brain and prostate cancer, and may significantly prolong survival in brain cancer while maintaining good quality of life.