关于我们
北极星药业集团是一家专注于抗癌新药研发的跨国生物科技公司。
我们主要的研究药物 ADI-PEG 20是一个生物制剂，现已进入临床试验研究后期，研究的癌症适应症相当广泛，包括肝细胞癌、间皮瘤、胰脏癌、非小细胞肺癌、黑色素瘤以及急性骨髓性白血病等。
北极星药业集团深度参与药物开发的每一个阶段。我们集团掌握基于结构设计癌症新药的技术和全球顶尖的癌症中心合作执行临床试验，并同时于北加州和中国营运cGMP药厂。（在美国加州和中国成都建有cGMP药厂）
集团概况
北极星药业 (圣地牙哥) Polaris Pharmaceuticals – San Diego
位于美国加州圣地牙哥的Polaris Pharmaceuticals领导集团主要开发药物ADI-PEG 20之全球临床试验。创于2006年，Polaris Pharmaceuticals亦负责多种癌症适应症之早期药物研发、转译医学研究及临床前研究。
瑞华新药研发股份有限公司 TDW Pharmaceuticals
位于台湾之瑞华新药负责亚洲区域（不包含中国）之临床试验。瑞华于2008年在台湾完成了一个多中心的二期肝细胞癌临床试验，现亦负责所有ADI-PEG 20临床试验在台湾的执行。
北极星药业（瓦卡维尔）Polaris Pharmaceuticals – Vacaville
成立于2002年，并于2005年完成生物制剂之cGMP设备建置。为ADI-PEG 20临床试验提供药品已超过10年。定位是委托制造机构(CMO)，为生物科技公司提供临床试验用之生物制剂。
迪瑞药业（成都）DesigneRx Pharmaceuticals – Chengdu
成立于2013年，公司位于四川省成都市高新西区西南片区，占地约28公顷。目前正积极建置一个世界级的大规模cGMP生物制剂厂，预计于2019年完成测试生产线的验证。
迪瑞药业（上海）DesigneRx Pharmaceuticals – Shanghai
成立于2007年，上海迪瑞负责转译医学研究以开发更多可能适用ADI-PEG 20的癌症。上海迪瑞同时负责中国之临床试验执行。
管理团队
陈紹琛博士 Shaw Chen, M.D., Ph.D.
执行长 Chief Executive Officer
营运长 Chief Operating Officer
John Bomalaski, M.D.
执行副总,医药事务 Executive Vice President, Medical Affairs
何玮博士 Wei He, Ph.D.
制药资深副总 Senior Vice President, Pharmaceutical Operations
James Thomson, Ph.D.
研发资深副总 Senior Vice President, Research & Development
Amanda Johnston, Ph.D.
临床资深副总 Senior Vice President, Clinical Affairs
Peter Posel
财务副总 Vice President, Finance
Kay Huang
财务协理 AVP, Finance
科学顾问
执行中之临床试验
ADI-PEG 20正在进行数个癌症之临床试验
Drug: Pegargiminase (ADI‑PEG 20) + Pemetrexed and Cisplatin
Lead Institute: Barts Cancer Institute
ATOMIC Study (Phase 2/3)
Phase 2/3 Study in Subjects with MPM to Assess ADI‑PEG 20 with Pemetrexed and Cisplatin (ATOMIC)
This is a randomized, double-blind, pivotal Phase 2/3 study in patients with non-epithelioid (including biphasic and sarcomatoid histologies) malignant pleural mesothelioma (MPM) to assess the effect of Pegargiminase with pemetrexed and cisplatin, the current first-line standard of care chemotherapies for MPM. The study uses an adaptive biomarker-driven design with an interim analysis to be conducted at the end of Phase 2. Patients in the study are required to have tumor samples submitted for biomarker analysis. This study is being conducted at multiple centers globally and is currently recruiting patients. Learn more
Drug: Pegargiminase (ADI‑PEG 20) + FOLFOX
Lead Institute: Memorial Sloan-Kettering Cancer Center
FOLFOX Study (Phase 2)
Phase 1/2 Study of ADI‑PEG 20 Plus FOLFOX in Subjects with Advanced Gastrointestinal Malignancies
The Phase 2 portion of the study is designed as a pivotal single-arm, open-label study to assess the effect of Pegargiminase in combination with folinic acid (leucovorin), fluorouracil and oxaliplatin (FOLFOX) for treatment of hepatocellular carcinoma (HCC) patients who have failed at least two lines of prior systemic treatments. The phase 2 portion of the study is being conducted at multiple centers globally, and currently recruiting patients.
The already concluded Phase 1 portion established safety and tolerability of combining Pegargiminase with FOLFOX for the treatment of advanced GI malignancies including HCC, colorectal cancer, and gastric cancer. Learn more
Drug: Pegargiminase (ADI-PEG 20) + Gemcitabine and Docetaxel
Lead Institute: Washington University School of Medicine
Sarcoma Study (Phase 2)
ADI-PEG 20 in Combination with Gemcitabine and Docetaxel for the Treatment of Soft Tissue Sarcoma
This is an open-label, Phase 2 study of Pegargiminase in combination with gemcitabine and docetaxel, a standard second line therapy, for patients with soft tissue sarcoma. The investigator has recently demonstrated that by depleting arginine, Pegargiminase induced metabolic changes to sensitize tumor cells to the killing effect of gemcitabine. The study is intended to assess if the clinical benefit rate of gemcitabine and docetaxel is improved by the metabolic changes induced by Pegargiminase. Learn more
Drug: Pegargiminase (ADI‑PEG 20 + Pembrolizumab
Lead Institute: Taiwan National Institute Cancer Research
Pembrolizumab (Phase 1)
Phase 1 Study of ADI‑PEG 20 Plus Pembrolizumab in Advanced Solid Cancers
This is an open-label, Phase 1b study of Pegargiminase in combination with pembrolizumab in patients with advanced solid cancers who have failed prior treatment. In addition to assessing the safety and tolerability of combining Pegargiminase and pembrolizumab, this study also intends to explore the effect of this combination in head and neck tumors. The study is open and currently recruiting patients. Learn more
已完成的临床试验
除了正在执行的临床试验外，北极星已完成ADI-PEG 20在多项癌症适应症的研究。
| 癌症類型 | 治療方式 | 領導之癌症中心 | 試驗期別 |
|---|---|---|---|
| 肝細胞癌 | 單一療法 | 美國紐約 Memorial Sloan-Kettering Cancer Center | Phase 3 |
| 間皮瘤 | 單一療法 | 英國倫敦 Barts Cancer Institute | Phase 2 |
| 黑色素瘤 | 單一療法 | 美國紐約 Memorial Sloan-Kettering Cancer Center | Phase 2 |
| 非何杰金淋巴癌 | 單一療法 | 台灣國家衛生研究院 Tawain National Health Research Institue (NHRI) | Phase 2 |
| 急性骨髓性白血病 | 單一療法 | 台灣國家衛生研究院 + 美國德州大學安德森癌症中心 Tawain NHRI + MD Anderson Cancer Center | Phase 2 |
| 小細胞肺癌 | 單一療法 | 美國紐約 Memorial Sloan-Kettering Cancer Center | Phase 2 |
| 胰臟癌 | +Nab-paclitaxel +Gemcitabine | 美國紐約 Memorial Sloan-Kettering Cancer Center | Phase 1 |
| 間皮瘤、非小細胞肺癌、膠質瘤、葡萄膜黑色素瘤、肉瘤樣腫瘤 | +Pemetrexed +Cisplatin | 英國倫敦 Barts Cancer Institute | Phase 1 |
| 皮膚黑色素瘤、葡萄膜黑色素瘤、卵巢癌、肝細胞癌、膽管癌 | +Cisplatin | 美國德州大學安德森癌症中心 MD Anderson Cancer Center | Phase 1 |
| 急性骨髓性白血病 | + Cytarabine | 台灣國立成功大學醫學院附設醫院 Taiwan National Cheng Kung University Hospital | Phase 1 |
| 乳癌 | +Doxorubicin | 美國德州大學安德森癌症中心 MD Anderson Cancer Center | Phase 1 |
| 結直腸癌、胃癌 | +FOLFOX | 台灣國立成功大學醫學院附設醫院 Taiwan National Cheng Kung University Hospital | Phase 1 |
| 前列腺癌、非小細胞肺癌 | +Docetaxel | 美國加州大學戴維斯分校醫學中心 UC Davis Medical Center | Phase 1 |
科学论述
阻挡多种癌症的代谢关键
ADI-PEG 20是一个蛋白质新药，而其正在发展的适应症都有一个特殊的共同点 － 这些癌细胞皆不能制造精氨酸，一个对于癌细胞增生及存活不可或缺胺基酸。因为这些癌细胞不能自行制造精氨酸，他们必须依赖病患血液里的精氨酸。然而ADI-PEG 20经由把血液里的精氨酸转为瓜胺酸，剥夺了这些癌细胞的营养来源。
健康的细胞可以轻易地经由尿素循环将瓜胺酸转换为精氨酸，但癌细胞不能，由于其负责生产精氨酸的精胺琥珀酸合成酶(argininosuccinate synthase, ASS1)功能低下。为了存活，癌细胞必须“重写”其代谢途径，但这个过程会带给癌细胞压力，让传统化学治疗更加有效。
北极星正在评估ADI-PEG 20合并传统治疗及免疫疗法的安全性及疗效。ADI-PEG 20已在美国和欧盟获得肝细胞癌、黑色素疗（仅美国）及间皮瘤的孤儿药资格。
美国FDA已提供我们特殊计划评估(Special Protocol Assessment)，欧盟EMEA亦提供计划协助，大大增加快速取得药证可能性。
北极星药业集团拥有数个ADI-PEG 20专利（包含核准及申请中），涵盖制剂到使用方法。
研究计划
POL20000
Polaris Group is working to identify and develop the next generation of arginine-depleting therapeutic proteins. ADI‑PEG 20 is based on an enzyme, ADI (arginine deiminase), that originates from the micro-organism Mycoplasma hominis. Because ADI is from a foreign source, prolonged treatment will give rise to anti-ADI‑PEG 20 antibodies that will reduce the drug’s effectiveness. To minimize the impact of neutralizing antibodies, ADI has been PEGylated using the same technology as is used for other FDA-approved therapeutic proteins.
To further counter neutralizing antibodies, Polaris is developing a follow-up drug based on a protein that is distantly related to M. hominis ADI from M. hominis. Promising enzymes are currently undergoing more extensive characterization and additional genetic engineering. The second-generation drug will be developed with comparable or superior characteristics as the first generation, including enzyme activity under physiological conditions, pharmacodynamics and pharmacokinetic properties. Polaris owns issued or pending patents covering PEGylated ADI originating from new species and chimeric proteins.
POL30000
Tumor necrosis factor (TNF)-related apoptosis-inducing ligand, or TRAIL, is a member of the TNF superfamily that can initiate cell death. The ability of TRAIL to selectively induce apoptosis in tumor cells, but not normal cells, renders TRAIL-based therapy a safe and efficacious approach to targeting cancer. Cytokines induce apoptosis through the activation of death receptors via receptor oligomerization, which in turn results in the recruitment of specialized adaptor proteins and activation of caspase cascades.
Polaris has designed and synthesized multiple TRAIL-based biologics and has advanced this project to pre-clinical candidate selection. A representative of these molecules has shown significant efficacy in mouse models. Polaris has filed a provisional patent on this highly novel class of biotherapeutics.
POL40000
Protein kinases play a global role in cell growth, death and survival. In many cancers, these proteins are dysregulated and overexpressed, making them attractive therapeutic targets. Polaris has a program developing small-molecule inhibitors of a dysregulated protein kinase and owns issued and pending patents covering different structural classes of such small-molecule inhibitors.
POL50000
Immune checkpoint inhibitors have seen much success as cancer therapies in recent years. Polaris is developing a small-molecule based therapy that seeks to block one of the immune checkpoints, thereby decreasing tumor-induced immune suppression. Small-molecule drugs have several advantages over antibody-based drugs; they can be administered orally, have a shorter half-life making it easier to manage adverse events, and have lower manufacturing costs. Polaris has filed a provisional patent covering its first structural class of small molecule checkpoint inhibitors.
ASS1 IHC Assay
The ASS1 IHC assay is a standard laboratory immunohistochemistry (IHC) assay. Using Polaris’ proprietary mouse monoclonal antibody against ASS1, it is developed for the in vitro semi-quantitative detection of ASS1 antigen in sections of formalin-fixed, paraffin-embedded (FFPE) normal and neoplastic tissues. Visualization of the ASS1 antigen is achieved by sequential application of the anti-ASS1 primary antibody, visualization reagents and chromagen, resulting in a visible reaction at the site of the antigen. Results are evaluated by a pathologist using a light microscope. Polaris mouse anti-ASS1 monoclonal antibodies can be used in detecting ASS1 protein expression in both Western blot and IHC.
制药生产
北极星药业集团用最先进的制药设备，在加州及中国制造药品以供临床试验及商业化使用。
北极星药业（瓦卡维尔）Polaris Pharmaceuticals – Vacaville,
位于美国加州的瓦卡维尔，负责制造所有北极星全球临床试验所需之药品。其cGMP药厂生产蛋白质新药以供美国、欧洲及亚太平洋区不同阶段的临床试验使用。
迪瑞药业（成都）DesigneRx Pharmaceuticals – Chengdu, 成立于2013年，公司位于四川省成都市高新西区西南片区。身为北极星药业集团的全资子公司，成都迪瑞计划建置一个小规模之临床试验生产线，及一个商业规模之cGMP产线，用以生产生物制剂。
最新消息
Polaris Group Announces Wayne Lin as New COO
February 22, 2019
Polaris Group Announces Dr. Shaw Chen as New Interim CEO
February 22, 2019
Polaris Announces Dr. Chi Van Dang Joining its Scientific Advisory Board
July 8, 2018
Polaris Announces Drs. James Allison and Padmanee Sharma Joining its Scientific Advisory Board
June 3, 2018
May 31, 2018
May 10, 2018