引領更新和更好的癌症治療方法

關於我們

北極星藥業集團是一家專注於抗癌新藥研發之跨國生物科技公司。

我們主要的研究藥物 ADI-PEG 20是一個生物製劑，現已進入臨床試驗研究後期，研究的癌症適應症相當廣泛，包括肝細胞癌、間皮瘤、胰臟癌、非小細胞肺癌、黑色素瘤以及急性骨髓性白血病等。

北極星藥業集團深度參與藥物開發的每一個階段。我們集團掌握基於結構設計癌症新藥的技術、和全球頂尖的癌症中心合作執行臨床試驗，並在美國加州和中國成都建有cGMP藥廠。

集團概況

北極星藥業 (聖地牙哥) Polaris Pharmaceuticals – San Diego

位於美國加州聖地亞哥的 Polaris Pharmaceuticals 領導集團主要開發藥物ADI-PEG 20之全球臨床試驗。創於2006年，Polaris Pharmaceuticals 亦負責多種癌症適應症之早期藥物研發、轉譯醫學研究及臨床前研究。

瑞華新藥研發股份有限公司 TDW Pharmaceuticals

位於台灣之瑞華新藥負責亞洲區域（不包含中國）之臨床試驗。瑞華於2008年在台灣完成了一個多中心的二期肝細胞癌臨床試驗，現亦負責所有ADI-PEG 20臨床試驗在台灣的執行。

北極星藥業（瓦卡維爾）Polaris Pharmaceuticals – Vacaville

成立於2002年，並於2005年完成生物製劑之cGMP設備建置。為ADI-PEG 20臨床試驗提供藥品已超過10年。定位是委託製造機構(CMO)，為生物科技公司提供臨床試驗用之生物製劑。

迪瑞藥業（成都）DesigneRx Pharmaceuticals – Chengdu

成立於2013年，公司位於四川省成都市高新西區西南片區，占地約28公頃。目前正積極建置一個世界級的大規模cGMP生物製劑廠，預計於2019年完成測試生產線的驗證。

迪瑞藥業（上海）DesigneRx Pharmaceuticals – Shanghai

立於2007年，上海迪瑞負責轉譯醫學研究以開發更多可能適用ADI-PEG 20的癌症。上海迪瑞同時負責中國之臨床試驗執行。

管理團隊

John Bomalaski, M.D.

執行副總,醫藥事務 Executive Vice President, Medical Affairs

Chris Huxsoll, Ph.D.

營運資深副總 Senior Vice President, Operations

Amanda Johnston, Ph.D.

臨床資深副總 Senior Vice President, Clinical Affairs

Richard E. Showalter, B.A.

副總, 研發部門 Vice President, Research and Development

執行中之臨床試驗

ADI-PEG 20正在進行數個癌症之臨床試驗

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Mesothelioma

Phase 2 / 3 (Registration study)

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

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HCC

Phase 2 (Registration study)

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

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Soft Tissue Sarcoma

Phase 2

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. The study expects to enroll a total of 90 patients (including 75 with soft tissue sarcoma, 15 with non-soft tissue sarcoma) Learn more

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Head and Neck Cancer

Phase 1

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

已完成的臨床試驗

除了正在執行的臨床試驗外，北極星已完成ADI-PEG 20在多項癌症適應症的研究。

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

科學研究

阻擋多種癌症的代謝關鍵

ADI-PEG 20是一個蛋白質新藥，而其正在發展的適應症都有一個特殊的共同點－這些癌細胞皆不能製造精氨酸，一個對於癌細胞增生及存活不可或缺胺基酸。因為這些癌細胞不能自行製造精氨酸，他們必須依賴病患血液裡的精氨酸。然而ADI-PEG 20經由把血液裡的精氨酸轉為瓜胺酸，剝奪了這些癌細胞的營養來源。

健康的細胞可以輕易地經由尿素循環將瓜胺酸轉換為精氨酸，但癌細胞不能，由於其負責生產精氨酸的精胺琥珀酸合成酶(argininosuccinate synthase, ASS1)功能低下。為了存活，癌細胞必須「重寫」其代謝途徑，但這個過程會帶給癌細胞壓力，讓傳統化學治療更加有效。

北極星正在評估ADI-PEG 20合併傳統治療及免疫療法的安全性及療效。ADI-PEG 20已在美國和歐盟獲得肝細胞癌、黑色素療（僅美國）及間皮瘤的孤兒藥資格。

美國FDA已提供我們特殊計畫評估(Special Protocol Assessment)，歐盟EMEA亦提供計畫協助，大大增加快速取得藥證可能性。

北極星藥業集團擁有數個ADI-PEG 20專利（包含核准及申請中），涵蓋製劑到使用方法。

了解更多

研究計畫

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.

製藥生產

北極星藥業集團用最先進的製藥設備，在加州及中國製造藥品以供臨床試驗及商業化使用。

北極星藥業（瓦卡維爾）Polaris Pharmaceuticals – Vacaville,

位於美國加州的瓦卡維爾，負責製造所有北極星全球臨床試驗所需之藥品。其cGMP藥廠生產蛋白質新藥以供美國、歐洲及亞太平洋區不同階段的臨床試驗使用。

迪瑞藥業（成都）DesigneRx Pharmaceuticals – Chengdu, 成立於2013年，公司位於四川省成都市高新西區西南片區。身為北極星藥業集團的全資子公司，成都迪瑞計畫建置一個小規模之臨床試驗生產線，及一個商業規模之cGMP產線，用以生產生物製劑。

引領更新和更好的癌症治療方法

關於我們

集團概況

北極星藥業 (聖地牙哥) Polaris Pharmaceuticals – San Diego

瑞華新藥研發股份有限公司 TDW Pharmaceuticals

北極星藥業（瓦卡維爾）Polaris Pharmaceuticals – Vacaville

迪瑞藥業（成都）DesigneRx Pharmaceuticals – Chengdu

迪瑞藥業（上海）DesigneRx Pharmaceuticals – Shanghai

管理團隊

陳紹琛博士Shaw Chen, M.D., Ph.D.

林維源 Wayne Lin, MBA

John Bomalaski, M.D.

Chris Huxsoll, Ph.D.

Amanda Johnston, Ph.D.

黃藍瑩 Kay Huang

Richard E. Showalter, B.A.

執行中之臨床試驗

Mesothelioma

HCC

Soft Tissue Sarcoma

Head and Neck Cancer

已完成的臨床試驗

科學研究

研究計畫

製藥生產

最新消息

聯絡我們

引領 更新和更好的 癌症治療方法

關於我們

集團概況

管理團隊

執行中之臨床試驗

Mesothelioma

HCC

Soft Tissue Sarcoma

Head and Neck Cancer

已完成的臨床試驗

科學研究

研究計畫

製藥生產

最新消息

聯絡我們

引領更新和更好的癌症治療方法