Leading the way to new and better cancer treatments.

About Polaris

Polaris Group is a multinational biotechnology company focused on developing novel anti-cancer therapies.

Our lead drug candidate, Pegargiminase (ADI‑PEG 20), is a biologic in late-stage clinical development for a wide range of cancers, including hepatocellular carcinoma, mesothelioma, pancreatic cancer, non-small cell lung cancer, melanoma, acute myeloid leukemia and others.

Polaris Group is involved in every stage of the drug development process. Our family of companies harnesses structure-based drug design technology to create novel oncology therapies, conducts clinical studies at top-tier cancer centers worldwide and operates CGMP production facilities in Northern California and China.

Family of Companies

Polaris Pharmaceuticals – San Diego

San Diego-based Polaris Pharmaceuticals is leading clinical development of Polaris Group’s lead drug candidate, Pegargiminase. Founded in 2006, the company also conducts early-stage drug discovery, translational research and pre-clinical research for a variety of cancer indications and is executing global clinical studies for Pegargiminase.

TDW Pharmaceuticals

TDW, based in Taiwan, is responsible for clinical studies in Asia, outside of China. TDW completed a multi-center Phase 2 clinical study in Taiwan for hepatocellular carcinoma in 2008, and is conducting multiple studies for Pegargiminase in Taiwan.

Polaris Pharmaceuticals – Vacaville

Founded in 2002. Built a cGMP facility for biologics in 2005 and has been providing Pegargiminase for all clinical studies for over 10 years. As a CMO, manufactured cGMP grade biologics for a biotech company to conduct clinical studies in the USA.

DesigneRx Pharmaceuticals – Chengdu

Founded in 2013. Acquired 68 acres in Chengdu Hightech Industrial Park in 2013. Currently building a world-class large scale cGMP facility for biologics; pilot facility projected to be validated in 2019.

DesigneRx Pharmaceuticals – Shanghai

Founded in 2007, DesigneRx Pharmaceuticals – Shanghai conducts translational research to identify additional cancers that may be suitable for treatment with Pegargiminase. The business also is responsible for the clinical development of Pegargiminase in China.

Management Team

Shaw Chen, M.D., Ph.D.

Chief Executive Officer

Wayne Lin, MBA

Chief Operating Officer

John Bomalaski, M.D.

Executive Vice President, Medical Affairs

Chris Huxsoll, Ph.D.

Senior Vice President, Operations

Amanda Johnston, Ph.D.

Senior Vice President, Clinical Affairs

Kay Huang

CFO, Finance

Richard E. Showalter, B.A.

Vice President, Research and Development

Ongoing Clinical Studies

Pegargiminase is in clinical development for numerous oncology indications.

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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

Completed Clinical Studies

In addition to our ongoing clinical trials, we have evaluated Pegargiminase in completed studies for a range of oncology indications.

Tumor Type	Treatment Type	Lead Clinical Site	Phase
Hepatocellular Carcinoma	Monotherapy	Memorial Sloan-Kettering Cancer Center	Phase 3
Mesothelioma	Monotherapy	Barts Cancer Institute	Phase 2
Melanoma	Monotherapy	Memorial Sloan-Kettering Cancer Center	Phase 2
Non Hodgkin’s Lymphoma	Monotherapy	Tawain National Health Research Institue (NHRI)	Phase 2
Acute Myeloid Leukemia	Monotherapy	Tawain NHRI + MD Anderson Cancer Center	Phase 2
Small Cell Lung Carcinoma	Monotherapy	Memorial Sloan-Kettering Cancer Center	Phase 2
Pancreatic Cancer	+Nab-paclitaxel +Gemcitabine	Memorial Sloan-Kettering Cancer Center	Phase 1
Mesothelioma, Non-Small Cell Lung Carcinoma, Glioma, Uveal Melanoma, Sarcomatoid Tumors	+Pemetrexed +Cisplatin	Barts Cancer Institute	Phase 1
Cutaneous and Uveal Melanoma, Ovarian Cancer, HCC, Biliary Tract Cancer	+Cisplatin	MD Anderson Cancer Center	Phase 1
Acute Myeloid Leukemia	+ Cytarabine	Taiwan National Cheng Kung University Hospital	Phase 1
Breast Cancer	+Doxorubicin	MD Anderson Cancer Center	Phase 1
Colorectal, Gastric Cancer	+FOLFOX	Taiwan National Cheng Kung University Hospital	Phase 1
Prostate Cancer, Non-Small Cell Lung Carcinoma	+Docetaxel	UC Davis Medical Center	Phase 1

Our Science

Acting on a Metabolic Linchpin of Many Cancers

Pegargiminase is a novel therapeutic protein being developed for cancers with a unique metabolic trait: their cells are unable to create arginine, an amino acid that is essential for cancer cell proliferation and survival. Because the cells can’t create arginine on their own, they must rely on arginine in the patient’s plasma. But Pegargiminase deprives the cancer cells of this amino acid by converting plasma-borne arginine into citrulline.

While healthy cells are able to easily convert citrulline back into arginine through a process known as the urea cycle, cancer cells are not. At the core of their deficiency is a down-regulation of argininosuccinate synthase (ASS1), an enzyme needed to synthesize arginine. To survive, the cancer cells must “rewire” their metabolism. This exerts a stress on the cells that renders them more susceptible to conventional chemotherapies.

Polaris is evaluating Pegargiminase in combination with standard chemotherapies and immuno-oncology drugs. The candidate has gained orphan drug status for hepatocellular carcinoma, melanoma and mesothelioma in the U.S., also for mesothelioma and hepatocellular carcinoma in Europe.

The FDA also has provided Special Protocol Assessment and the EMEA has provided Protocol Assistance, allowing for the potential of expedited market approval.

Polaris Group owns multiple issued and pending patents covering Pegargiminase, including patents on formulation and use.

View Publications

Research Programs

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.

Manufacturing

Polaris Group operates state-of-the-art production facilities in California and China to manufacture its therapies for clinical trials and commercialization.

Polaris Pharmaceuticals – Vacaville, located in Vacaville, California, manufactures all drugs for Polaris Group’s global clinical studies. The cGMP facility produces novel protein therapeutics to support clinical trials at various stages in the U.S., Europe and the Asian-Pacific region.

DesigneRx Pharmaceuticals – Chengdu, established in 2013, is located in the Hi-Tech Zone of Chengdu in the Sichuan province in China. As a wholly owned subsidiary of Polaris Group, this facility is designed to include a small-scale clinical manufacturing suite and a commercial-scale cGMP manufacturing facility for biologic drugs.