Pipeline

Clinical Trials

Pegargiminase is in clinical development for numerous oncology indications.

Phase 3 BLA Rolling Submission

Mesothelioma

Drug: Pegargiminase (ADI‑PEG 20) + Pemetrexed and Cisplatin
Lead Institute: Barts Cancer Institute

ATOMIC Study (Phase 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. This study is being conducted at multiple centers globally. The interim analysis showed the conditional power (CP) for the overall survival (OS) evaluation in the ITT population was >80% on Feb 2021. 

On September 21st, 2022 Polaris announced successful top-line results from phase 2/3 atomic study in patients with the Malignant Pleural Mesothelioma (MPM) to assess ADI-PEG 20 with Pemetrexed and Cisplatin.
Phase 3 BLA Rolling Submission

Phase 3

Soft Tissue Sarcoma

Drug: Pegargiminase (ADI-PEG 20) + Gemcitabine and Docetaxel
Lead Institute: Washington University School of Medicine

Sarcoma Study (Phase 3)

ADI-PEG 20 in Combination with Gemcitabine and Docetaxel for the Treatment of Soft Tissue Sarcoma

This is an open-label, Phase 3 study of Pegargiminase in combination with gemcitabine and docetaxel, a standard second line therapy, for patients with soft tissue sarcoma. The investigator Dr. Van Tine has recently demonstrated that ADI-PEG 20 together with docetaxel enhanced the activity of the human equilibrative nucleoside transporter (hENT1), thus increasing the influx of gemcitabine into the cells. They also confirmed that ADI-PEG 20 alone decreases ribonucleotide reductase M2 (RRM2), which results in decreased gemcitabine metabolism, thus increasing intracellular gemcitabine levels. Taken together, these dual interactions result in enhanced intracellular gemcitabine levels by 2 mechanisms, and enhanced gemcitabine toxicity.
This phase 3 trial will lower the dose of chemotherapy for smooth muscle sarcoma with the goal of reducing the side effects of chemotherapy while maintaining efficacy.
Phase 3

Phase 1/2

Glioblastoma

Drug: Pegargiminase (ADI‑PEG 20) + Temozolomide (TMZ) and Radiotherapy
Lead Institute: Taiwan Linkou Chang Gung Memorial Hospital

GBM (Phase 1/2)

Phase I/II Trial of ADI‑PEG 20 plus Radiotherapy and Temozolomide in Subjects with Newly Diagnosed Glioblastoma Multiforme (GBM)

This Phase I/II trial is a global, multi-center, randomized, double-blind, placebo-controlled study of ADI-PEG 20 versus placebo in combination with Temozolomide and Radiation, a standard front-line therapy to enroll 100 patients. The primary endpoint is Overall Survival, and PFS will be examined based on investigators and assessments.

Global Coalition for Adaptive Research（GCAR; Phase 2/3）

The GBM AGILE platform is a new clinical trial platform approved by the U.S. FDA that can simultaneously evaluate multiple new brain cancer drugs and share control group patients. Moreover, the platform has signed contracts with major international hospitals and can recruit patients quickly.

Phase 1/2

Phase 2/3

Hepatic Cell Carcinoma

Drug: Pegargiminase (ADI-PEG 20)
Lead Institute: Taiwan Linkou Chang Gung Memorial Hospital

HCC (Phase 2/3)

A Randomized, Double-Blind, Multi-Center Study of ADI-PEG 20 with Patients with high concentrations of spermidine and hepatocellular carcinoma that cannot be surgically removed. Unresectable Hepatocellular Carcinoma (HCC)

This is a randomized, placebo-controlled,biomarker selected trial, with overall survival (OS) as the primary outcome measure. Subjects will be randomized (1:1) to Pegargiminase (ADI-PEG 20) or placebo, and remain on ADI-PEG 20 or placebo treatment until PD per RECIST 1.1 criteria. CT (or MRI scan) will be performed at baseline and every 12 weeks. All subjects will receive best supportive care.
Phase 2/3

Phase 1

Acute Myeloid Leukemia

Drug: Pegargiminase (ADI-PEG 20)+ Venetoclax and Azacitidine
Lead Institute: MD Anderson Cancer Center

AML (Phase 1)

Phase IA/B Combination Study of ADI‑PEG 20, Venetoclax and Azacitidine in Patients with Acute Myeloid Leukemia (AML)

This is an open-label, single arm, phase 1 study of Pegargiminase in combination with Venetoclax and Azacitidine, a standard front-line therapy, for patients with AML. In addition to assessing the safety and tolerability of combining Pegargiminase and Venetoclax and Azacitidine, this study also intends to explore the antitumor effect of this combination in AML.
Phase 1

Phase 2

Nonalcoholic Steatohepatitis (NASH)

Drug: Pegargiminase (ADI-PEG 20)

Lead Institute: Taiwan Linkou Chang Gung Memorial Hospital

NASH (Phase 2)

A randomized, double-blind, multicenter phase 2A clinical trial comparing ADI-PEG 20 with placebo in patients with nonalcoholic steatohepatitis

This is a phase II, randomized, double-blind, multicenter clinical trial using ADI-PEG 20 versus placebo in the treatment of patients with nonalcoholic steatohepatitis. The primary objective of the trial was to assess changes in liver fat between baseline and week 24.
Phase 2
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