Global Coalition for Adaptive Research and Polaris Group Announce Commencement of ADI-PEG 20 in GBM AGILE Trial

Polaris Now Enrolling in GBM AGILE, Registrational Phase 2-3 Adaptive Platform Trial for Patients with Glioblastoma

Polaris lead biologic ADI-PEG 20 to be Evaluated Across Multiple International Trial Sites

LARKSPUR, Calif.–(BUSINESS WIRE)–#GBMAGILE–Global Coalition for Adaptive Research (LARKSPUR, CA) and Polaris Pharmaceuticals, Inc. (SAN DIEGO, CA), a subsidiary of Polaris Group (TWSE:6550)— The Global Coalition for Adaptive Research (GCAR) in collaboration with Polaris, today announced the activation of ADI-PEG 20 in GBM AGILE (Glioblastoma Adaptive Global Innovative Learning Environment – NCT03970447). GBM AGILE is a revolutionary patient-centered, adaptive platform trial for registration that evaluates multiple therapies for patients with newly-diagnosed and recurrent glioblastoma (GBM) – the deadliest form of brain cancer.

Polaris’ ADI-PEG 20 is entering the GBM AGILE trial, which initially opened in July 2019 and has screened over 1,500 patients to date. The investigational therapy will be evaluated at clinical trial sites in the U.S., Canada, Europe, and Australia.

The ADI-PEG 20 arm of GBM AGILE will be enrolling patients with newly-diagnosed unmethylated MGMT, newly-diagnosed methylated MGMT, and recurrent GBM. Dr. Macarena de la Fuente, Associate Professor of Neurology and Chief, Neuro-Oncology at University of Miami Sylvester Comprehensive Cancer Center and Dr. Nicholas Blondin, Assistant Professor of Clinical Neurology at Yale School of Medicine are serving as arm Principal Investigators for the ADI-PEG 20 arm.

“GBM AGILE is designed to maximize learning and rapidly identify effective therapies for patients with glioblastoma by simultaneously and dynamically evaluating the effects of multiple new drug candidates,” said Dr. Macarena de la Fuente. “We look forward to evaluating ADI‑PEG 20 in GBM AGILE. This investigational drug has the potential to support improved outcomes for GBM patients, who deserve better options for their care.”

“Glioblastoma is a deadly brain cancer with few effective treatment options. Patients are in desperate need of better treatment options,” said Dr. Nicholas Blondin. “With the addition of ADI-PEG 20 to GBM AGILE, a global clinical trial for newly diagnosed and recurrent GBM patients, we are able to offer GBM patients access to the latest and most promising investigational therapies.”

GBM AGILE is an international, innovative platform trial designed to more rapidly identify and confirm effective therapies for patients with glioblastoma through response adaptive randomization and a seamless phase 2/3 design. The trial, conceived by over 130 key opinion leaders, is conducted under a master protocol, allowing multiple therapies or combinations of therapies from different pharmaceutical partners to be evaluated simultaneously. With its innovative design and efficient operational infrastructure, data from GBM AGILE can be used as the foundation for a new drug application (NDA) and biologics license application (BLA) submissions and registrations to the FDA and other health authorities.

ADI-PEG 20 is a biologic being developed by Polaris Group to treat various cancers. Arginine is an amino acid that is essential for protein synthesis and survival of cells. Some cancer cells become dependent upon the external supply of arginine to survive and grow. ADI-PEG 20 is designed to deplete the external supply of arginine, which causes arginine-dependent cancer cells to die while leaving the patient’s normal cells unharmed. Multiple cancers have been reported to have a high degree of arginine dependency. ADI-PEG 20 has been tested in more than twenty clinical trials globally for a wide variety of cancers, including hepatocellular carcinoma, mesothelioma, pancreatic cancer, non-small cell lung cancer, melanoma, acute myeloid leukemia, and others.

“We are excited to initiate the evaluation of ADI-PEG 20 in GBM AGILE, a cutting-edge adaptive trial designed to rapidly identify whether drugs such as ADI-PEG 20 can bring benefit to patients with glioblastoma,” said Howard Chen, Chairman and CEO, Polaris Group. “We have seen encouraging data with ADI-PEG 20 in previous clinical studies, and look forward to rapidly advancing the development of ADI-PEG 20 for the treatment of glioblastoma, a devastating and deadly disease with a critical and unmet need for more effective treatments.”

About Global Coalition for Adaptive Research (GCAR)

Global Coalition for Adaptive Research (GCAR) is a 501(c)(3) non-profit corporation uniting biotech/pharma, physicians, clinical researchers, advocacy and philanthropic organizations, health authorities, and other key stakeholders in healthcare. Together, GCAR and its partners expedite the discovery and development of treatments for patients with rare and deadly diseases. GCAR leads and implements innovative and complex trials including master protocols and platform trials and is the sponsor of GBM AGILE, a patient-centric adaptive platform trial for patients with GBM – the deadliest of malignant primary brain tumors. Key advocacy partners for the GBM AGILE trial effort include the National Brain Tumor Society, National Foundation for Cancer Research, Asian Fund for Cancer Research, and Cure Brain Cancer Foundation, non-profit organizations working together to provide philanthropic support and assist in communicating with patients and families. We invite others to support this innovative approach to brain tumor treatment development. To learn more about GCAR and its initiatives, visit gcaresearch.org.

About Polaris Group

Polaris Group is a multinational biotechnology company specializing in the research and development of novel pharmaceuticals to treat cancer. The company’s lead therapeutic, ADI‑PEG 20, is a novel biologic in late-stage clinical development. It has been tested in more than twenty clinical trials globally for a wide variety of cancers, including hepatocellular carcinoma, mesothelioma, pancreatic cancer, non-small cell lung cancer, melanoma, acute myeloid leukemia and others. As a fully integrated company, Polaris is engaged in applying protein structure-based drug design technology to develop novel drug candidates for cancers, conducting clinical studies at top-tier cancer centers worldwide, and manufacturing all clinical materials at its cGMP facility in northern California. For additional information please visit polarispharma.com

Contacts

Global Coalition for Adaptive Research

Rachel Rosenstein-Sisson

[email protected]

Polaris Group

Gina Lee

[email protected]