TAIPEI, Taiwan and SAN DIGEO, CA, USA I November 16, 2023 I Polaris Group (The Company, TWSE:6550), today announced that the Company has initiated the rolling submission of its Biologic License Application (BLA) for ADI-PEG 20 to the U.S. Food and Drug Administration (FDA) for the systemic treatment of patients with malignant pleural mesothelioma with non-epithelioid histology, in combination with a platinum agent and pemetrexed. This submission is based on the results of the successful phase 3 trial of ADI-PEG 20 in combination with a platinum agent and pemetrexed which met both its primary and secondary objectives for progression free survival and overall survival. The rolling submission process allows for the submission of individual modules of the BLA as they are completed, which can streamline the regulatory review process and may expedite the potential approval timeline.

This initial submission to the U.S. FDA includes the nonclinical and clinical portions of the BLA for ADI-PEG 20, with plans to finalize the remaining chemistry, manufacturing, and controls components in the coming months. When the final portion of the BLA is submitted, Polaris Group will actively seek priority review status for this BLA, which, if granted, could expedite the regulatory review process.

Dr. John Bomalaski, Executive Vice President of Medical Affairs at Polaris Group, commented, “Our clinical trials have demonstrated promising results, with ADI-PEG 20 showing statistically significant potential to address the medical needs of patients with malignant pleural mesothelioma. Our comprehensive development program is designed to provide robust data that supports the FDA’s review of our BLA.”

Howard Chen, CEO and Chairman of Polaris Group, added, “We are fully committed to addressing the urgent medical needs of patients facing malignant pleural mesothelioma. Today’s submission brings us one step closer to expanding treatment options for patients impacted by MPM in the U.S. If approved by the FDA, this therapy would be a welcome addition to treatment options for patients and an important step forward for our work in hard-to-treat cancers. We look forward to collaborating closely with the FDA throughout the review process.”

About ADI-PEG 20 and Its Potential for Malignant Pleural Mesothelioma

ADI-PEG 20 is a novel therapy that holds promise in the treatment of malignant pleural mesothelioma, a rare and aggressive form of cancer. Polaris Group’s development program for ADI-PEG 20 is focused on demonstrating its safety and efficacy in addressing the pressing medical needs of patients facing this challenging condition. Three Phase 3 clinical studies with ADI-PEG 20 in other hard to treat cancers are currently ongoing.

About Malignant Pleural Mesothelioma:

Malignant pleural mesothelioma is a highly aggressive and challenging form of cancer that affects the lining of the lungs. It is primarily caused by exposure to asbestos and is associated with poor prognosis and limited treatment options.

About Polaris Group

Polaris Group is a biopharmaceutical company dedicated to pioneering advanced therapies, primarily focusing on metabolic related diseases. Our lead drug candidate, Pegargiminase (ADI‑PEG 20), is presently advancing through the BLA-enabling stage and clinical development. Pegargiminase is designed to disrupt cancer cell metabolism, providing a novel approach to treating a wide range of cancers heavily influenced by metabolic pathways. Our mission is to revolutionize the treatment of complex diseases like cancer by concentrating on their metabolic foundations, ultimately striving to enhance patient outcomes globally.

SOURCE: Polaris Group