English

Polaris Group Initiates Rolling Submission of Biologic License Application (BLA) for ADI-PEG 20 with U.S. FDA to Treat Malignant Pleural Mesothelioma

TAIPEI, Taiwan and SAN DIEGO, Calif., Nov 17, 2023 – 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.

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

LARKSPUR, Calif.–(BUSINESS WIRE)–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).

Polaris Group Appoints Ken Chang, Ph.D., as Chief Strategy Officer and Hugh Yu, Ph.D., as Chief Operating Officer

TAIPEI, Taiwan and SAN DIEGO, Calif., June 13, 2023 — Polaris Group (TWSE: 6550), a multinational biopharmaceutical company focused on research and development of novel biological drugs for cancer and other metabolic diseases, is proud to announce the appointment of Ken Chang, Ph.D., as Chief Strategy Officer and Hugh Yu, Ph.D., as Chief Operating Officer.

Polaris Group’s Affiliate Nanotein Technologies Launches a Revolutionary NK Cell Activation and Expansion Reagent

TAIPEI, Taiwan and VACAVILLE, Calif., June 07, 2023— Polaris Group (TWSE: 6550), a multinational biopharmaceutical company focused on research and development of novel biological drugs for cancer and other metabolic diseases, today announced that Polaris Group’s affiliate, Nanotein Technologies, has just launched GROW-NK, a novel Natural Killer (NK) cell activation and expansion reagent.

Polaris Group Presents Positive Phase 2/3 data for ADI-PEG 20, First-in-Class Arginine Depletion therapy in Patients with Malignant Pleural Mesothelioma at AACR Annual Meeting 2023

TAIPEI, Taiwan and SAN DIEGO, Calif., April 16, 2023 — Polaris Group (TWSE: 6550), a multinational biopharmaceutical company focused on research and development of novel biological drugs for cancer and other metabolic diseases, today presented data from its Phase 2/3 ATOMIC Study, a global, multi-center, randomized, double-blind, placebo-controlled trial of ADI-PEG 20 in combination with Pemetrexed and Cisplatin in patients with unresectable Malignant Pleural Mesothelioma (MPM) with biphasic or sarcomatoid histology.

Scroll to Top
This site is registered on wpml.org as a development site.