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Initiates global Phase 2/3 study of izalontamab brengitecan (iza-bren) in triple negative breast cancer.
October 14, 2025
By: Kristin Brooks
Managing Editor, Contract Pharma
SystImmune, Inc., a clinical-stage biotechnology company, has dosed the first patient in the IZABRIGHT-Breast01 study, a global Phase 2/3 registrational study of izalontamab brengitecan (iza-bren) in triple negative breast cancer. This milestone triggers a one-time payment of $250 million by Bristol Myers Squibb, under the companies collaboration and license agreement.Â
SystImmune is eligible to receive up to an additional $250 million in contingent near-term payments and additional payments of up to $7.1 billion contingent upon the achievement of certain development, regulatory and sales performance milestones.
Iza-bren is a potential first-in-class bispecific topoisomerase 1 inhibitor-based antibody-drug conjugate (ADC) that targets both epidermal growth factor receptor (EGFR) and human epidermal growth factor receptor 3 (HER3). It is being developed by SystImmune’s parent company, Sichuan Biokin Pharmaceutical Co., Ltd. in China and jointly developed by SystImmune and BMS in territories outside of China.
“Together with Bristol Myers Squibb, we have made significant progress in developing iza-bren globally. We remain deeply committed to delivering this potentially transformative therapy to patients with triple negative breast cancer and other solid tumors,” said Dr. Jie D’Elia, CEO, SystImmune. “This $250 million milestone not only reflects the progress of our collaboration but also significantly reinforces our financial position, enabling us to accelerate the global development of our differentiated ADC portfolio.”
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