SystImmune Begins Global Trial for Iza-Bren in Breast Cancer, Triggers $250M Milestone from BMS
Clinical-stage biotech company SystImmune has dosed the first patient in a global registrational Phase 2/3 trial for its experimental cancer therapy izalontamab brengitecan (iza-bren), marking a major milestone in its partnership with Bristol Myers Squibb (NYSE: BMY).
The trial, IZABRIGHT-Breast01 (NCT06926868), is evaluating iza-bren in previously untreated triple-negative breast cancer (TNBC) patients who are ineligible for anti-PD(L)1 therapies. The milestone triggers a $250 million payment from Bristol Myers Squibb under the terms of their 2023 exclusive licensing agreement.
SystImmune is also eligible for up to $250 million in additional near-term milestones and up to $7.1 billion in future payments tied to development, regulatory, and sales achievements—making it one of the largest ADC-related biotech deals to date.
Iza-bren is a potential first-in-class bispecific antibody-drug conjugate (ADC) that targets EGFR and HER3 and delivers a topoisomerase 1 inhibitor payload. It is being developed in China by SystImmune’s parent company, Biokin, and co-developed globally with Bristol Myers Squibb.
“This milestone marks a significant step forward in the global clinical development of iza-bren,” said Dr. Yi Zhu, Chairman of SystImmune. “We are encouraged by the progress and Bristol Myers Squibb’s commitment to the program.”
SystImmune CEO Dr. Jie D’Elia added that the $250 million payment will further strengthen the company’s financial position and accelerate development of its broader ADC portfolio, which includes ongoing trials in lung and bladder cancers.
Iza-bren has also received Breakthrough Therapy Designation from the U.S. FDA for EGFR-mutated non-small cell lung cancer, reinforcing its potential across multiple solid tumor types.
The IZABRIGHT-Breast01 trial adds to a growing pipeline of global studies, signaling SystImmune’s rising profile in the ADC space as it targets unmet needs in hard-to-treat cancers.