SystImmune, Inc. and Bristol Myers Squibb Announce First Global Phase I Results of Iza-bren

*October 2025*

REDMOND, Wash. and PRINCETON, N.J., Oct. 17, 2025 /PRNewswire/ — SystImmune Inc. (SystImmune), a clinical-stage biotechnology company, and Bristol Myers Squibb (NYSE: BMY) today announced the oral presentation of the first disclosure of the safety and efficacy data from the global phase I US-Lung-101 study (NCT05983432) of iza-bren (BL-B01D1), a potentially first-in-class EGFR x HER3 bispecific antibody-drug conjugate (ADC), at the European Society for Medical Oncology (ESMO) Congress 2025 in Berlin, Germany. Iza-bren is jointly developed by SystImmune and Bristol Myers Squibb under a collaboration and exclusive license agreement in territories outside of Mainland China. In August 2025, iza-bren was granted breakthrough therapy designation by U.S. FDA for patients with previously treated EGFR-mutated NSCLC based on the data from China studies and this global study.

This study evaluated the safety and efficacy of iza-bren in global patients with heavily pre-treated metastatic or unresectable advanced non-small cell lung cancer (NSCLC) and other solid tumors. At the data cut-off (DCO) of July 23, 2025, iza-bren has demonstrated:

Promising antitumor activity in heavily pre-treated patients across multiple tumor types, including EGFR mutant and wildtype NSCLC
Manageable safety profile, with hematologic adverse events effectively managed by standard medical measures, and no interstitial lung disease was observed