- Updated safety & efficacy in Locally Advanced or Metastatic Breast Cancer will be presented from a Ph1 clinical study evaluating iza-bren, an EGFRxHER3 bispecific topoisomerase inhibitor- based antibody-drug conjugate (ADC)
REDMOND, Wash., May 9, 2025 -- SystImmune, Inc. (SystImmune), a clinical-stage biotechnology company, today announced that one abstract on izalontamab brengitecan (iza-bren), a potentially first-in-class EGFRxHER3 bispecific antibody drug conjugate (ADC) will be presented at the European Society for Medical Oncology (ESMO) Breast Cancer 2025 Annual Congress taking place May 14 – May 17 in Munich, Germany. Iza-bren is being jointly developed by SystImmune and Bristol Myers Squibb under a collaboration and exclusive license agreement.
Data will be presented at the meeting from an ongoing Ph1 clinical trial of iza-bren in patients with locally advanced or metastatic HER2- Breast Cancer. Additional subgroup analysis in previously disclosed data at SABCS 2024 shows encouraging efficacy for iza-bren across all HER2 levels in HER2- Breast Cancer patients including HER2 0 patients. These data highlights continued progress in iza-bren clinical development and builds upon the previously reported clinical data in breast cancer patients at SABCS in 2024.
"These data continue to support our conviction that iza-bren demonstrates strong clinical efficacy across a wide variety of tumors such as breast cancer including HER2 negative breast cancer with a manageable safety profile," said Jonathan Cheng, M.D., CMO of SystImmune. "This positions iza-bren as an important therapeutic option that may address the unmet medical needs of patients with limited treatment options. We are committed to advancing this therapy through clinical trials, exploring its potential not only as a monotherapy but also in combination with other agents, so as to improve outcomes for cancer patients globally."
Details on the presentations at ESMO Breast are below:
Phase I study of iza-bren (BL-B01D1), an EGFR x HER3 Bispecific Antibody-drug Conjugate (ADC), in Patients with Locally Advanced or Metastatic Breast Cancer (BC)
Presentation No: 302MO
Session Title: Mini Oral Session 2
Speaker: Yiqun Du (Shanghai, China)
Session Date & Time: Friday, May 16th, 2025, 8:20 AM-10:10 AM CEST
About iza-bren
The company is developing iza-bren, a bispecific antibody-drug conjugate (ADC) that targets both EGFR and HER3. These proteins are highly expressed in most epithelial tumors. The tetravalent iza-bren has two binding domains for distinct Growth Factor Receptors that drive cancer cell proliferation and survival. Iza-bren blocks EGFR and HER3 signals to cancer cells, reducing proliferation and survival signals. Upon antibody mediated internalization, iza-bren is trafficked to cancer cell lysosomes and liberates its therapeutic payload that induces genotoxic stress activating pathways leading to cancer cell death.
About SystImmune
SystImmune is a clinical-stage biopharmaceutical company located in Redmond, WA. It specializes in developing innovative cancer treatments using its established drug development platforms, focusing on bi-specific, multi-specific antibodies, and antibody-drug conjugates (ADCs). SystImmune has several assets in various stages of clinical trials for solid tumor and hematologic indications. Alongside ongoing clinical trials, SystImmune has a robust preclinical pipeline of potential cancer therapeutics in the discovery or IND-enabling stages, representing cutting-edge biologics development.
Forward-Looking Statements
Any research and development information provided by SystImmune is intended for general information purposes only. Such information is not intended to provide complete medical information. We do not offer patient-specific treatment advice and if you have medical conditions, please see your medical doctor or healthcare provider.
This press release may contain forward-looking statements with the meaning of Section 27A of the Securities Act of 1933, as amended, Section 21E of the Securities Exchange Act of 1934, and the Private Securities Litigation Reform Act of 1995, which reflects the expectations regarding the company's goals, strategies, results of operations, performance, business prospects, and opportunities, including but not limited to the ability to gain Investigational New Drug status for the resulting new product and the ability to develop a successful formulation. Terms such as "anticipates," "believes," "expects," "estimates," "could," "intends," "may," "plans," "potential," "projects," "will," "would" and other similar expressions, or the negative of these terms, are generally indicative of forward-looking statements.
While SystImmune, Inc. believes that expectations expressed in the forward-looking statements are based on the company's reasonable assumptions and beliefs in light of the information available to the company at the time such statements are made, it cannot give assurance that such forward-looking statements will prove to have been correct. Such forward-looking statements are not fact and are subject to uncertainties and other factors that could cause actual results to differ materially from such statements. We undertake no obligation to update any forward-looking statements contained in this press release to reflect events or circumstances occurring after its date or to reflect the occurrence of unanticipated events.
For additional information about the company, please visit https://systimmune.com/.
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