- Initial safety & efficacy in patients with Small Cell Lung Cancer (SCLC) and Non-Small Cell Lung Cancer (NSCLC) with Driver Genomic Alterations (GA) outside of Classic EGFR Mutations will be presented from clinical studies evaluating iza-bren, an EGFRxHER3 bispecific topoisomerase inhibitor- based antibody-drug conjugate (ADC)
REDMOND, Wash., May 23, 2025 -- SystImmune, Inc. (SystImmune), a clinical-stage biotechnology company, today announced that two abstracts on izalontamab brengitecan (iza-bren), a potentially first-in-class EGFRxHER3 bispecific antibody drug conjugate (ADC) will be presented at the American Society of Clinical Oncology (ASCO) 2025 Annual Meeting taking place May 30 – June 3 in Chicago. Iza-bren is being jointly developed by SystImmune and Bristol Myers Squibb under a collaboration and exclusive license agreement.
Expanded results from clinical trials of iza-bren will include data from patients with advanced stages of Small Cell Lung Cancer and Non-Small Cell Lung Cancer with driver genomic alterations (GA) outside of classic EGFR mutations and having multiple lines of prior therapies. The data to be presented at ASCO highlights continued progress in iza-bren clinical development and builds upon the previously reported clinical data in lung and breast cancer patients at ASCO, ESMO, and SABCS in 2023 and 2024.
"Recent data have bolstered our confidence in iza-bren's safety profile while highlighting its encouraging efficacy across tumors that have been difficult to treat," stated Jonathan Cheng, M.D., CMO of SystImmune. "Iza-bren emerges as a promising therapeutic option, potentially fulfilling the unmet need of patients with few treatment alternatives. Our commitment to advancing this therapy through a series of comprehensive clinical trials remains steadfast, as we explore its potential both as a standalone treatment and in combination with other agents to improve cancer patient outcomes globally."
Details on the presentations at ASCO 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 Non-Small Cell Lung Cancer (NSCLC) with Driver Genomic Alterations (GA) outside of Classic EGFR Mutations
Session Title: Developmental Therapeutics—Molecularly Targeted Agents and Tumor Biology
Abstract: 3001
Speaker: Yunpeng Yang (Guangzhou, China)
Session Date & Time: Friday, May 30th, 2025, 2:45 PM-5:45 PM CDT
Phase I study of iza-bren (BL-B01D1), an EGFR x HER3 Bispecific Antibody-drug Conjugate (ADC), in Patients with Locally Advanced or Metastatic Small Cell Lung Cancer (SCLC)
Session Title: Developmental Therapeutics—Molecularly Targeted Agents and Tumor Biology
Abstract: 3002
Speaker: Yan Huang (Guangzhou, China)
Session Date & Time: Friday, May 30th, 2025, 2:45 PM-5:45 PM CDT
About iza-bren
The company is developing iza-bren (BL-B01D1), 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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