SystImmune, Inc. to Present New Data from Oncology Programs at the American Society of Clinical Oncology (ASCO) Annual Meeting in June 2023

  • Results from early-stage clinical trials of BL-B01D1, the bi-specific antibody-drug conjugate (ADC) targeting EGFR and HER3, will be presented.
  • Results from Phase II clinical trials of izalontamab, the bi-specific antibody targeting EGFR and HER3, will be presented.
  • Design and Rationale of the Trial in Progress of the first tetra-specific T cell engager, emfizatamab, will be presented.

REDMOND, Wash., May 1, 2023 /PRNewswire/ -- Systimmune, Inc. (SystImmune) announced today that it will present clinical data from its lead programs at the ASCO Annual Meeting 2023 in Chicago in June. The clinical results to be presented will be from trials involving patients with several solid tumor types.

"Through our commitment to innovative research, we are pleased to have multiple modalities selected to showcase our groundbreaking pipeline at this year's ASCO meeting. Our focus on advancing the field of oncology is reflected in the clinical data that our distinguished clinical investigators will present, and we are excited to share our progress toward improving patient outcomes with the scientific community," said Yi Zhu, Ph.D., President & CEO of SystImmune.

"We are thrilled to be presenting our clinical data at the upcoming ASCO Annual Meeting, which includes our first-in-class bi-specific antibody-drug conjugate. The results of our trials highlight the potential of our innovative therapies to address unmet needs in a variety of solid tumor types. At SystImmune, we remain committed to advancing the field of oncology and expanding treatment options to benefit patients," said Martin Olivo, M.D., CMO of SystImmune.

Key highlights of data selected by ASCO include

Molecule Name

Abstract Title

Abstract Number/ Presentation Details


BL-B01D1, a first-in-class EGFRxHER3 bispecific antibody-drug conjugate (ADC), in patients with locally advanced or metastatic solid tumor: Results from a first-in-human phase 1 study.

Abstract #3001

Oral Presentation:

Monday, June 5, 8:00 -11:00 am CDT


SI-B001 plus chemotherapy in patients with locally advanced or metastatic EGFR/ALK wild-type non-small cell lung cancer: A phase II, multicenter, open-label study.

Abstract #9025

Poster Discussion Session

Poster Available: Sunday, June 4, 8:00 - 11:00 am CDT


Sunday, June 4, 4:30 - 6:00 pm CDT


Results from two phase II studies of SI-B001, an EGFR×HER3 bispecific antibody, with/without chemotherapy in patients (pts) with recurrent and metastatic head and neck squamous cell carcinoma (HNSCC).

Abstract #6037

Poster Available:
Monday, June 5, 1:15 - 4:15 pm CDT


GNC-038, A tetra-specific antibody, in patients with R/R non-Hodgkin lymphoma or acute lymphoblastic leukemia: A phase 1 study design and rationale.

Abstract #TPS2668

Poster Available:

Saturday, June 3, 8:00 -11:00 am CDT


SI-B003 (PD-1/CTLA-4) in patients with advanced solid tumors: A phase I study.

Abstract#: e14668


SystImmune Programs Profiled at ASCO

About SI-B001

The company has developed SI-B001, also known as izalontamab, an EGFR×HER3 bispecific antibody that can target both EGFR and HER3. The bi-specific SI-B001 is built on a tetravalent platform having two binding domains for distinct Growth Factor Receptors that drive cancer cell proliferation and survival. The SI-B001 primary mechanism of action is the blocking of EGFR and HER3 signals to cancer cells, and secondarily, through a wt FC receptor mediating innate immune effector functions toward the cancer cells.

About BL-B01D1

The company is developing 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 BL-B01D1 has two binding domains for distinct Growth Factor Receptors that drive cancer cell proliferation and survival. Inheriting the SI-B001 mechanisms of action, BL-B01D1 blocks EGFR and HER3 signals to cancer cells, reducing proliferation and survival signals. Upon antibody mediated internalization, BL-B01D1 is trafficked to cancer cell lysosomes and liberates its therapeutic payload that induced genotoxic stress activating pathways leading to cancer cell death.

About GNC-038

The company is developing GNC-038, also known as emfizatamab, the world's first anti-tumor tetra-specific antibody drug in human trials. The GNC-038, octavalent, tetra-specific T cell engager is designed to target CD19 expressing B cell malignancies. The GNC-038 molecule can bind CD3 and CD19 to redirect T cell cytotoxicity toward specified cancer indications defined by CD19 expression. The molecule can also redirect T cell cytotoxicity toward PDL1 high-expressing cells, representing its potential to convert cancer cell adaptive resistance into drug sensitivity. The GNC-038 can also engage 41-BB in a non-cytolytic fashion, transducing an educational signal to T cells that lead to increased functionality throughout dosing cycles.

About SI-B003:

The company is developing SI-B003, also known as danvilostomig, a tetravalent molecule having two binding domains along the T cell checkpoint axis, PD-1, and CTLA-4. The primary targets for this molecule are exhausted tumor-specific T cells, which demonstrate enhanced functionality upon treatment with PD-1 and CTLA-4 blocking antibodies, restoring their anti-tumor activity. By combining bi-valency with bi-specificity in the tetravalent format, the dual checkpoint molecule utilizes avidity and bi-specificity to improve anti-cancer immune cell function. The specificity enhancement both synergistically enhances and expands the breadth of immune cell activity that is diminished in cancer patients.

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.

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