On May 1, 2023 Systimmune, Inc. (SystImmune) reported that it will present clinical data from its lead programs at the ASCO (Free ASCO Whitepaper) Annual Meeting 2023 in Chicago in June (Press release, SystImmune, MAY 1, 2023, View Source [SID1234630798]). The clinical results to be presented will be from trials involving patients with several solid tumor types.
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"Through our commitment to innovative research, we are pleased to have multiple modalities selected to showcase our groundbreaking pipeline at this year’s ASCO (Free ASCO Whitepaper) 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 (Free ASCO Whitepaper) 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 (Free ASCO Whitepaper) include
Molecule Name
Abstract Title
Abstract Number/ Presentation Details
BL-B01D1
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
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
Discussion:
Sunday, June 4, 4:30 – 6:00 pm CDT
SI-B001
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
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
SI-B003 (PD-1/CTLA-4) in patients with advanced solid tumors: A phase I study.
Abstract#: e14668
online
SystImmune Programs Profiled at ASCO (Free ASCO Whitepaper)
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.