DEM BioPharma to Present First-in-Class ADC DEM301 for Gastrointestinal Cancers at ASCO GI 2026
核心洞察
DEM BioPharma (搜索) will present preclinical data for DEM301 (搜索), a first-in-class bifunctional antibody drug conjugate targeting the novel plasma membrane protein DEM-TXX (搜索) overexpressed in colorectal and other gastrointestinal malignancies (搜索).
The company's preclinical studies demonstrate potent and durable single-agent anti-tumor efficacy in colorectal and GI tumor models with a favorable safety profile in humanized mouse models.
DEM301 (搜索) features a dual mechanism of action designed to directly kill tumor cells while engaging immune-mediated mechanisms, with Phase 1a/1b clinical trials planned for the second half of 2026.
DEM BioPharma (搜索) will present preclinical data for its novel antibody drug conjugate DEM301 (搜索) at the 2026 ASCO Gastrointestinal Cancers Symposium, marking the first public disclosure of the company's first-in-class therapeutic targeting a previously undisclosed plasma membrane protein in gastrointestinal malignancies (搜索).
The Cambridge-based biopharmaceutical company announced that DEM301 (搜索) targets DEM-TXX (搜索), a novel plasma membrane-associated glycoprotein that is overexpressed in colorectal cancer (搜索) and several other gastrointestinal malignancies (搜索). According to the company, DEM-TXX plays roles in cell adhesion and myeloid cell suppression, with its expression negatively correlated with disease progression.
Novel Target Discovery and Mechanism
DEM-TXX (搜索) emerged from the company's proprietary CRISPR-based functional genomics screening platform, which enables identification of unique strategies to attack tumor cells and the tumor microenvironment. CEO Nenad Grmusa explained that the target "appears to contribute to immune suppression in GI cancers" and was validated by DEM BioPharma (搜索) as having potential significance in tumor biology.
"DEM301 (搜索) was purpose-built to translate that biology into a differentiated ADC designed with a dual mechanism of action to directly kill tumor cells while engaging immune-mediated mechanisms," Grmusa stated.
Bifunctional ADC Design
DEM301 (搜索) is composed of an afucosylated monoclonal antibody directed against DEM-TXX (搜索) and conjugated to a clinically validated linker-payload. The molecule is designed to selectively target tumor cells expressing DEM-TXX while leveraging both direct cytotoxic delivery and immune-mediated mechanisms of action.
The bifunctional design represents an approach to combine traditional ADC cytotoxicity with immune system engagement, potentially offering advantages over conventional single-mechanism therapies.
Preclinical Efficacy and Safety
The preclinical data to be presented at ASCO GI will highlight potent and durable single-agent anti-tumor efficacy in preclinical models of colorectal and other GI tumors. The company reports a favorable safety profile in a humanized DEM-TXX (搜索) mouse model, supporting advancement toward clinical development.
These findings support the therapeutic potential of targeting DEM-TXX (搜索) in gastrointestinal malignancies (搜索) and provide the foundation for the planned clinical program.
Clinical Development Timeline
DEM BioPharma (搜索) is currently advancing DEM301 (搜索) through preclinical pharmacology and toxicology studies while initiating chemistry, manufacturing, and controls (CMC) process development and manufacturing development. The company has initiated pre-IND studies to support a planned Phase 1a/1b clinical trial expected to begin in the second half of 2026.
The poster presentation will take place on January 10, 2026, during Poster Session C: Cancers of the Colon, Rectum, and Anus, with Sarah Carden, PhD, from DEM BioPharma (搜索) serving as the presenter.