SOTIO Reveals Promising Preclinical Data on SOT109 for Colorectal Cancer
SOTIO Biotech, a clinical-stage biopharmaceutical company owned by PPF Group, has unveiled groundbreaking preclinical data for SOT109, a novel antibody-drug conjugate (ADC) designed to target cadherin-17 (CDH17). The data, presented at the 15th World ADC London 2025 from March 3-6 at Novotel London West, highlight the promising therapeutic potential and favorable tolerability of SOT109 across multiple disease models. These findings position SOT109 as a potentially best-in-class treatment for colorectal cancer (CRC) and other gastrointestinal (GI) cancers.
“We are thrilled to present the first preclinical data on SOT109, which marks a significant step forward in the treatment of colorectal and other GI malignancies,” said Martin Steegmaier, Ph.D., Chief Scientific Officer of SOTIO. “CDH17 has long been recognized as an ideal target for therapeutic intervention. However, previous non-ADC and ADC approaches have faced significant hurdles.
Our innovative design overcomes these challenges by incorporating cutting-edge linker-payload technology and an optimized antibody backbone to enhance both efficacy and tumor selectivity. The preclinical data show that SOT109 effectively kills tumor cells while maintaining an excellent safety profile, offering a high therapeutic index. We believe this represents a major advancement in ADC development for GI cancers, and we are excited to file an Investigational New Drug (IND) application for SOT109 in Q2 2026.”
Targeting CDH17 for GI Cancers
CDH17 is a highly promising target for cancer treatment, as it is overexpressed in more than 90% of colorectal cancers and is also found abundantly in other GI cancers, including gastric, pancreatic, and esophageal cancers. Importantly, CDH17 expression in normal adult tissues is predominantly confined to the GI tract, significantly reducing the risk of off-target toxicity that is often seen in cancer treatments.
Because CDH17 is a transmembrane protein that is rapidly internalized by GI cancer cells, it is an ideal candidate for antibody-drug conjugate (ADC) technology, which allows for precise drug delivery directly to tumor cells. SOT109 is a fully human, highly specific ADC designed to bind to CDH17 with exceptional specificity and internalization properties, ensuring that the therapeutic agent is delivered directly to the cancer cells while minimizing damage to surrounding healthy tissues.
The SYNtecan E™ Linker-Payload System
SOT109 utilizes Synaffix’s clinically validated ADC platform, which incorporates the proprietary SYNtecan E™ linker-payload system. This system delivers a highly potent exatecan payload (DAR=4) to tumor cells. Exatecan is a chemotherapy agent with strong anti-tumor activity that is known for its ability to overcome resistance mechanisms typically seen with other therapies. The high cell permeability of the exatecan payload also enhances the bystander effect, allowing for the destruction of nearby tumor cells that may not have been directly targeted, further improving its therapeutic potential.
For the treatment of colorectal cancer, SOT109’s exatecan payload is expected to exhibit superior activity compared to other ADC payloads, with reduced susceptibility to resistance and enhanced cytotoxic effects, making it a promising candidate for clinical development.
Preclinical Data
The preclinical data presented at the World ADC London conference show that SOT109 demonstrates robust anti-tumor activity across multiple mouse xenograft models, including cases where complete responses were observed. Additionally, SOT109 showed favorable tolerability in an exploratory mouse study, even at doses as high as 150 mg/kg. These findings suggest that the ADC can be administered at high doses without significant toxicity, making it a promising candidate for further development.
In a toxicity study conducted in non-human primates (NHPs), SOT109 exhibited a favorable therapeutic index, meaning that the drug effectively targets tumor cells while minimizing harmful effects on healthy tissues. This reinforces the potential of SOT109 to be a transformative therapy for GI cancers, particularly colorectal cancer, where new and more effective treatments are urgently needed.
SOTIO Biotech’s Commitment to Cancer Treatment
SOTIO Biotech is dedicated to advancing the field of cancer immunotherapies by translating cutting-edge science into meaningful patient benefits. The company’s pipeline includes a range of mono- and bispecific ADC programs at various stages of preclinical development, alongside clinical-stage therapies like BOXR1030, a metabolically enhanced CAR-T cell therapy targeting GPC3-expressing tumors, and SOT201, a next-generation PD-1 targeting immunocytokine.
As a member of the PPF Group, SOTIO is committed to making a significant impact on the treatment of various cancers, including colorectal and other gastrointestinal cancers. With SOT109’s promising preclinical data, the company is poised to further develop this innovative ADC to provide a new and potentially more effective therapeutic option for patients with these challenging cancers.
The ongoing development of SOT109 represents a significant advancement in ADC technology, offering hope for improved treatment options for patients suffering from GI cancers. With further clinical testing, SOTIO aims to bring this promising therapy to market, providing new hope for patients with difficult-to-treat cancers.
