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In vitro diagnostic assays
Proteoglycans: biomarkers with predictive and prognostic potential
Proteoglycans are proteins modified with glycosaminoglycans such as CS. Found on the surface of cancer cells and within the extracellular matrix, these molecules play a key role in supporting tumor progression and metastasis.
We have shown that several oncogenic proteoglycans – including CD44, GPCs, and SDCs– are distinctly modified with oncofetal CS in multiple cancers. We have developed an ELISA-based assay using rVAR2 or Vartumabs, achieving high sensitivity (0.92) and specificity (0.95). This assay enabled early-stage cancer detection (stage 1) in colorectal cancer patients, with detection levels comparable to the Fecal immunochemical test (FIT). Expanding beyond colorectal cancer, we have adapted this assay for multi-cancer testing and validating its applicability for other body fluids such as bladder cancer detection using urine samples.
Expanding the clinical use of Circulating Tumor Cells
Circulating tumor cells (CTCs) are released from tumor sites into the bloodstream and represent the primary mechanism for the formation of metastasis. Standard markers for capture and/or detection of CTCs are of low abundance and with limited cancer specificity. This results in reduced retrieval and/or identification of true CTCs.
Using rVAR2 and Vartumabs, we can efficiently capture and detect a CTCs of both epithelial and mesenchymal origins. Additionally, the surface display of oncofetal CS allows for further downstream analysis of viable CTCs, providing a valuable tool for advanced treatment monitoring and the overall management of metastatic disease. We capture live CTCs with 2-3x higher sensitivity and specificity than traditional markers and have shown superior performance within prostate cancer where CTCs are a prognostic biomarker but also in emerging indications such as melanoma, glioma, and pancreatic cancer.
Tissue Staining: Complementing current practices
Histopathological analysis of tumor biopsies remains the gold standard for cancer diagnostics and guiding treatment decisions in the form of companion diagnostics (CDx).
Oncofetal CS, which manifests early in tumorigenesis and is present on both cancer cells and in the surrounding tumor stroma, offers a significant advantage for cancer detection.We are supporting VAR2 Pharmaceuticals therapeutic efforts by developing an IHC CDx assay using Vartumabs to guide treatment decisions.We are also developing IHC assays using Vartumabs to identify oncofetal CS at the earliest stages of cancer progression. These assays will seamlessly integrate with current pathology workflows, offering the potential for earlier and more accurate diagnoses, thereby improving treatment outcomes.
Our Pipeline: Pushing forward a first-in-class approach
We have obtained solid evidence of the potential efficacy and safety of Vartumabs as a cancer targeting platform. Intravenous injection of Vartumabs into animal models demonstrates high tumor specificity with no apparent off target effects. This indicative safety is supported by repeat high dose IV injections of antibody drug conjugates showing no weight loss, change in blood panels or other adverse effects in several cancers and models, including in xenograft human lymphoma (Karpas), allograft murine colorectal carcinoma (CT26), and patient derived (PDX) Pancreatic (PDAC) and sarcoma mice models. Anti-CD3 fusions have a similar efficacy and safety profile in mouse models, with a dramatic effect on tumor growth and results in either complete stop of tumor growth or full tumor regression depending on the model.
Tumor burden and relative body weight evolution in mice cancer models for Lymphoma (Karpas 299) and murine colorectal carcinoma (CT26)
Phase 0: A First-in-Human Microdosing Study
Our first clinical study will start in Q3 2024, and for which we already achieved scale-up production milestones. This first trial will take the shape of nuclear imaging, first-in-human study with ~ 30 patients in a basket trial format. We expect this study to provide us with the pharmacokinetics and biodistribution of Vartumabs in patients with cancer, paving the way for efficacy trials.