On September, 30 2024 VAR2 Pharmaceuticals ApS (‘VAR2 Pharma’) reported the company has received regulatory approval for their first-in-human Phase 0 clinical trial (Press release, Var2 Pharmaceuticals, SEP 30, 2024, View Source [SID1234646933]). In this study, the safety, tolerability, and biodistribution of two zirconium-89 labeled single-chain variable Fragments (scFvs) will be evaluated using PET/CT molecular imaging. The Danish company VAR2 Pharma is collaborating with TRACER, a CRO specialized in molecular imaging trials. The study will be conducted in the Netherlands and patient recruitment will start next month.
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VAR2 Pharma’s antibodies ("Vartumabs") were shown to selectively bind tumors in preclinical studies and will now be tested for the first time in patients with various types of solid cancers. By including multiple cancer indications, this study aims to evaluate the safety, tolerability, and biodistribution of two Vartumabs.
The study, designed by TRACER CRO, will include 16 patients per compound. Each participant will be administered a microdose which has no therapeutic intent but is sufficient for PET imaging. An important secondary objective of this study is to identify which tumor indications show the best uptake to inform subsequent clinical studies. Showing tumor-specific binding in humans is expected to pave the way for the development of oncology therapeutics and diagnostics based on Vartumabs.
About oncofetal chondroitin sulfate
Oncofetal chondroitin sulfate is an unusually long sugar chain with a heavy sulfation pattern presenting as a secondary modification in several cancer-associated proteoglycans. VAR2 Pharmaceuticals has since 2015 shown in several peer-reviewed publications that oncofetal chondroitin sulfate is expressed in 95% of cancers with little to no expression detected in healthy tissues beyond the placenta. Read more about oncofetal chondroitin sulfate in our seminal publication: Salanti et al. 2015.
About Vartumabs
Vartumabs are a novel class of antibodies that bind specifically to oncofetal chondroitin sulfate. VAR2 Pharmaceuticals has shown that Vartumabs are efficacious and safe as cancer therapies in a range of preclinical models and as different therapeutic modalities, including antibody-drug conjugates, bispecifics, and T-cell therapies. Read more about Vartumabs in our seminal publication: Vidal-Calvo et al. 2024.