GRONINGEN, NETHERLANDS (25 September 2024) – VAR2 Pharmaceuticals ApS (“VAR2 Pharma”), a Danish biotechnology company, has officially received regulatory approval for its first-in-human Phase 0 clinical trial. This trial, named VARTUTRACE, will assess the tolerability, and biodistribution, and safety of two zirconium-89-labeled single-chain variable fragments (scFvs) through PET/CT molecular imaging. The study will be conducted in the Netherlands, with patient recruitment set for Q4 2024.
First in-human study after successful preclinical results
Preclinical studies have demonstrated that VAR2 Pharma’s antibodies (“Vartumabs”) selectively target tumors, and they will now be tested in patients with various solid cancers for the first time. This study aims to investigate the safety, tolerability, and biodistribution of two Vartumabs across multiple cancer types.
Clinical trial design
Designed by TRACER CRO, the trial will include 16 patients per compound. Each participant will receive a microdose, which is not intended to be therapeutic but sufficient for PET imaging. A key secondary goal of this study is to identify which tumor types show the highest uptake, which will help guide future clinical studies. Demonstrating tumor-specific binding in humans is anticipated to clear the way for developing oncology diagnostics and therapeutics based on Vartumabs.
Oncofetal chondroitin sulfate
Oncofetal chondroitin sulfate is a long, heavily sulfated sugar chain found in several cancer-associated proteoglycans. Since 2015, VAR2 Pharmaceuticals has published peer-reviewed studies demonstrating that oncofetal chondroitin sulfate is expressed in 95% of cancers, with little to no expression in healthy tissues, except in the placenta. For more information, refer to our foundational publication: Salanti et al. 2015.
Vartumabs
Vartumabs represent a new class of antibodies that specifically target oncofetal chondroitin sulfate. VAR2 Pharmaceuticals has shown in preclinical models that Vartumabs are both safe and effective as cancer therapies. They have been tested in various therapeutic forms, including antibody-drug conjugates, bispecifics, and T-cell therapies. Learn more in key publication: Vidal-Calvo et al. 2024.
VAR2 Pharmaceuticals ApS
VAR2 Pharmaceuticals is a clinical-stage biotech company focused on developing first-in-class antibodies targeting oncofetal chondroitin sulfate, a tumor-specific glycosaminoglycan expressed in various cancers. Discovered during malaria research, this carbohydrate modification offers a promising target for cancer treatment. Founded in 2012 and based in Copenhagen, VAR2 Pharmaceuticals has raised over €25M to date. The company’s team is dedicated to developing effective cancer therapies, particularly for hard-to-treat, recurrent, and metastatic cancers. For more information, visit www.var2pharma.com.
A great fit with TRACER CRO
TRACER CRO specializes in optical and nuclear molecular imaging within clinical trials. By labeling compounds for imaging, critical biodistribution and pharmacokinetic data can be obtained. This approach, suitable for Phase 0 exploratory trials, allows for data collection with microdosing studies, often preceding Phase I trials. TRACER works with drug developers to quickly evaluate their compounds in patients.
