Nordic biotech innovator Cbio has cleared a major regulatory hurdle, receiving approval to start a first-in-human Phase I/IIa trial of novoleucel, its next-generation T-cell therapy aimed at boosting immune cell function in cancer patients.

 

The study will enroll up to 20 patients with persistent or recurrent cervical cancer at Karolinska University Hospital in Stockholm, with treatments expected to begin in the coming months. Early safety and translational results are anticipated by the end of 2026.

 

“The regulatory clearance marks a defining milestone for Cbio,” said Ulrik Cordes, Founder and CEO. “Patients with recurrent cervical cancer have very limited treatment options once standard therapies fail. We believe that novoleucel has the potential to significantly transform the treatment landscape and are excited to begin evaluating this novel approach in patients.”

 

Cervical cancer remains a major global health challenge, claiming 349,000 lives annually and affecting more than 660,000 people worldwide. 

 

Novoleucel is designed to meet this urgent need by overcoming a key obstacle in cancer immunotherapy: oxidative stress in the tumor microenvironment that weakens immune cells and limits treatment effectiveness. The therapy’s “armored” T-cells are engineered to resist this stress, preserving their cancer-fighting activity inside tumors.

 

The therapy stems from the pioneering work of Professor Rolf Kiessling and Stina Wickström at Karolinska Institute, experts in adoptive cell therapy.

 

“For many years we have studied how oxidative stress suppresses immune cells in tumors,” said Kiessling. “By protecting tumor-reactive T-cells through activation of the Nrf-2 pathway, we aim to improve their persistence and anti-tumor activity. It is very gratifying to see this concept now entering clinical testing.”

 

Cbio will produce novoleucel in its GMP-certified cell therapy facility in Copenhagen, a 1,000 m² operation dedicated to clinical-grade manufacturing.