Cbio Receives European Clearance for First-in-Human Trial of Novel T-Cell Therapy in Cervical Cancer
Key Insights
Cbio A/S (search) has received European regulatory clearance to begin a Phase I/IIa clinical trial of novoleucel, a next-generation T-cell therapy targeting persistent or recurrent cervical cancer (search).
The first-in-class therapy addresses oxidative stress in the tumor microenvironment by armoring T-cells to resist reactive oxygen species and preserve their cancer-killing activity.
The study will enroll up to 20 patients at Karolinska University Hospital (search) in Stockholm, with initial safety and translational data expected by the end of 2026.
Cbio A/S (search) has received European regulatory clearance to begin a first-in-human Phase I/IIa clinical trial of novoleucel, the company's next-generation T-cell therapy designed to improve immune cell function in cancer patients. The study will enroll up to 20 patients with persistent or recurrent cervical cancer (search) at Karolinska University Hospital (search) in Stockholm, with the first patients expected to be treated within the coming months.
The milestone marks Cbio's transition into clinical development and represents a key value inflection point for the company as it advances its strategy to improve the effectiveness of cell-based therapies in solid tumors. Initial safety and translational data are expected by the end of 2026.
Addressing Critical Unmet Medical Need
"The regulatory clearance marks a defining milestone for Cbio," said Ulrik Cordes, Founder and CEO of Cbio. "Patients with recurrent cervical cancer (search) 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 (search) remains a major global health challenge, with more than 660,000 new cases diagnosed and 349,000 dying annually worldwide. The new cell-based therapy addresses a high unmet medical need for more effective treatment options.
Novel Mechanism Targets Oxidative Stress
Novoleucel is a first-in-class therapy designed to address the central challenge in cancer immunotherapy: oxidative stress within the tumor microenvironment that disables immune cells and limits therapeutic efficacy. The T-cells are armored to cope with this stress, increasing resistance to reactive oxygen species and helping preserve their cancer-killing activity inside tumors.
The therapy is based on discoveries from Professor Rolf Kiessling and Stina Wickström's research group at Karolinska Institute (search), pioneers in adoptive cell therapy.
"For many years we have studied how oxidative stress suppresses immune cells in tumors," said Rolf Kiessling. "By protecting tumor-reactive T-cells through activation of the Nrf-2 pathway (search), we aim to improve their persistence and anti-tumor activity. It is very gratifying to see this concept now entering clinical testing."
Clinical Trial Design and Manufacturing
The Phase I/IIa study will evaluate novoleucel in patients with persistent or recurrent cervical cancer (search) who have progressed after platinum-based chemotherapy and checkpoint inhibitors. The trial will assess safety, feasibility of manufacturing and delivery, persistence of infused T-cells, and early signals of clinical activity.
The therapy will be manufactured at Cbio's in-house GMP-certified cell therapy production facility in Copenhagen, Denmark, a 1,000 m² production facility dedicated to clinical-grade cell therapy manufacturing.
Financial Support and Future Development
Cbio is supported by a syndicate of Nordic and international investors and is raising additional capital to support the expansion of the Phase I/IIa clinical program and to further develop its broader cell therapy platform.
"Seeing the program now enter clinical testing is both a proud moment and an important step forward for patients," said Cecilia Hultén, Co-Founder and CFO in Cbio. "The start of the clinical program represents an important value inflection point for the company," said Christian Leroy, board member and investor in Cbio. "We believe Cbio is advancing a compelling approach to improving cell therapies for solid tumors and look forward to following the development of novoleucel."
The ongoing financing will support expansion of the clinical program and the generation of initial safety and translational data expected by the end of 2026.