Copenhagen-based biotech company FluoGuide A/S has announced the submission of a Clinical Trial Application (CTA) for a phase 2 trial in head and neck cancer, specifically oral squamous cell carcinoma.

This marks a significant step forward for the company, which specialises in precision cancer surgery. The trial will evaluate the efficacy of FG001, a product designed to enhance surgical accuracy by illuminating cancer cells.

The CTA submission follows promising results from a proof-of-concept phase 2 clinical trial. Feedback from key opinion leaders globally has confirmed the significant needs of patients with head and neck cancers.

This has led to a detailed understanding of the clinical trial design and how to optimise FG001’s positioning from a regulatory, partnering and commercial perspective.

The phase 2 trial, designated CT-005, will be a single-centre study aiming to evaluate multiple endpoints with FG001 in patients undergoing surgery for head and neck cancer.

The trial will enrol 25-30 patients, with the first patient expected to be enrolled in Q1 2025 and the last in H2 2026. Interim data are anticipated in H2 2025.
Discussions with regulatory and clinical experts, including Principal Investigator Prof Max Witjes, have been instrumental in shaping the trial design. The study aims to provide valuable insights into the clinical applications of FG001.

Transgene, a biotech company specialising in virus-based immunotherapies for cancer, has announced that its phase 2 trial of TG4001 in combination with avelumab did not meet its primary objective of improving progression-free survival in patients with recurrent or metastatic HPV16-positive cervical and anogenital cancers.

Despite this setback, a pre-planned subgroup analysis revealed a positive efficacy trend in favour of the TG4001 regimen among cervical cancer patients.

This subgroup, which makes up about half of the study’s participants, showed promising results that warrant further investigation, particularly in relation to PD-L1 status.

Dr Alessandro Riva, Chairman and CEO of Transgene, commented: “Failure to meet the primary objective in our phase 2 study with TG4001 is disappointing.  Nevertheless, we are encouraged by the positive efficacy trend in favour of the combination regimen in cervical cancer patients.”

He added: “We plan to complete a full and rigorous analysis of the data before deciding on any path forward for this asset, in particular in cervical cancer, in the context of the evolving treatment landscape.”

The treatment was well tolerated, with adverse events consistent with previous observations. Transgene is currently conducting a detailed evaluation of the full study results and will provide further updates once this analysis is complete.

Dr Riva added: “The complete study results will be presented at an upcoming scientific conference. We would like to thank all the patients and caregivers who have taken part in this study for their important contribution.”

Transgene remains focused on advancing its lead asset, TG4050, an individualised cancer vaccine for head and neck cancers, with additional data expected in November 2024.