The trial is focusing on subjects with resectable melanoma or squamous cell carcinoma of the head and neck. Credit: Pormezz / Shutterstock.

Danish biotechnology company IO Biotech has finished enrolling subjects in a Phase II trial of its lead therapeutic cancer vaccine candidate, IO102-IO103, in conjunction with MSD’s KEYTRUDA (pembrolizumab).

The multicentre IOB-032/PN-E40 basket trial has enrolled 93 subjects with resectable melanoma or squamous cell carcinoma of the head and neck (SCCHN) across Europe, Australia and the US.

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Its aim is to assess the safety, biomarker data and anti-tumour activity of the combination therapy.

The study’s primary endpoint is the major pathologic response (MPR) in subjects, focusing on viable tumour cell reduction following neoadjuvant treatment.

Its secondary endpoints are safety, pathological complete response, disease-free survival, overall response rate and event-free survival.

IO Biotech CEO and president Mai-Britt Zocca said: “We are pleased to have completed enrolment early in this study, as it signifies an important step in exploring the potential of our investigational therapeutic cancer vaccine, IO102-IO103, across a range of solid tumours at an earlier stage of disease progression.

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“With data from our Phase III trial in patients with advanced melanoma expected in the first half of 2025 and initial data from this Phase II basket trial also expected in 2025, we hope to add to the accumulating evidence of potential benefit of this combination therapy across a range of difficult-to-treat cancers.”

IO102-IO103 is an immune-modulatory off-the-shelf vaccine designed to eliminate tumour cells and immune-suppressive cells within the tumour microenvironment by activating T cells against cells expressing indoleamine 2,3-dioxygenase (IDO1) and/or programmed death-ligand 1 (PD-L1).

IO Biotech is sponsoring the clinical trial, while US-based pharmaceutical company MSD is providing the anti-PD-1 therapy, pembrolizumab.

Based in Copenhagen, IO Biotech develops novel, immune-modulatory therapeutic cancer vaccines based on its proprietary T-win platform.

In November 2023, the company finished enrolling subjects in its Phase III IOB-013/KN-D18 trial investigating the IO102-IO103 combination therapy for the treatment of advanced melanoma.