Nykode Therapeutics ASA, a pioneering clinical-stage biopharmaceutical company dedicated to advancing novel immunotherapies and focused on the discovery and development of innovative treatments, Nykode Therapeutics aims to address critical medical needs, particularly in the field of cancer research, has started a significant Phase 2 clinical trial named VB-C-04, marking a promising development in cancer treatment. The trial focuses on VB10.16, a potential cancer vaccine for HPV16-positive cancers, used alone or combined with Roche’s atezolizumab marketed as Tecentriq.

This trial, led by the GOG Foundation, Inc. in the United States, aims to assess the efficacy and safety of VB10.16, particularly in patients with recurrent or metastatic cervical cancer resistant to standard treatments. Dr. Bradley Monk, Director of GOG, highlighted the collaboration's importance, expressing optimism about its potential to impact cancer care positively.

Klaus Edvardsen, Chief Development Officer of Nykode Therapeutics, emphasized the trial's significance in addressing a pressing medical need. He underscored VB10.16's favorable clinical profile and its potential as an innovative immunotherapy for HPV16-positive cancers.

VB10.16 functions as a DNA-based cancer vaccine, leveraging Nykode's Vaccibody™ technology platform to target antigens. Initial studies have shown promising results, with significant HPV16-specific T cell responses observed. Moreover, the vaccine has exhibited favorable outcomes in pre-cancerous conditions.

The trial, named VB-C-04, is a two-phase study designed to enroll patients with advanced cervical cancer. Step 1 will involve assessing VB10.16 alone or combined with atezolizumab as a second-line treatment. Step 2 will follow, with the potential addition of more patients based on Step 1's outcomes.

It is worthwhile to note that cervical cancer ranks as the fourth leading cause of cancer-related deaths among women globally, with HPV16 infection accounting for a significant proportion of cases. While early detection offers promising outcomes, treatment options for advanced stages remain limited.

The commencement of the VB-C-04 trial marks a pivotal advancement in the ongoing pursuit of enhanced therapies for HPV-positive cervical cancer. This crucial milestone heralds a new era in medical research, offering a glimmer of hope for individuals grappling with the complexities of this formidable disease. Building upon encouraging preliminary findings, this groundbreaking therapy holds the potential to transform the landscape of cervical cancer treatment, providing renewed optimism and tangible prospects for improved patient outcomes. As researchers and clinicians unite in their efforts to unlock the full potential of this innovative approach, the VB-C-04 trial stands as a beacon of progress, guiding us towards a future where effective solutions are within reach for those affected by HPV-positive cervical cancer.