Advanced Cervical Cancer Vaccine Clinical Study Announced

Nykode Therapeutics ASA today announced a collaboration with the GOG Foundation, Inc. to conduct a clinical trial of VB10.16 in combination with an immune checkpoint inhibitor for treating advanced cervical cancer in the U.S.

VB10.16 is a potentially first-in-class off-the-shelf therapeutic cancer vaccine candidate in development for treating human papillomavirus type 16 (HPV16)-positive cancers.

The VB-C-04 trial will evaluate the combination therapies in patients with cervical cancer that have progressed following first-line treatment.

Nykode previously reported positive interim data from the Phase 2 VB-C-02 trial in Europe with women with heavily pre-treated advanced cervical cancer.

“Based on the positive interim data and in line with our potential registrational trial strategy, we look forward to starting the VB-C-04 trial in the U.S. The trial aims to provide a fast path to making VB10.16 available to patients,” stated Klaus Edvardsen, Chief Development Officer of Nykode Therapeutics, in a press release on February 10, 2023.

The cancer vaccine is designed based on Nykode’s Vaccibody™ technology platform of targeting antigens to antigen presenting cells.

VB10.16 has reported positive interim data from a Phase 2 trial in heavily pre-treated cervical cancer patients (NCT04405349).

The analysis demonstrated a favorable safety profile, with responses observed in both PD-L1 positive and negative patients (ORR 27% and 17%, respectively).

The vaccine-induced significant HPV16-specific T cell responses were associated with clinical responses.

The candidate has also demonstrated favorable clinical data in a Phase 1/2a study in pre-cancerous HPV16-induced high-grade cervical intraepithelial neoplasia (HSIL; CIN 2/3), demonstrating a statistically significant correlation of immune responses and clinical responses.

Since 1970, the GOG Foundation has conducted more than 350 clinical trials in the U.S. with 400 participating sites and 115,000 patients. The results of the GOG Foundation’s clinical trials have influenced the standard of care for numerous malignant gynecologic neoplasms.

Additional HPV vaccine news is posted at PrecisionVaccinations.com/HPV.