On May 9, 2022 Nykode Therapeutics AS (Euronext Growth (Oslo): NYKD), a clinicalstage biopharmaceutical company dedicated to the discovery and development of vaccines and novel immunotherapies, reported positive interim results from its Phase 2 VB C-02 trial of VB10.16, its wholly-owned therapeutic cancer vaccine, in combination with the PD-L1 inhibitor atezolizumab in patients with HPV16-positive advanced cervical cancer (Press release, Nykode Therapeutics, MAY 9, 2022, View Source [SID1234613862]). Interim results from 39 patients with a median follow up of 6 months show an ORR of 21%—including two patients who achieved a complete response and six who achieved a partial response—and a very high disease control rate of 64%. The trial enrolled a heavily pre-treated patient population with more than two thirds of the patients having received at least two previous systemic lines of treatment.
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Interestingly, anti-tumor activity was observed in both PD-L1 positive (ORR of 27% and DCR of 77%) and PD-L1 negative patients (ORR of 17% and DCR of 58%) indicating a potential clinical benefit also in the PD-L1 negative population. In addition, a DCR of 71% was observed in patients with noninflamed tumors, including both immune desert and T cell excluded tumors. Together these findings suggest a differentiated anti-tumor response pattern of the combination treatment compared to checkpoint inhibitor monotherapy.
"We are thrilled to report these positive interim safety and efficacy results from our Phase 2 trial with VB10.16, which showed evidence of durable anti-tumor activity in a heavily pre-treated population of patients with late-stage cervical cancer," said Michael Engsig, Chief Executive Officer of Nykode Therapeutics. "These interim results support Nykode’s unique approach of targeting AntigenPresenting Cells (APCs), designed to produce a robust and long-lasting CD8 killer T cell response against cancer cells. We look forward to reporting updated efficacy data readouts from the Phase 2 trial during the first half of 2023 as we continue to advance our cervical cancer program."
Immunological analyses of the peripheral T cell responses demonstrated an increased HPV16-specific IFN T cell immune response post-vaccination in the majority of subjects and were associated with clinical efficacy indicating the induction of clinically relevant T cell responses. Clearance of circulating HPV16 DNA was significantly correlated with clinical response and progression free survival suggesting ctDNA may be an early marker of response to treatment in cervical cancer. VB10.16 is potentially a first-in-class therapeutic vaccine against HPV16-positive cervical cancer.
"The patients who were treated with VB10.16 in combination with atezolizumab in the C-02 trial were heavily pre-treated and are prone to progress quickly," said Professor Peter Hillemanns, Director of the Departments of Gynecology, Obstetrics and Breast Cancer at Hannover University Hospital, Germany and principal investigator of the C-02 trial. "It is very encouraging to see that a majority of patients experienced a clinical benefit and that many patients had durable responses. The combination of VB10.16 and atezolizumab was also well tolerated by patients."
"Treatment advances within the area of advanced cervical cancer have been limited though checkpoint inhibitors have demonstrated clinical efficacy in some patients. The unmet need is still high, and we are very pleased to see a high disease control rate and durable responses in these heavily pre-treated HPV16+ cervical cancer patients. The anti-tumor activity seen in both noninflamed and PD-L1 negative populations may potentially open up a new subset of patients for treatment. These findings indicate that VB10.16 may give a meaningful added clinical benefit compared to the existing standard of care treatment in this setting. We would like to thank all the investigators, patients and their relatives for participating in this trial. Without all of you the advances of VB10.16 would not have been possible," added Siri Torhaug, Chief Medical Officer of Nykode Therapeutics.
VB10.16 was generally safe and well tolerated, with 10% of patients experiencing Grade 3 or more treatment-related adverse events, indicating no increased toxicity compared with atezolizumab monotherapy and a favorable safety profile that is consistent with previously published data for the Nykode DNA vaccine technology platform. Nykode expects to report updated efficacy data read-outs from VB C-02 during the first half of 2023. Webcast Investors and analysts are invited to join a webcast presentation of the interim results conducted by CEO Michael . The slide presentation will be available in the Investors section of the Company’s website at View Source following the event. The live and archived webcast of the presentation can be accessed in the Investors section of the Company’s website at View Source/financial-reports-and-presentations.
About the VB C-02 trial VB C-02 is a multi-center, single arm, open-label Phase 2 trial of patients with advanced or recurrent, non-resectable HPV16-positive cervical cancer. Patients received treatment with VB10.16 in combination with the PD-L1 inhibitor atezolizumab for up to one year. The main aim of the trial was to assess the efficacy, immunogenicity and safety of VB10.16 when given in combination with atezolizumab. The trial is now fully enrolled with 52 patients enrolled at sites in Europe, and the preplanned second interim analysis was performed at the cut-off date of 14 February 2022. Nykode has previously reported positive interim safety data from the trial. Additional information about the VB C-02 trial is available at clinicaltrials.gov (NCT04405349).
About VB10.16
VB10.16 is a potentially first-in-class off-the-shelf therapeutic cancer vaccine candidate in development for the treatment of human papillomavirus type 16 (HPV16)-positive cancers. The cancer vaccine is designed based on Nykode’s Vaccibody technology platform of targeting antigens to antigen presenting cells. The candidate has demonstrated favorable clinical data in a Phase I/IIa 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. VB10.16 is currently being investigated in the VB C-02 trial in patients with advanced or recurrent, non-resectable HPV16-positive cervical cancer.
About cervical cancer
Cervical cancer is the fourth leading cause of cancer death in women worldwide and is most frequently diagnosed between the ages of 35 and 44. Each year around 600,000 women are diagnosed with cervical cancer worldwide. Almost all cases are caused by human papillomavirus (HPV) infection and HPV16 accounts for more than half of all cervical cancer cases. Approximately 80% of patients with cervical cancer have squamous cell carcinoma (arising from cells lining the bottom of the cervix) and most other patients have adenocarcinomas (arising from glandular cells in the upper cervix). Cervical cancer is often curable when detected early and effectively managed, but treatment options are more limited in advanced disease stages or when the cancer has spread.