DTMT Network

Norwegian pharmaceutical company Nykode Therapeutics has announced recently that the interim results of its Phase 2 VB C-02 trial of its new VB10.16 therapeutic cancer vaccine, in combination with atezolizumab in patients with HPV16-positive advanced cervical cancer that the combination therapy showed a very high disease control rate of 64% among the heavily pre-treated patient population.

In a statement released on May 09, 2022, the company informed that the interim results from 39 patients with a median follow up of 6 months show an overall response rate (ORR) of 21%.

The combination treatment showed anti-tumour activity among both PD-L1 positive with 27% ORR and 77% disease control rate (DCR) as well as PD-L1 negative patients (ORR of 17% and DCR of 58%) indicating a potential clinical benefit also in the PD-L1 negative population, the statement added.

Additionally, patients with non-inflamed tumours, including both immune desert and T cell excluded tumours exhibited a DCR of 71%, the company further informed.

Nycode said that together these findings suggest a differentiated anti-tumour 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-tumour activity in a heavily pre-treated population of patients with late-stage cervical cancer,” Nykode’s CEO, Michael Engsig said.

 “These interim results support Nykode’s unique approach of targeting Antigen-Presenting Cells (APCs), designed to produce a robust and long-lasting CD8 killer T cell response against cancer cells,” he added.

Immunological analyses of the peripheral T cell responses demonstrated an increased HPV16- specific interferon 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, Nykode said.

“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,” Professor Peter Hillemanns, Director of the Departments of Gynecology, Obstetrics and Breast Cancer at Hannover University Hospital, Germany and principal investigator of the trial said.

“It is very encouraging to see that a majority of patients experienced a clinical benefit and that many patients had durable responses,” he added.

Pointing out that treatment advances for advanced cervical cancer have been limited though checkpoint inhibitors have demonstrated clinical efficacy in some patients, Chief Medical Officer of Nykode  Dr Siri Torhaug said, “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-tumour activity seen in both non-inflamed 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,” she added.

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 favourable safety profile that is consistent with previously published data for the Nykode DNA vaccine technology platform, the company informed.

Nykode said that it expects to report updated efficacy data read-outs from VB C-02 during the first half of 2023.