Policy & Regulation
Nykode Therapeutics expands clinical collaboration with Roche for advanced cervical cancer trial
1 June 2023 -

Nykode Therapeutics ASA (OSE:NYKD), a clinical-stage biopharmaceutical company, announced on Thursday an expanded clinical collaboration and supply agreement with Swiss healthcare company Roche (SIX:ROG) to evaluate its cancer vaccine candidate, VB10.16, in combination with Roche's cancer immunotherapy atezolizumab (Tecentriq) in patients with advanced cervical cancer.

The VB-C-04 trial, expected to start in the fourth quarter of 2023 in the US, provides a potential fast-to-market path. Under the agreement Nykode will sponsor and fund the trial, while Roche will supply atezolizumab. Nykode retains global commercial rights to VB10.16.

Positive results from the Phase 2 VB-C-02 trial in Europe demonstrated an overall response rate (ORR) of 29%, median overall survival (mOS) greater than 25 months, and 6.3 months median progression-free survival (mPFS) in PD-L1+ patients. In the patient population relevant to the upcoming VB-C-04 trial, ORR was 40%, disease control rate was 80%, and mPFS was 16.9 months.

VB10.16, based on Nykode's Vaccibody technology platform, is a potentially first-in-class off-the-shelf therapeutic cancer vaccine candidate designed to target antigens to antigen-presenting cells.