Nykode Therapeutics Announces Advances in Clinical Pipeline and Research - Seite 2

VB10.16 is Nykode’s wholly owned candidate for treatment of HPV16-driven cancer types. Nykode is presenting additional data from the VB-C-02 trial which strongly supports the generation of durable clinically relevant T cell responses. The evidence includes the formation of multiple and enduring T cell clones post-vaccination and significant changes in blood cell composition. A robust correlation observed between HPV16 circulating tumor DNA and clinical outcomes. This correlation is discernible from the first measured post-vaccination timepoint which supports further exploration of HPV16 circulating tumor DNA as an early predictor of clinical outcome.

Nykode has received FDA approval for its potentially registrational VB-C-04 trial, which is on track to initiate in the fourth quarter of the year. The trial builds on the positive data from the VB-C-02 trial indicating differentiated and durable anti-tumor responses. The VB-C-04 trial plans to enroll 130 patients with recurrent or metastatic cervical cancer, who have previously undergone first-line standard of care treatment (comprising pembrolizumab, chemotherapy, and optionally, bevacizumab). Part A of the trial will involve a randomized allocation of 30 patients each to receive either VB10.16 in combination with Atezolizumab or VB10.16 monotherapy. After an interim analysis, the superior treatment arm will be expanded to include an additional 70 patients.

Nykode is expanding into first-line treatment for PD-L1-positive patients with head and neck cancer and has secured all the necessary regulatory approvals to initiate the VB-C-03 trial.

“Taken together, the new data combined with previously presented clinical data reinforces Nykode’s confidence in the focused strategy to develop VB10.16 for advanced cancer types and furthermore points to a significant future commercial upside in earlier stages of cancer.” said Klaus Edvardsen, Chief Development Officer of Nykode Therapeutics.

VB10.NEO: pioneering neoantigen research

• Vaccine-specific T cells remain functional and immunogenic up to 1-year after last vaccination.
• Multiple vaccinations boost the breadth and magnitude of functional T cell responses.

In-depth analysis of data stemming from Nykode’s fully personalized neoantigen trial, VB-N-01, has yielded encouraging results. Enduring immune responses to the vaccine neoantigens have been observed, persisting for at least one year following the administration of the last dose of VB10.NEO. This evidence reaffirms the ability to generate long-lasting T cell responses. VB10.NEO is exclusively outlicensed to Genentech, a member of the Roche Group. The VB-N-01 trial was conducted by Nykode prior to the outlicensing of VB.10.NEO to Genentech.