Presentation

Nykode Therapeutics is a Norwegian clinical-stage biopharmaceutical company that develops vaccines and immunotherapies for cancer and infectious diseases. The lead candidates are VB10.16, a therapeutic vaccine for HPV-16 induced malignancies, which has demonstrated positive interim efficacy and safety from its Ph2 trial for cervical cancer; and VB10.NEO, an individualised cancer neoantigen vaccine exclusively out-licensed to Genentech (Roche) in ongoing clinical trials. Nykode has also initiated a Ph1/2 trial with two next-generation COVID-19 vaccine candidates.

Recent highlights
In December, Nykode announced first subject dosed with its next-generation SARS-CoV-2 vaccine candidate. In April, Nykode presented preclinical data of its second generation Vaccibody vaccine technology incorporating immune-stimulatory cytokines, showing an expansion of antigen-specific polyfunctional effector T cells, superior tumour control, and enhanced APC infiltration, proliferation and differentiation. In May, Nykode announced positive interim results from its Ph2 trial, showing that VB10.16 in combination with atezolizumab demonstrated an ORR of 21%, including 2 CRs and 6 PRs, in a heavily pre-treated population of HPV16-positive advanced cervical cancer; additionally, the antitumour activity was observed both in PD-L1 positive (ORR of 27%; DCR of 77%) and PD-L1 negative patients (ORR of 17%; DCR of 58%). In June, the company was uplisted to the main list of the Oslo Stock Exchange.

Outlook
The company aims to initiate the Ph1b trial of VB10.16 in combination with a check point inhibitor in HPV16-positive squamous cell head & neck cancer patients, and present Ph1 key results measuring T cell and antibody responses in previously vaccinated SARS-CoV-2 subjects, both in H2 2022.