Our history

A remarkable story of giant steps forward and focused endeavor

Nykode Therapeutics ASA (Oslo Stock Exchange (OSE): NYKD) is a listed, clinical-stage biopharmaceutical company, dedicated to the discovery and development of vaccines and novel immunotherapies. The company is based on the technology conceived and developed at the University of Oslo and Oslo University Hospital in the laboratory of Professor Bjarne Bogen, with contributions from Professor Inger Sandlie.

 

Nykode Therapeutics has developed a unique and innovative modular technology platform, targeting antigen to Antigen Presenting Cells, with the aim to treat and prevent cancer as well as autoimmune diseases. Through its innovative design, Nykode’s proprietary vaccine platform generates fast, strong, long-lasting and broad antibody and T cell responses, leading to remarkably potent vaccines and immunotherapies.

Timeline

2006

November 2006

Company founded under the name Vaccibody AS.

2014

December 2014

Platform patent granted by European Patent Office.

2015

September 2015

Vaccination of first patient in Phase I/IIa study with VB10.16 immunotherapy for patients with HPV16 induced high-grade lesions of the cervix.

January 2015

Platform patent granted by U.S. Patent Office.

2016

December 2016

Successful Private Placement of NOK 220 million.

August 2016

Positive results from Phase I of VB C-01 trial in patients with high-grade cervical dysplasia; continued to the expansion Phase (IIa).

2017

June 2017

Positive results from Phase I of VB C-01 trial, a first human dose, open-label, multicenter Phase I/IIa study of VB10.16 immunotherapy for the treatment of high-grade Cervical Intraepithelial Neoplasia.

March 2017

Vaccination of first patient in Phase IIa study with VB10.16 immunotherapy for patients with HPV16 induced high-grade lesions of the cervix.

2018

September 2018

  • New clinical collaboration with Nektar Therapeutics to evaluate Nykode’s personalized cancer neoantigen vaccine, VB10.NEO, in combination with Nektar’s CD-122-biased agonist, NKTR-214.
  • Positive 6-month interim results from Phase IIa of VB-C-01 trial.

April 2018

Initiated enrollment of the cancer neoantigen Phase I/IIa clinical trial.

2019

November 2019

Initial data showed positive clinical responses in patients with locally advanced or metastatic cancer treated with VB10.NEO.

June 2019

Reported strong neoantigen-specific T cell responses induced in the first four cancer patients with low mutational burden after VB10.NEO vaccination.

April 2019

Nykode and Nektar Therapeutics present new preclinical data for VB10.NEO combined with bempegaldesleukin (NKTR-214) at the American Association for Cancer Research (AACR) Annual Meeting 2019.

March 2019

Positive 12-month results from VB-C-01 Phase IIa trial in high-grade cervical dysplasia, providing proof of concept for Nykode’s platform technology and drug candidate VB10.16.

February 2019

Collaboration with Roche to explore a combination of Nykode’s VB10.16 and immune-checkpoint inhibitor atezolizumab (Tecentriq®) in advanced cervical cancer.

2020

October 2020

Entered into a worldwide license and collaboration agreement with Genentech, a member of the Roche Group, to develop an individualized neoantigen cancer vaccine.

August 2020

  • Reached enrollment target of 50 patients and finalized recruitment of patients to all study arms of the VB N-01 Phase I/IIa trial of the personalized VB10.NEO neoantigen cancer vaccine.
  • First patient dosed in the combination therapy of the Phase 1/2a study evaluating bempegaldesleukin, Nektar’s CD122-preferential IL-2 pathway agonist, with VB10.NEO, Nykode’s personalized neoantigen cancer vaccine, in patients with advanced head and neck squamous cell carcinoma (HNSCC).

July 2020

First patient dosed in the VB C-02 Phase II trial with VB10.16 in combination with atezolizumab.

2021

November 2021

Entered into multi-target license and collaboration agreement with Regeneron to develop novel and innovative vaccines against cancer and infectious diseases.

July 2021

Entered into a worldwide license agreement with Adaptive Biotechnologies for clinically validated SARS-CoV-2 T cell epitopes.

June 2021

Initiated a Phase 1/2 trial to evaluate two second-generation SARS-CoV-2 virus vaccine candidates.

2022

December 2022

  • Entered into clinical collaboration with MSD to evaluate VB10.16 in combination with KEYTRUDA® (pembrolizumab) in patients with HPV16-Positive Head and Neck cancer.
  • Entered into strategic manufacturing partnership with Richter-Helm BioLogics.
  • Expanded clinical development plans for VB10.16 in HPV16-positive cancers.

October 2022

Positive immunogenicity results from the VB-N-01 Phase 1/2a study of VB10.NEO.

September 2022

Positive results from the Phase 1/2 open label, dose escalation trial of T Cell focused SARS-CoV-2 vaccine candidate.

June 2022

Nykode uplisted to the main list of the Oslo Stock Exchange.

May 2022

Positive interim results from the VB-C-02 Phase 2 trial with VB10.16 in combination with immune checkpoint inhibitor atezolizumab in advanced cervical cancer.

2023

December 2023

Expansion of oncology pipeline with preclinical program aimed at reducing the burden of colorectal cancer.

October 2023

Successful Private Placement of NOK 505 million (USD 45 million) in gross proceeds.

September 2023

  • FDA approval of IND for VB-C-04 trial of VB10.16 in HPV16-positive cervical cancer.
  • Initiated Phase 1/2a VB-C-03 trial of VB10.16 in first line HPV16-positive Head & Neck cancer.

June 2023

Expansion of clinical collaboration with Roche to evaluate VB10.16 in combination with anti-PD-L1 in the VB-C-04 trial in advanced cervical cancer.

April 2023

Positive results from Phase 2 VB-C-02 trial of VB10.16 in combination with PD-L1 inhibitor atezolizumab in advanced cervical cancer.

February 2023

Entered into collaboration with The GOG Foundation, Inc. to conduct the VB-C-04 trial in advanced cervical cancer.

2024

August 2024

Issuance of key patent covering VB10.NEO in the US.

May 2024

Expansion of clinical collaboration with MSD to evaluate VB10.16 in combination with KEYTRUDA® (pembrolizumab) in patients with HPV16-positive high-risk locally advanced cervical cancer.

March 2024

  • Announced topline conclusions affirming prolonged clinical benefits from matured survival data in the VB-C-02 Phase 2 C-02 trial in advanced cervical cancer.
  • Announced advances in the inverse vaccine platform with the potential to treat autoimmune diseases.