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 infectious 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
November 2006
Company founded under the name Vaccibody AS.
December 2014
Nykode Granted Platform Patent by European Patent Office.
January 2015
Platform Patent granted by U.S. Patent Office.
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.
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).
December 2016
Successful Private Placement of NOK 220 million.
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.
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.
April 2018
Nykode announces informed consent signed by the first patient and enrollment process initiated in the cancer neoantigen Phase I/IIa clinical trial.
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.
February 2019
- Collaboration with Roche to explore a combination of Nykode’s VB10.16 and immune-checkpoint inhibitor atezolizumab (Tecentriq®) in advanced cervical cancer.
- Private placement of NOK 230 million.
March 2019
Positive 12-month results from VB-C-01 Phase IIa trial in high-grade cervical dysplasia, providing proof of concept for its platform technology and drug candidate VB10.16.
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.
June 2019
Reported strong neoantigen-specific T cell responses induced in the first four cancer patients with low mutational burden after VB10.NEO vaccination.
November 2019
Initial data showed positive clinical responses in patients with locally advanced or metastatic cancer treated with VB10.NEO.
July 2020
First patient dosed in the VB-C-02 Phase II trial with VB10.16 in combination with atezolizumab.
August 2020
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).
August 2020
Reached enrollment target of 50 patients and has 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.
October 2020
Entered into a worldwide license and collaboration agreement with Genentech, a member of the Roche Group, to develop individualized neoantigen cancer vaccine.
June 2021
Initiates a Phase 1/2 trial to evaluate two second-generation SARS-CoV-2 virus vaccine candidates.
July 2021
Entered into a worldwide license agreement with Adaptive Biotechnologies for clinically validated SARS-CoV-2 T cell epitopes.
November 2021
Entered into multi-target license and collaboration agreement with Regeneron to develop novel and innovative vaccines against cancer and infectious diseases.
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.
June 2022
Nykode uplisted to the main list of the Oslo Stock Exchange.
September 2022
Positive results from the VB-D-01 Phase 1/2 open label, dose escalation trial of T Cell focused SARS-CoV-2 vaccine candidate.
October 2022
Positive immunogenicity results from the VB-N-01 Phase 1/2a study of VB10.NEO.
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.
February 2023
Entered into collaboration with The GOG Foundation, Inc. to conduct 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.
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.
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
October 2023
Successful Private Placement of NOK 505 million (USD 45 million) in gross proceeds.
December 2023
Expansion of oncology pipeline with preclinical program aimed at reducing the burden of colorectal 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.
April 2024
Initiated the VB-C-04 Phase 2 trial of VB10.16 in second line HPV16-positive cervical cancer.
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.
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