The name change is to signify a new phase of growth and development. “Nykode translates as ‘new code’, playing on the potential of our technology to generate novel codes and create innovative patient therapies,” said the Oslo headquartered player.
The agreement with Regeneron includes five distinct programs, three within cancer and two within infectious diseases. For confidentiality reasons, the companies are not disclosing disease targets at this juncutre, according to a spokesperson.
Each of the five programs may include several vaccine candidates, said the parties, and all of which would be eligible for milestone and royalty payments. The candidates will combine Regeneron’s antigen selection expertise and VelociSuite in vivo models with Nykodes’ modular vaccine platform and vaccine design expertise.
Nykode will work on vaccine generation and characterization, as well as product supply through the end of Phase 1 trials. Regeneron will be responsible for antigen identification, preclinical and clinical development, manufacturing, from the end of Phase 1 trials, and commercialization.
Under the terms of the deal, the Norwegian company will receive an upfront payment of US$30m and an equity investment of US$20m at a premium of 20% of its share price. It will also be eligible to receive more than US$875m in additional payments based on future development and commercial achievements, plus royalties.
Nykode also has collaborations with Roche, Genentech and Nektar Therapeutics within oncology, and it is teaming up with Adaptive Biotechnologies for COVID-19 T cell vaccine development.
Its lead product candidates are:
- VB10.16, a therapeutic vaccine for the treatment of human papilloma virus 16 induced malignancies which is in Phase 2 for the treatment of cervical cancer.
- VB10.NEO, a cancer neoantigen vaccine, which is exclusively out licensed to Genentech and is in Phase 1b for the treatment of locally advanced and metastatic tumors and Phase 1/2a for the treatment of melanoma, lung-, head and neck, renal, and bladder cancer.
Michael Engsig, company CEO, told BioPharma-Reporter in October 2020 that VB10.NEO targets encoded antigens to antigen presenting cells, which are essential for generating potent T cell responses required for cancer therapy. It has demonstrated the ability to induce an immune response against the majority of the neoantigens targeted by the vaccine, he said.
“Preliminary results from the Phase I/IIa clinical trial suggest a link between selection of high quality neoepitopes, generation of broad neoepitope-specific CD8+ T cell responses and potential clinical benefit.”
He also outlined then how the team was very enthusiastic about the capabilities of the company’s platform in relation to infectious diseases. “We have generated a lot of promising preclinical data, both with viral and bacterial antigens, and we believe there is a huge potential for single dose efficacy and/or low doses due to the unique targeting to antigen presenting cells.”
This year saw the Norwegian firm initiate a Phase 1/2 trial in 2021 with its two next-generation COVID-19 vaccine candidates.