Vaccibody Has a New Name and a Fresh Partnership with Regeneron

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Norwegian company Vaccibody has changed its name to Nykode Therapeutics. A company announcement said “Nykode” means “new code,” which is “playing on the potential of our technology to generate novel codes and create innovative patient therapies.”

The company focuses on neoantigen cancer vaccines. Neoantigens are new proteins that form on cancer cells as the result of mutations in tumor DNA. Neoantigen vaccines are designed to identify tumor-specific neoantigens and activate the immune system to recognize and attack the cancer cells. They also have programs for vaccines against infectious diseases, including COVID-19.

“Over the last few years, the company has made significant steps forward,” said Michael Engsig, chief executive officer of Nykode. “We have reported promising clinical data, continued to grow our pipeline and forged significant partnerships. We continue our exciting transformation from a two-asset focused company to a fully-fledged platform biotech company. During the past year, we have increased the number of talented colleagues, made important additions to our senior management team, invested strategically, and expanded internationally. This positive evolution, combined with our future ambitions, inspired the need to revisit our brand.”

The company also inked a license and collaboration deal with U.S.-based Regeneron Pharmaceuticals for five programs for off-the-shelf vaccines for cancer and infectious disease. Regeneron is paying Nykode $30 million upfront and $20 million in company shares at a premium of 20% of Nykode’s share price. Nykode has an upside potential of $875 million in various milestone payments, as well as royalties on any products that make it to market that come out of the partnership. Regeneron is covering all research, development and commercialization expenses.

Nykode has five programs, three for cancer and two for infectious diseases, which would be eligible for milestone and royalty payments. Potentially, each program might include several vaccine candidates.

The collaboration will leverage Regeneron’s antigen selection expertise and its VelociSuite in vivo models and Nykode’s modular vaccine platform and vaccine design expertise. Nykode will handle vaccine creation,  characterization, and product supply to the end of Phase I clinical studies. Regeneron will handle antigen identification, preclinical and clinical development, manufacturing from the end of Phase I, and commercialization activities.

“Collaborating with Nykode Therapeutics will bring another dimension to Regeneron’s already robust research and development programs for oncology and infectious disease and, in particular, provides new opportunities to help people with challenging tumor types or infectious diseases with high unmet need,” said Gavin Thurston, Ph.D., senior vice president, Oncology Research, at Regeneron. “Nykode Therapeutics’ platform efficiently delivers vaccine payloads to antigen presenting cells and allows for vaccine candidates that can be easily manufactured. It has already shown robust CD8+ antigen-specific T cell responses in animal models and in patients with cancer. Combining their platform with our industry-leading VelociSuite technologies and expertise may help to accelerate this emerging and promising therapeutic approach.”

On November 3, Nykode announced it had launched its VB-D-01 Phase I/II trial and dosed the first patient in its trial of a COVID-19 vaccine, VB10-2129. It also has another COVID-19 vaccine arm, VB10-2210. It is a two-arm, open-label, dose-escalation and dose-expansion study.

VB10-2129 is a second-generation receptor-binding domain (RBD) vaccine candidate. It was designed using the Beta variant and made to generate RBD-specific antibody and T cell immunity. The third-generation T cell epitope vaccine candidate, VB10-2210 codes immunodominant T cell epitopes that have been identified and validated by Adaptive Biotechnology. These epitopes cross multiple antigens on SARS-CoV-2.

In addition to its collaboration with Regeneron and Adaptive Biotechnology, Nykode has partnerships with Roche, Genentech, and Nektar Therapeutics within oncology. Lead products include VB10.16, for human papilloma virus 16–induced cancers and VB10.NEO, a cancer neoantigen vaccine with Genentech for locally advanced and metastatic tumors and for melanoma, lung, head and neck, renal, and bladder cancer.

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