Nykode Therapeutics Announces Positive Results from the Phase 1/2 Open Label, Dose Escalation Trial of its T Cell Focused SARS-CoV-2 Vaccine Candidate

• Nykode’s vaccine candidate boosted Spike-specific T cell responses and induced de novo T cell responses to non-Spike antigens found across SARS-CoV-2 variants
• Nykode’s Vaccibody technology combined with immunogenic T cell epitopes selected by Adaptive Biotechnologies generated broad and CD8 dominated T cell responses post-vaccination
• Nykode’s vaccine candidate was safe and well-tolerated at all three dose levels
  

OSLO, Norway, Sept. 27, 2022 (GLOBE NEWSWIRE) -- Nykode Therapeutics ASA (OSE: NYKD), a clinical-stage biopharmaceutical company dedicated to the discovery and development of novel immunotherapies, today announced positive clinical results from the Phase 1/2 open label, dose escalation trial of Nykode’s T cell focused pan-SARS-CoV-2 vaccine candidate (VB10.2210) in healthy individuals who were previously vaccinated with an approved mRNA vaccine. T cell responses were analyzed by ex vivo ELISpot up until day 35. VB10.2210 induced broad and strong T cell responses, dominated by killer CD8 T cells, against both Spike- and non-Spike antigens. It was safe and well-tolerated at all three dose levels.

Approved vaccines are based on Spike, a protein subject to high immune selection pressure and mutation frequency. By contrast, VB10.2210 is designed to induce T cell responses against epitopes from seven additional antigens that are highly conserved across previous and existing SARS-CoV-2 variants. Nykode’s candidate is therefore expected to retain efficacy independent of future Spike mutations and would not need to be updated for future variants of concern.

“The results successfully demonstrate proof of concept of Nykode’s Vaccibody™ platform’s ability to induce a powerful immune response by delivering selected antigens to Antigen Presenting Cells,” stated Klaus Edvardsen, Chief Development Officer of Nykode Therapeutics. “Importantly, our vaccine, which incorporates T cell epitopes selected by Adaptive Biotechnologies, induced killer CD8 T cell responses against non-Spike antigens conserved across all major variants of concern, in addition to generating a broad and strong T cell response to the Spike antigen in healthy individuals. Further, the trial supports the favorable safety profile of our Vaccibody technology as observed in previous trials.”

“I am very excited with these results, which also demonstrate the value of our strategic partnership with Adaptive and the synergistic potential of our technologies in the clinic,” said Michael Engsig, Chief Executive Officer of Nykode Therapeutics. “We will further assess the evolution of the pandemic and the overall regulatory environment in order to determine the next steps for VB10.2210. Beyond COVID, and based on the successful proof of concept results, we are now exploring additional opportunities to encode Adaptive discovered T cell epitopes in Nykode’s technology with the potential to treat other diseases with high unmet medical need.” 

The open label Phase 1/2 trial, VB-D-01 (NCT05069623), is a two-arm trial to evaluate the safety, reactogenicity and immunogenicity of VB10.2210 in healthy, previously vaccinated individuals. 34 participants were enrolled and received at least one dose of VB10.2210 and 24 participants across the three dose levels were evaluable for immunogenicity analysis.

The vaccine candidate VB10.2210 encodes both Spike- and non-Spike T cell epitopes, identified and validated by Adaptive Biotechnologies. The immune response was assessed using five different peptide pools including the relevant epitopes from each of the following antigens: Spike, Membrane Glycoprotein (M), Nucleocapsid Protein (N), Orf1ab+Orf3+Orf10 and Orf7.

Highlights

• The vaccine candidate VB10.2210 induced de novo T cell responses to all four non-Spike antigens conserved across SARS-CoV-2 variants
• The vaccine candidate boosted a strong Spike response
• The responses were dominated by killer CD8 T cells in all subjects  
• The vaccine candidate was safe and well-tolerated at all three dose levels

Additional information
Further information will be available in a slide presentation in the Investors section of the Company’s website at https://nykode.com/investors/financial-reports-and-presentations.

About VB10.2210
VB10.2210 is a T cell focused vaccine candidate, encoding 96 clinically validated T cell epitopes spanning a total of eight SARS-CoV-2 proteins, including Spike. These Spike- and non-Spike T cell epitopes have been identified and validated by Adaptive Biotechnologies using their immune medicine platform. VB10.2210 is designed to prime T cells, potentially generating a broad immune response against current and future variants.

About Nykode Therapeutics
Nykode Therapeutics is a clinical-stage biopharmaceutical company dedicated to the discovery and development of novel immunotherapies for the treatment of cancer and infectious diseases. Nykode’s modular vaccine technology specifically targets antigens to Antigen Presenting Cells, which are essential for inducing rapid, strong and long-lasting antigen specific immune responses and eliciting efficacious clinical responses.

Nykode’s lead product candidates are VB10.16, a therapeutic vaccine for the treatment of human papilloma virus (HPV)-16 induced malignancies which demonstrated positive interim efficacy and safety results from its Phase 2 trial for the treatment of cervical cancer; and VB10.NEO, an individualized cancer neoantigen vaccine, which is exclusively out-licensed to Genentech, a member of the Roche Group, 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. Additionally, Nykode is conducting a Phase 1/2 trial with two next-generation COVID-19 vaccine candidates.

The Company’s partnerships include Genentech within oncology, a multi-target collaboration with Regeneron within oncology and infectious diseases and a collaboration with Adaptive Biotechnologies for COVID-19 T cell vaccine development.

Nykode Therapeutics’ shares are traded on the Oslo Stock Exchange (OSE: NYKD). Further information about Nykode Therapeutics may be found at http://www.nykode.com.

Contact for Nykode Therapeutics ASA:
Chief Business Officer, Agnete Fredriksen
Nykode Therapeutics ASA
[email protected]

Nykode Therapeutics ASA
Oslo Science Park
Gaustadalléen 21
N-0349 Oslo, Norway

Forward-looking statements for Nykode Therapeutics
This announcement and any materials distributed in connection with this announcement may contain certain forward-looking statements. By their nature, forward-looking statements involve risk and uncertainty because they reflect the company's current expectations and assumptions as to future events and circumstances that may not prove accurate. A number of material factors could cause actual results and developments to differ materially from those expressed or implied by these forward-looking statements.