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DNA VACCINE

(against SARS-CoV-2 coronavirus)
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Introduction

Cell & Gene Therapy (CGT) Ltd is part of an international group of companies developing an innovative DNA-based vaccine against the SARS-CoV-2 coronavirus. Our proprietary DNA vectors encode the most immunogenic epitopes of key SARS-CoV-2 proteins, enabling a safe and effective approach to viral immunization

Achieved Milestones

Vaccine Construction

  • Developed a DNA vaccine composed of gene therapy vectors based on GDTT1.8NAS12, each encoding immunogenic epitopes of SARS-CoV-2 (S, M, and N proteins).

  • Established a method for large-scale production that ensures efficient cellular uptake due to the small size (under 2,600 bp) of each vector.

Safety and Efficacy

  • Excluded antibiotic resistance genes and viral genomic elements from every DNA vector, aligning with global regulatory recommendations.

  • Generated initial in vitro and in vivo data confirming the vaccine’s safety and immunogenic potential.

Producer Strains

  • Created Escherichia coli JM110-NAS strains capable of producing the gene therapy vectors without antibiotic selection.

  • Built a dedicated strain bank for scalable manufacturing

Patent Protection

  • A patent (No. 2712838) was issued on January 31, 2020, covering the GDTT1.8NAS12 base vector (priority date: September 4, 2018).

  • Launched an international patent process for the SARS-CoV-2 DNA vaccine (priority date: April 20, 2020).

Manufacturing Readiness

  • Prepared industrial process flow documentation, ensuring cost-effective production and acceptable pricing parameters.

Next Steps:

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  • Preclinical Studies

Preparing to launch preclinical trials in rats to assess the vaccine’s specific pharmacological activity, as well as acute and chronic toxicity evaluations.

  • Clinical Trials

Planning a comprehensive series of human clinical trials to confirm the vaccine’s efficacy and safety profile.

  • Regulatory Registration

Following successful trial completion, we will assemble and submit the required documentation for market authorization in key regions.

Project Goals

Our primary objective is to design, validate, and bring to market DNA vaccines that:

  1. Ensures Robust Expression
    Maximizes the expression of viral antigen genes by using multiple small gene therapy vectors rather than a single large construct.

  2. Meets Regulatory Safety Requirements
    Avoids antibiotic resistance genes and viral genome elements in line with guidance from global health agencies (FDA, EMA).

  3. Supports Industrial-Scale Production
    Utilizes a vector design (GDTT1.8NAS12) and proprietary producer strains enabling large-scale manufacturing at competitive cost levels.

  4. Establishes Versatile Strains and Processes
    Develops and maintains industrial strains carrying the DNA therapy vectors to facilitate ongoing vaccine production.

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By focusing on efficacy, safety, and scalability, CGT Ltd aims to deliver next-generation DNA vaccines that addresses crucial global health needs and adheres to the highest regulatory standards.

For more information, see our presentation: download here

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