COVID-eVax / Takis, Rottapharm Biotech - LARVOL DELTA

Development of novel genetic vaccine platforms: from the idea to GMP production. (ESGCT 2024) - "To address the urgent need to find solutions to the SARS-CoV-2 Pandemic, Takis has developed COVID-eVax, a vaccine approach based on genetic engineering and DNA electroporation as part of the X-eVax platform, previously developed...Recently, the first DNA vaccine against SARS-CoV-2 (ZyCov-D) has been registered in India for human use; moreover, DNA vaccines have been extensively tested in multiple clinical trials in the oncology field and are commonly used in veterinary medicine...This novel form of nucleic-acid vaccine has already proven to be efficacious in preventing SARS-CoV-2 infection in feline and ferret animal model. In this presentation, opportunities and challenges of DNA-based vaccines and Takis biotech experience will be discussed."

Infectious Disease • Respiratory Diseases

Immunogenicity of COVID-eVax Delivered by Electroporation Is Moderately Impacted by Temperature and Molecular Isoforms. (PubMed, Vaccines (Basel)) - "Surprisingly, the immune response induced in vivo was only minimally affected by the percentage of open circular DNA. This result suggests that plasmid DNA vaccines, such as COVID-eVax that have recently completed a phase I clinical trial, retain their efficacy upon storage at higher temperatures, and this feature may facilitate their use in low-/middle-income countries."

Journal • Gene Therapies • Infectious Disease • Novel Coronavirus Disease • Respiratory Diseases

A linear DNA vaccine candidate encoding the SARS-CoV-2 Receptor Binding Domain elicits potent immune response and neutralizing antibodies in domestic cats. (PubMed, Mol Ther Methods Clin Dev) - "Here, we show results from a clinical trial conducted in domestic cats to assess safety and immunogenicity of a linear DNA ("linDNA") vaccine encoding the Receptor Binding Domain (RBD) from SARS-CoV-2 (Lin-Covid-eVax)...Also, the linDNA vaccine induced neutralizing antibody titers against ancestral SARS-CoV-2 virus and its variants. These findings demonstrate the safety and immunogenicity of a genetic vaccine against COVID-19 administered to cats and strongly support the development of vaccines for preventing viral spread in susceptible species, especially those in close contact with humans."

Journal • Infectious Disease • Novel Coronavirus Disease • Respiratory Diseases

A first-in-human trial on the safety and immunogenicity of COVID-eVax, a cellular response-skewed DNA vaccine against COVID-19. (PubMed, Mol Ther) - "However, the vaccine did not induce neutralizing antibodies, while particularly relevant was the T cell-mediated immunity, with a robust Th1 response. This T cell-skewed immunological response adds significant information to the DNA vaccine platform and should be assessed in further studies for its protective capacity and potential usefulness also in other therapeutic areas, such as oncology."

Journal • P1 data • Fatigue • Immunology • Infectious Disease • Novel Coronavirus Disease • Oncology • Pain • Respiratory Diseases

Safety and Immunogenicity of COVID-eVax, a Candidate Plasmid DNA Vaccine for COVID-19, in Healthy Adult Volunteers (clinicaltrials.gov) - P1/2 | N=68 | Terminated | Sponsor: Takis | N=160 ➔ 68 | Trial completion date: Sep 2022 ➔ Dec 2021 | Active, not recruiting ➔ Terminated; The good progress of the Italian national vaccination campaign against COVID-19 made impossible to complete the study as planned.

Enrollment change • Trial completion date • Trial termination • Infectious Disease • Novel Coronavirus Disease • IFNG

DNA-Vaccine-Induced Immune Response Correlates with Lower Viral SARS-CoV-2 Titers in a Ferret Model. (PubMed, Vaccines (Basel)) - "Here, we describe the correlation between immune responses and the evolution of viral infection in ferrets infected with the live virus. We demonstrate COVID-eVax immunogenicity as means of antibody response and, above all, a significant T-cell response, thus proving the critical role of T-cell immunity, in addition to the neutralizing antibody activity, in controlling viral spread."

Journal • Preclinical • Infectious Disease • Novel Coronavirus Disease • Respiratory Diseases

Safety and Immunogenicity of COVID-eVax, a Candidate Plasmid DNA Vaccine for COVID-19, in Healthy Adult Volunteers (clinicaltrials.gov) - P1/2; N=160; Active, not recruiting; Sponsor: Takis; Recruiting ➔ Active, not recruiting

Clinical • Enrollment closed • Infectious Disease • Novel Coronavirus Disease • IFNG

Safety and Immunogenicity of COVID-eVax, a Candidate Plasmid DNA Vaccine for COVID-19, in Healthy Adult Volunteers (clinicaltrials.gov) - P1/2; N=160; Recruiting; Sponsor: Takis; Trial completion date: Jun 2022 ➔ Sep 2022; Trial primary completion date: Sep 2021 ➔ Dec 2021

Clinical • Trial completion date • Trial primary completion date • Infectious Disease • Novel Coronavirus Disease • IFNG

COVID-eVax, an electroporated plasmid DNA vaccine candidate encoding the SARS-CoV-2 Receptor Binding Domain, elicits protective immune responses in animal models of COVID-19. (PubMed, Mol Ther) - "In summary, this study identifies COVID-eVax as an ideal COVID-19 vaccine candidate suitable for clinical development. Accordingly, a combined phase I-II trial has recently started."

Journal • Preclinical • Infectious Disease • Novel Coronavirus Disease • Respiratory Diseases

Toxicity and Local Tolerance of COVID- eVax, a Plasmid DNA Vaccine for SARS-CoV-2, Delivered by Electroporation. (PubMed, Toxicol Pathol) - "Histopathological evaluation revealed muscle fiber necrosis associated with subchronic inflammation at the injection sites (at the 30-day time point), with a clear trend for recovery at the 57-day time point, which is expected following EP, and considered a desirable effect to mount the immune response against the target antigen. In conclusion, the intramuscular EP-assisted DNA vaccine, COVID-eVax showed an excellent safety profile in SD rats under these experimental conditions and supports its further development for use in humans."

Journal • Immunology • Infectious Disease • Inflammation • Novel Coronavirus Disease • Respiratory Diseases

[VIRTUAL] Takis srl (BIO 2021) - "POC of the technology successfully achieved for Cancer Vaccines in Veterinary applications and Phase 1 trials in humans.Takis has a diverse pipeline of projects based on DNA ElectroGeneTransfer ranging from Cancer, Malaria, and monoclonal antibodies. COVID-eVax is a vaccine against COVID-19 currently in PhaseI/II clinical trial planned to go on the market on 1Q22."

IO biomarker • Gene Therapies • Infectious Disease • Malaria • Novel Coronavirus Disease • Oncology

Safety and Immunogenicity of COVID-eVax, a Candidate Plasmid DNA Vaccine for COVID-19, in Healthy Adult Volunteers (clinicaltrials.gov) - P1/2; N=160; Recruiting; Sponsor: Takis

Clinical • New P1/2 trial • Infectious Disease • Novel Coronavirus Disease • IFNG

Study to determine the safety and immunogenicity of COVID-eVax, a vaccine for COVID-19 in healthy adult volunteers. Studio per determinare la sicurezza e l’immunogenicità di COVID-eVax, un vaccino per COVID-19 in volontari sani adulti. (clinicaltrialsregister.eu) - P1/2; N=160; Ongoing; Sponsor: Takis S.r.l.

Clinical • New P1/2 trial • Infectious Disease • Novel Coronavirus Disease

Italian DNA-based COVID-19 vaccine candidate could start clinical trials in March - developer (Reuters) - "Italy’s second COVID-19 vaccine candidate, COVID-eVax, is likely to start trials in early March after it was approved by the national drug regulator last week...'We expect to start the first week of March, complete phase 1 in July and phase 2 in October,' Lucio Rovati, chairman and scientific director of Rottapharm told Reuters. 'Then we expect to have finished Phase 3 in spring 2022,' he said."

New P1 trial • New P2 trial • New P3 trial • Infectious Disease • Novel Coronavirus Disease

Applied DNA Sciences up 121% on advancement of coronavirus vaccine (SeekingAlpha) - “Nano cap Applied DNA Sciences (APDN +121.1%) is the latest tiny company to enjoy a COVID-19-related pop. In this case, in response to its announcement that Italy's Ministry of Health has signed off on a preclinical trial of a COVID-19 vaccine candidate (one of four) that the company is jointly developing with collaboration partner Takis Biotech.”

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