The decision was taken after a successful meeting with the Agency, where promising and robust preclinical data was presented in tests already carried out on rodents with vaccine formulation

The vaccine that aims to prevent infection by Covid-19, developed by the Brazilian biotechnology company  Farmacore , in partnership with  PDS Biotechnology Corporation , has just received support from the National Health Surveillance Agency (ANVISA) to submit the documentation of non-clinical trials for initial analysis and subsequent submission of the protocol for the clinical trial. The decision was made after a successful meeting with the Agency, where promising and robust preclinical data was presented in tests already carried out on rodents with the vaccine.

Named  Versamune®-CoV-2FC,  the vaccine is the combination of a recombinant SARS-CoV-2 protein, developed by Farmacore, associated with the Versamune ® carrier  , from  PDS  Biotech , a patented technology for the activation of the immune system.

“ PDS Biotech and Farmacore are now one step closer to being able to move forward with studies and create a vaccine to combat COVID-19 through the nanotechnology of the Versamune® platform ,”  said  Dr. Frank Bedu-Addo , CEO of PDS Biotech.

“ Pre-clinical results have demonstrated the potential to induce a broad and robust immune response. We look forward to evaluating our vaccine in partnership with Farmacore in human clinical trials and to move forward with our studies, which show the potential of new Versamune®-based vaccines, to provide long-term protection against SARS-Cov2 virus infection (Covid 19). “

” In this global pandemic, it is the responsibility of the scientific community to be flexible and to ensure that we are prioritizing the vaccine with the greatest clinical potential and that we can progress more quickly, “ said Helena Faccioli, CEO of Farmacore. “ We are excited to continue to advance in the partnership with PDS Biotech and to have the support of ANVISA to continue the studies that allow the development of treatment in Brazil in the fight against this pandemic. “

The companies plan to use several research and development sites in the United States and Brazil to make progress in preclinical and clinical development of the vaccine. Farmacore will lead regulatory and clinical trial efforts in Brazil, while PDS Biotech will continue to contribute scientific knowledge and operational support.

About PDS Biotechnology

PDS Biotech is a clinical immunotherapy company with an increasing number of immunotherapies against cancer and vaccines against infectious diseases based on the Versamune® T-cell activation technology platform   (intellectual property of the company). The  Versamune®  effectively provides disease-specific antigens to capture and process in vivo, in addition to activating the important immune via the type 1 interferon, resulting in the production of the potent T-cells “killer” as well as neutralizing antibodies. PDS Biotech has created several therapies based on combinations of  Versamune® and disease-specific antigens, designed to train the immune system to better recognize disease cells and effectively attack and destroy them. To learn more, visit  www.pdsbiotech.com  or follow us on Twitter at @PDSBiotech.

About Farmacore

Farmacore is a biotechnology company founded in 2005 as a startup, with a focus on research and development of innovative immunobiological products for use in the human and veterinary health sectors. It is a technology-based company that conducts research and development of biotechnological products and processes for the human and veterinary sectors. It develops innovative biotechnological and immunobiological products and adds value to them in all stages of development, from the design of the project to the production of biomolecules  www.farmacore.com.br .

Farmacore is installed at the Supera Parque Business Center in Ribeirão Preto.

About Versamune®-CoV-2FC

The  Versamune®-CoV-2fc   is a vaccine project for COVID-19 that combines the platform  Versamune®  of immune activation with a recombinant fusion protein developed by  Farmacore  from 2 coronavirus, the Severe Acute Respiratory Syndrome (SARS-CoV- 2) recognizable by our immune system (antigen). The target profile of the vaccine is to provide rapid induction of neutralizing antibodies, as well as killer T-cells and memory T-cells against the SARS-CoV-2 virus, in patients vaccinated with Versamune®-CoV-2FC to protect against COVID-19 and prevent the spread of the infection.