PDS Biotechnology Corp (PDSB)

[Desert dweller]

I don't understand why PDSB hasn't released a PR on the submission by Farmacore.

Farmacore PR regarding submission for approval

Brazilian company Farmacore Biotechnology announces that it has submitted the pre-clinical data package of the versamune ®-CoV-2FC vaccine for analysis by Anvisa

Thursday, 18 February 2021 10:25

Called Versamune®-CoV-2FC, the vaccine is the combination of a recombinant protein from SARS-CoV-2 itself, co-developed by Farmacore and PDS Biotech

The Brazilian company Farmacore Biotechnology, in partnership with the U.S. company PDS Biotechnology Corporation, has just submitted the regulatory data package Vaccine Versamune®-CoV-2FC against COVID-19 for analysis by ANVISA, in order to obtain agreement for the project and strategy for human testing phase 1/2. The company presented promising and robust preclinical data in tests already performed on rodents with the S1 protein associated with the Versamune vaccine platform®.

Called Versamune®-CoV-2FC, the vaccine is the combination of a recombinant protein from SARS-CoV-2 itself, co-developed by Farmacore and PDS Biotech, with the nanotechnology of the Versamune® platform by PDS Biotech, a patented technology for the activation of immune system T cells and antibody production. The vaccine is funded by the Ministry of Science, Technology and Innovations (MCTI) and is within the strategies stipulated by redevirus MCTI.

The results obtained so far demonstrate that the vaccine induces the generation of neutralizing antibodies and, at the same time, reinforces the immune response by activating the cell defense system. The expectation is that this combination – the generation of antibodies against S protein and T-cell activation – will provoke a robust immune response and offer long-term immunization, capable of tackling virus mutations.

Versamune® is a highly innovative and unique vaccine platform in its ability to promote the induction of strong CD8+ T-cell responses against viral targets. In the versamunevaccine formulation®-CoV-2FC, the use of s1 protein (which includes RBD) that contains conserved T-cell epitopes of the virus allows the induction of CD8+ and CD4+ T-cell responses directed against non-variable (conserved) regions of the virus. This approach offers potential for long-term protection against multiple virus mutations.

The project has received investment from the Ministry of Science, Technology and Innovation to perform part of the pre-clinical studies and is seeking funding for the execution of clinical trials.

Pharmacore is in contact with specific government agencies with the aim of extending pre-clinical funding to cover the next human clinical trial, scheduled to begin in the first half of 2021.

"Preclinical results demonstrated 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 moving forward with our studies, which shows the potential for new Versamune-based vaccines®, to provide long-term protection against SARS-Cov2 (COVID 19) virus infection."

"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 greater clinical potential and that we can progress more quickly," said Helena Faccioli, CEO of Farmacore. "We are excited to continue advancing in the partnership with PDS Biotech and to have the support of ANVISA to provide the opportunity to develop a treatment in Brazil in the fight against this pandemic." – complements the executive.

The companies plan to use several research and development sites in the United States and Brazil to advance the 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-stage immunotherapy company with an increasing number of cancer immunotherapies and infectious disease vaccines based on the Versamune-t-cell activation technology platform ® (company intellectual property). Versamune® effectively provides disease-specific antigens for in vivo uptake and processing, in addition to activating the important immunological pathway of type 1 interferon, resulting in the production of potent "killer" T cells, 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, focusing on research and development of innovative immunobiological products for use in the human health and veterinary 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 at all stages of development, from project design to the production of biomolecules www.farmacore.com.br.

About Versamune®-CoV-2FC

Versamune®-CoV-2FC is a vaccine project for COVID-19 that combines the Versamune® immune activation platform with a recombinant fusion protein developed by Farmacore from Coronavirus 2, 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 infection.

About RedeVirus MCTI

Committee created by MCTI in February 2020 that brings together experts, government representatives, ministry funding agencies, research centers and universities with the aim of integrating and implementing initiatives to combat emerging viruses, including the development of national vaccines to cope with COVID-19.


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