PDS Biotechnology Corp (NASDAQ:PDSB) said the consortium received a commitment from MCTI (The Ministry of Science, Technology, and Innovation of Brazil) to fund $60 million to develop the vaccine.
According to the communiqué from PDS, the COVID-19 consortium will utilize the funds to develop and commercialize the vaccine based on versamune to treat coronavirus in Brazil. The funding is subject to receipt of approval of Anvisa (Agência Nacional de Vigilância Sanitária), the regulatory authority of Brazil.
PDS will conduct Phase 1/ 2 clinical trial of the coronavirus vaccine in Q2 or Q3 2021. The company will use the funds for scaling up production and phase 3 clinical studies.
The consortium will collaborate to develop the vaccine efficiently, adhering to the regulatory guidelines. Scaling up of production will be undertaken in Q3 2021. MCTO agreed to provide funding after verifying the results of preclinical trials of the coronavirus vaccine
The coronavirus vaccine will combine Versamune® T-cell APT (activating platform technology) of PDS with a SARS-CoV-2 recombinant protein sourced from spike protein.
The vaccine showed strong potential to induce CD8+ in the preclinical trial to kill the virus and generate an immune response. PDS will engage 360 patients in Phase 1/ 2 clinical studies to assess the efficacy and safety of the COVID-19 vaccine. It will also study the T-cell responses during the trial in Brazil to control coronavirus.
Farmacore and PDS advances vaccine
The CEO of PDS, Frank Bedu-Addo, said the company and Farmacore Biotechnology advanced vaccine development to the clinical stage. According to the preclinical trials, the vaccine has the potential to promote anti-SARS-CoV-2 immune responses.
PDS intends to develop an effective COVID-19 vaccine to kill the mutant coronavirus as well. He praised the efforts of Blanver Farmoquímica and Farmacore Biotechnology in achieving this breakthrough. The company plans to conduct clinical trials quickly and commercialize the vaccine for human use.
The CEO of Farmacore, Helena Faccioli, said the company is pleased to advance the coronavirus vaccine’s development by joining hands with PDS teams. The company is excited to receive continued support from the Brazilian Government in its development efforts and finalize the protocols with Anvisa to conduct clinical studies.