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Biotech / Medical : 2021 Biotech Stock Picking Charity Contest
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From: nigel bates3/11/2021 9:35:51 AM
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PDSB up 25% this morning.

FLORHAM PARK, N.J., March 11, 2021 (GLOBE NEWSWIRE) -- PDS Biotechnology Corporation (Nasdaq: PDSB), a clinical-stage immunotherapy company developing novel cancer therapies and infectious disease vaccines based on PDS Biotech’s proprietary Versamune® T-cell activating technology, today announced that its COVID-19 vaccine consortium consisting of PDS Biotech, Farmacore Biotechnology and Blanver Farmoquímica, has received a commitment from the Secretary for Research and Scientific Training of the MCTI to fund up to approximately US$60 million to support the clinical development and commercialization of a novel, Versamune®-based, second generation COVID-19 vaccine in Brazil.

MCTI intends to start making the funds available to prepare to perform a combined Phase 1/2 clinical trial, upon authorization by the Brazilian regulatory agency, Agência Nacional de Vigilância Sanitária (Anvisa) to initiate the proposed Versamune®-based COVID-19 vaccine clinical program in Brazil.

The pre-IMPD package for the Phase 1/2 trial is currently under review by Anvisa and the trial is anticipated to begin by Q2/3 2021. The majority of the capital provided by MCTI will fund the manufacturing process scale up, production and the Phase 3 trial, pending the results of the Phase 1/2 trial. The consortium members will work under a mutually agreed work plan to guide the vaccine efficiently through development in compliance with regulatory standards. The consortium anticipates working to initiate manufacturing scale up activities in the second quarter.
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