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BIOQUAL Announces Publication of an Investigational COVID-19 Vaccine Candidate That Prevents Severe Clinical Disease in Animals

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A major objective of a COVID-19 vaccine is to prevent severe disease onset in SARS-CoV-2 infected people. Beth Israel Deaconess Medical Center (BIDMC) immunologist Dan H. Barouch, MD, PhD, and colleagues, including members of the staff at BIOQUAL, showed in recently published previous work that a candidate COVID-19 vaccine raised neutralizing antibodies that robustly protected non-human primates (NHPs) against SARS-CoV-2, the virus that causes COVID-19. In new research published September 3 in Nature Medicine, Barouch and colleagues demonstrated that the optimal vaccine elicited robust immune response in Syrian golden hamsters and prevented severe clinical disease — including weight loss, pneumonia, and death.

The vaccine — developed through a collaboration between BIDMC and Janssen Pharmaceutical Companies of Johnson & Johnson (Janssen) — uses a common cold virus, called adenovirus serotype 26 (Ad26), to deliver the SARS-CoV-2 spike protein into host cells, where it stimulates the body to raise immune responses against the coronavirus.

In the current study, the researchers immunized Syrian golden hamsters with a single injection of the Ad26-based SARS-CoV-2 vaccine, which induced neutralizing antibodies in all animals. Four weeks later, the animals were exposed to a high dose of SARS-CoV-2. Vaccinated animals lost less weight and had less virus in their lungs and other organs than unvaccinated control animals. Vaccinated animals also demonstrated lower mortality. Moreover, the researchers found that neutralizing antibody responses were inversely correlated with weight loss and viral loads in respiratory tissues. Ad26.COV2.S is currently being evaluated in clinical studies to establish the performance of the vaccine candidate in humans.

In July 2020, investigators at Janssen, Beth Israel Deaconess Medical Center (BIDMC), and other institutions initiated a first-in-human Phase 1/2 clinical trial of the Ad26.COV2.S vaccine in healthy volunteers. Pending clinical trial out-comes, the Ad26.COV2.S vaccine is on track to start a phase 3 efficacy trial in up to 60,000 participants in September 2020.

Co-authors included Lisa H. Tostanoski, Katherine McMahan, Noe D. Mercado, Jingyou Yu, Cesar Piedra-Mora, Esther A. Bondzie, Gabriel Dagotto, Make S. Gebre, Catherine Jacob-Dolan, Fijian Lin, Shant H. Mahrokian, Felix Nampanya, and Ramya Nityanandam of BIDMC; Frank Wegman, Jerome Custers, Hanneke Schiutemaker, and Roland Zahn of Janssen Vaccines & Prevention BV; Amanda J. Martinot, Linda M. Wrijil, and Sarah Ducat of Cummings School of Veterinary Medicine at Tufts University; Carolin Loos, Caroline Atyeo, Stephanie Fischinger, John S. Burke, Jared Feldman, Blake M. Hauser, Timothy M. Caradonna, Galit Alter, and Aaron G. Schmidt of Ragon Institute of MGH, MIT, and Harvard; Chi N. Chan, Stephen Bondoc, Carly E. Starke, Michael Nekorchuck, Kathleen Busman-Sahay, Jacob D. Estes of Oregon Health & Sciences University; Laurent Pessaint, Maciel Por-to, Vanessa Ali, Dalia Benetiene, Komlan Tevi, Hanne Andersen, and Mark G. Lewis of Bioqual; and Douglas A. Lauffenburger of Massachusetts Institute of Technology.

This project was funded in part by the Bill & Melinda Gates Foundation (INV- 226 006131); Janssen Vaccines & Prevention BV; Ragon Institute of MGH, MIT, and Harvard; Mark and Lisa Schwartz Foundation; Massachusetts Consortium on Pathogen Readiness (MassCPR); the National Institutes of Health (OD024917, AI129797, AI124377, AI128751, AI126603 to D.H.B.; AI007387 to L.H.T.; AI146779 to A.G.S.; AI135098 to A.J.M.; and OD011092, OD025002 to J.D.E.); the Department of Health and Human Services Biomedical Advanced Research and Development Authority (BARDA) under contract HHS0100201700018C; a Fast Grant, Emergent Ventures, Mercatus Center at George Mason University to A.J.M.

Statements herein that are not descriptions of historical facts are forward-looking and subject to risks and uncertainties. Actual results could differ materially from those currently anticipated due to a number of factors including risks relating to the ability to continue to extend current government contracts; the Company's ability to obtain new government or commercial contracts; continued demand for the use of animal models in scientific research; the Company's ability to perform under its contracts in accordance with the requirements of the contracts; the actual costs incurred in performing the Company's contracts and its ability to manage its costs, including its capital expenditures; dependence on third parties; future capital needs; the ability to fund its capital needs through the use of its cash on hand and line of credit; and the future availability and cost of financing/capital sources to the Company.

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