Photo | Courtesy | UMass Medical School
Dr. Shan Lu
February 17, 2021
UMass Medical School-licensed HIV firm wins FDA approval
By Grant Welker
A biotechnology company working on a vaccine to prevent HIV, whose work is licensed by UMass Medical School in Worcester, has won U.S. Food and Drug Administration approval to advance its clinical work.
The firm, Worcester HIV Vaccine, was approved for the FDA's investigational new drug process for a vaccine that's aimed at preventing the virus that causes AIDS. An early-stage clinical trial is expected to start this month, with a second-phase trial to follow, the medical school said Friday.
The potential vaccine is based on discoveries by Dr. Shan Lu, a professor of medicine at UMass Medical School and licensed by the Worcester school. Worcester HIV Vaccine was founded more than two years ago, and the investigational drug approval by the FDA is a major achievement in its development, Yegor Veronin, the firm's COO, said in a statement.
Dr. Lu's lab at UMass has received more than $50 million in National Institute of Allergy and Infectious Diseases funding in the past 20 years to oversee the development and manufacturing of the vaccine, according to UMass.
“In order to stem the global tide of AIDS, finding an effective preventive HIV vaccine is our best hope of breaking the transmission cycle,” Dr. Lu said in a statement. “This brings promising new research into an HIV vaccine one step closer.”
Worcester HIV Vaccine is working with two partners on developing the vaccine: Wisconsin-based Waisman Biomanufacturing, a contract manufacturer helping to create the DNA substances used in the vaccine, and the Infectious Disease Research Institute in Seattle, which developed and manufactured the substance increasing the body's response to the vaccine.
The United States had 36,400 new HIV infections in 2018, according to the latest U.S. Department of Health & Human Services data. An estimated 1.2 million people nationwide have the virus, but one in seven don't know it. Worldwide, roughly 38 million had HIV in 2019, according to Department of Health & Human Services estimates.
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