A new partnership could make the UW-Madison a trial location to test a COVID-19 vaccine targeting those most vulnerable to the virus — including the elderly and people with weak immune systems.
The plan was announced Monday morning by the UW-Madison’s Waisman Biomanufacturing and Heat Biologics. The group’s mission is to advance new vaccines and therapeutics for early human clinical trials.
It would be part of phases 1 and 2 of clinical trials, beginning in early 2021, if chosen. The two groups have partnered before on two cancer vaccines, one of which is in a phase 2 trial, the other of which just completed a phase 2 trial.
The groups will make a COVID-19 vaccine an expedited priority. Carl Ross, managing director of Waisman Biomanufacturing says the group is “very excited to be able to offer what we have to this cause.”
His group has nearly two decades of experience working with private companies to develop vaccines, including work on such infectious diseases as HIV, Ebola, influenza, dengue fever and malaria. Heat Biologics has also worked on some of these, and other, vaccines.
Jeff Wolf, CEO of Heat believes the result of the work could be either a standalone COVID-19 vaccine, or something that “holds enormous promise in combination with other vaccines under development and in clinical trials by boosting the patient’s T-cell immunity.”
Heat’s vaccine will use a genetically engineered combination that includes a protein commonly found in human cells — called gp96 — as well as viral proteins, to stimulate a response from the body that could recognize and fight off the the pathogen with a “more robust response,” according to an in-house story from Waisman Biomanufacturing and Heat Biologics.
The UW-Madison’s biopharmaceutical contract manufacturer will provide Heat with comprehensive development and engineering services, as well as producing clinical batches of vaccines.
“Waisman Biomanufacturing is also able to provide broader flexibility than larger contract manufacturers that have more rigid policies and are less flexible to the needs of smaller companies,” says Brian Dattilo, Waisman Biomaufacturing’s manager of business development.
The UW-Madison’s story explains how the trial phases work: “Producing the COVID-19 vaccine for phase 1 and phase 2 trials is just one step in a series of milestones leading to the establishment of a vaccine for general use. Phase 1 trials are designed to demonstrate that a vaccine is safe for use. Once it passes that phase, trials move onto phase 2, which is where researchers test the effectiveness of the vaccine and continue to monitor safety. Phase 3 trials are designed to show that the vaccine works in a larger sampling of patients.”
