Waisman Biomanufacturing at the University of Wisconsin (UW)–Madison partnered with Heat Biologics to produce a COVID-19 vaccine for Phase I and Phase II clinical trials. Phase I trials could begin in early 2021, and UW–Madison may be a trial site.

The vaccine will target those most vulnerable to COVID-19, i.e., the elderly and those with health conditions that weaken their immune system. This includes people with heart conditions, severe obesity, diabetes, chronic kidney disease, and liver disease.

“In addition to its potential as a standalone COVID-19 vaccine, we believe this platform holds enormous promise in combination with other vaccines under development and in clinical trials by boosting the patient’s T-cell immunity,” said Jeff Wolf, CEO of Heat.

Heat’s vaccine will use a genetically engineered combination of a common protein already found in human cells (gp96), along with viral proteins, to stimulate a response from the body’s T cells.

Because Heat’s vaccine is designed to be combined with traditional vaccines to provide an extra immune boost, it could help individuals with weakened immune systems mount a more robust response, pointed out Wolf, who noted that recent data suggest that the type of T-cell immune response generated by this approach is important for preventing COVID-19 infection.

“Waisman Biomanufacturing’s mission is to advance novel vaccines and therapeutics into early human clinical trials,” added Carl Ross, managing director of Waisman Biomanufacturing, part of the Waisman Center. “We are very excited to be able to offer what we have to this cause.”

According to Brian Dattilo, Waisman Biomanufacturing manager of business development, the UW–Madison biopharmaceutical contract manufacturer will provide Heat with development and engineering services. Waisman Biomanufacturing will also produce clinical batches of vaccines using current good manufacturing practices (GMP).

“We operate collaboratively for novel Phase I products while maintaining a high level of GMP compliance,” Dattilo said. “As a smaller contract manufacturer, Waisman Biomanufacturing is able to be flexible to the needs of smaller companies.”

Established in 2001, Waisman Biomanufacturing has worked with researchers and private companies to develop and produce vaccines. The facility’s portfolio includes the production of plasmid DNA and recombinant proteins, and it also specializes in the sterile filling of liquid products.

Waisman Biomanufacturing has worked on other vaccine projects for infectious diseases such as HIV, ebola, influenza, dengue fever, malaria, and hand, foot, and mouth disease.

Heat’s technique has been adapted and tested in collaboration with researchers at the University of Miami in several studies funded by the NIH and the Department of Defense, including a vaccine in animal models of Zika virus, malaria, and SIV/HIV.

Waisman Biomanufacturing previously partnered with Heat on two cancer vaccines, one of which is in a Phase II clinical trial; the other completed enrollment in a Phase II trial.

“Our previous experience in the production of gp96 vaccines with Heat will enable greater speed to the clinic, which is extremely important,” said Ross. “For the COVID-19 vaccine, we have an existing set of manufacturing batch records and analytical methods to enable rapid production of the COVID-19 vaccine.”

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