MADISON – Waisman Biomanufacturing at the University of Wisconsin-Madison is partnering with Heat Biologics to produce a COVID-19 vaccine for phase 1 and phase 2 clinical trials. Phase 1 trials could begin in early 2021 and UW-Madison may be a trial site.
The vaccine will target those most vulnerable to COVID-19 – namely, 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,” says Jeff Wolf, CEO of Heat.
Heat’s vaccine will use a genetically engineered combination of a common protein already found in human cells called gp96, along with viral proteins, to stimulate a response from the body’s T-cells, a type of immune cell.
The vaccine enables long-term cellular immunity by teaching the T-cells to recognize and fight off the pathogen in the future and stave off infection. 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.
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,” says 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 comprehensive development and engineering services. Waisman Boimanufacturing will also produce clinical batches of vaccines using current good manufacturing practices, or GMP by industry lingo.
“We operate collaboratively for novel phase 1 products while maintaining a high level of GMP compliance,” Dattilo says. “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.”
Established in 2001, Waisman Biomanufacturing has a nearly two-decade history of working with researchers and private companies to develop and produce vaccines. The facility’s portfolio includes production of plasmid DNA and recombinant proteins and it also specializes in the sterile filling of liquid products – a process that uses a robotic system to finalize production.
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.
Vaccines traditionally work by promoting the immune system’s production of antibodies, which then target the pathogen.
Heat’s technique has been adapted and tested in collaboration with researchers at the University of Miami in a number of studies funded by the National Institutes of Health and the Department of Defense, including as a vaccine in animal models of Zika virus, malaria, and SIV/HIV.
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.
Ross says that any project related to COVID-19 will be expedited and given high priority.
“Waisman Biomanufacturing staff are continually motivated by the impact that we have in bringing novel biologics to the clinic. COVID-19 takes that impact to the next level, as it has had far-reaching effects on our people and our society.”
Waisman Biomanufacturing previously partnered with Heat on two cancer vaccines, one of which is in a phase 2 clinical trial; the other completed enrollment in a phase 2 trial.
“Our previous experience in the production of gp96 vaccines with Heat will enable greater speed to the clinic, which is extremely important,” says 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.”
“Waisman is a great partner that has proven themselves to be very fast and efficient at manufacturing our cell-based therapeutics. They understand our process and unique needs well. We look forward to working with them yet again on this very important project,” says Wolf.