Clinical stage biopharmaceutical company Heat Biologics, Inc. recently unveiled a new cellular vaccine platform that it says is designed to allow quicker manufacturing, greater stockpiling and customizability suited to combating a wide range of biological threats.
The emergence of the Omicron coronavirus variant highlights the need for a flexible vaccine platform that can provide a rapid, safe, and effective response to biological threats. And Heat Biologics said its new RapidVax vaccine platform has the potential to provide long-term biodefense capability to protect the United States in the event of a biological attack or accidental release of an infectious disease pathogen.
In an interview with Homeland Preparedness News, Jeff Wolf, founder and CEO of Heat Biologics based in Morrisville, N.C., labeled the RapidVax vaccine platform a “plug and play” model.
“RapidVax really presents a new paradigm in responding to biothreats,” Wolf said. “It’s different from anything else out there. It represents a different way we could respond to threats quickly with a different sort of vaccine, with a vaccine that’s really focused on T-cell generation, memory response, usable by itself or in combination with other vaccines…”
RapidVax leverages another proprietary vaccine platform developed by Heat called gp96, which primes living cells to activate immune responses against cancer and infectious diseases. RapidVax also provides a potent T-cell costimulatory molecule that helps generate long-lasting T-cell memory and B-cell neutralizing antibody production.
“With RapidVax, what we do is we mass produce cells,” Wolf said. “We mass produce unprogrammed cells. We store those cells. They sit in storage waiting to be programmed with the disease of interest. So then if a pathogen hits, like a new variant on COVID, we take the sequence – the plasmid – insert it into the cell, and voilà, we have a drug right there. We’ve dosed hundreds of patients with the same approach.”
The RapidVax platform could potentially allow quicker manufacturing of drugs, and in the process, carve months or years off the traditional development timetable. Full clinical trials would be needed for anything developed through this method, but with all of the base materials ready to go, the time to get into the clinic could be dramatically reduced. With only a mass of small cells to store, RapidVax materials could also be stockpiled to meet needs in the present or future.
Right now, Wolf said, the company is working on producing and characterizing those cells. Heat has three facilities across the country, including a manufacturing facility under construction in San Antonio, Texas, currently slated for completion in the first quarter of 2022. From discovery, to development, to clinical testing and manufacturing, Heat Biologics largely handles everything in-house.
Heat also formed a five-person Biothreat Advisory Board, with experts such as David Lasseter, former U.S. Deputy Assistant Secretary of Defense for Countering Weapons of Mass Destruction, and former U.S. Rep. Jack Kingston (R-GA). The board exists to help the company navigate the government’s needs and lend its expertise to helping Heat focus on versatile, timely responses to real world threats through its platforms.
“Neutralizing the threat of biological weapons or emerging infectious diseases has been elusive due to the number of potential agents and the timeline required to develop viable vaccines,” Lasseter said in a written statement. “The current COVID-19 pandemic has underscored societal risks and vulnerabilities to battle biological threats, whether by an intentional attack, accidental release, or naturally occurring infectious disease. RapidVax aims to provide a proven, safe, vaccine strategy that can be quickly engineered and adapted to address emerging biological threats.”
RapidVax was unveiled at the 2021 World Antiviral Congress that was held Nov. 30-Dec. 2. Its forebear, gp96, has led to multiple product candidates though, including one for non-small cell lung cancer that made it to Phase 2 clinical trial. Cellular vaccines based on the platform have demonstrated protection in mice and primate models against diseases such as malaria, HIV/SIV, Zika and SARs-CoV-2 in various U.S. Department of Defense and National Institutes of Health-funded studies.
“The goal of RapidVax is to be prepared in any eventuality, no matter the case. You give us the sequence, we can program it in. You give us plasma, we can rapidly respond to any biological threat,” Wolf said.