The company’s saRNA vaccine technology, using its proprietary LION™ delivery system, already has proved successful in development of COVID-19 vaccines

 SEATTLE, WA (August 23, 2022) – HDT Bio Corp., a developer of immunotherapies for oncology and infectious diseases, announced today it has entered into a collaboration agreement with the National Cancer Institute (NCI), part of the U.S. National Institutes of Health, to develop cancer vaccines using self-amplifying RNA (saRNA) and the company’s proprietary LION™ delivery system.

“We are excited to partner with the NCI in applying our unique saRNA vaccine technology for co-development of vaccines to treat and prevent cancers such as those of the pancreas, colon, breast and prostate as well as to prevent viral diseases that lead to cancers,” said HDT Bio CEO Steve Reed, who is the principal investigator in the collaboration.

“This research builds on an initial collaboration for development of a prostate cancer preventive vaccine targeting tumor-associated antigen expression, part of the NCI’s PREVENT Cancer Preclinical Drug Development Program.  It will involve HDT Bio creating vaccines with saRNA for expression of cancer antigens to stimulate an immune response to kill cancer cells.” said NCI investigator Robert Shoemaker.  Dr. Shoemaker is Chief of the NCI Division of Cancer Prevention’s Chemopreventive Agent Development Research Group. 

The saRNA vaccines will be targeted at a variety of antigens linked to pancreatic, colon, prostate and other cancers. In addition, saRNA vaccines to prevent viral diseases, such as human papilloma virus and hepatitis B, that lead to cancers also will be evaluated.

NCI will perform preclinical studies with the saRNA vaccines in various cancer cell lines and animal models to determine cancer prevention efficacy. Based on the results, the NCI and HDT Bio could collaborate in the future on human clinical trials of the vaccines.

“The antigen-based vaccines,” explained Reed, “could be used as treatment vaccines for cancer patients as well as vaccines to prevent cancer in people diagnosed with specific mutations associated with the different types of the disease. We are very appreciative of this NCI opportunity.”

HDT Bio’s saRNA vaccine technology proved successful in development of a COVID-19 vaccine, which has been authorized in India and is in clinical trials in the U.S., South Korea and Brazil. It is the first saRNA vaccine authorized for human use anywhere in the world.

“Other companies trying to use saRNA have faced challenges because its self-replicating properties can cause excessive stimulation of the innate immune system, resulting in toxic side effects,” Reed said. “It is our proprietary LIONTM system that enables saRNA to work safely.”

HDT Bio’s vaccines are different from commercially available mRNA vaccines. The saRNA is a form of mRNA that amplifies itself inside the body enabling it to activate the immune system at much lower dose levels than mRNA vaccines. That makes HDT Bio’s vaccine not only less expensive to manufacture, but also safer.

In addition, the company’s LIONTM formulation enhances stability of the RNA and does not require the ultra-cold storage of mRNA vaccines. Vaccines built on HDT Bio’s platform can be freeze-dried and stored at simple refrigeration temperatures, significantly reducing the costs and eliminating the barriers for distribution in developing nations. 

HDT Bio is a Seattle-based, clinical-stage biopharmaceutical development company.  With core technology and expertise in nucleic acid formulation, the company develops products that seek to harness host-directed immune responses.  HDT Bio’s work focuses on infectious disease and oncology vaccines and therapeutics through early-stage collaborations with partners worldwide. The company’s vaccine platform, repRNA/LION™, combines formulation and adjuvant ingredients to stabilize and deliver self-amplifying RNA to the immune system to stimulate responses. HDT Bio’s COVID-19 vaccine is the first self-amplifying RNA vaccine to ever receive a regulatory authorization.