HDT Bio’s COVID-19 Vaccine Wins Regulatory Approval in India

Next-generation RNA technology can be safer, more effective at lower doses than current mRNA COVID-19 vaccines

Proprietary LION^TM delivery system provides stability at refrigerator temperature

SEATTLE--(BUSINESS WIRE)--Indian regulators have issued an Emergency Use Approval for Gemcovac, a groundbreaking COVID-19 vaccine based on the technology of Seattle biotech HDT Bio Corp. The vaccine uses self-amplifying RNA (or “saRNA”), which replicates itself following administration and is thus effective at extremely low doses. In addition, it is stable at refrigerator temperatures—unlike current mRNA vaccines, which require ultra-cold storage.

“Our saRNA vaccine is a game changer,” said HDT Bio CEO Steve Reed. “This technology can stimulate an immune response with a dose of up to 20 times lower than current vaccines, which enhances safety, lowers costs, and increases production speed. Also, the vaccine can be transported at refrigerator temperature, or even freeze-dried and shipped without temperature control. The combination of lower cost and higher stability will allow HDT Bio to take a truly global distribution approach.”

With today’s action by Indian regulators, Gemcovac becomes the first saRNA vaccine ever approved for human use. HDT Bio’s vaccine is currently undergoing clinical trials in the U.S., Brazil, and South Korea.

“Pandemics can't be stopped without global access to quality vaccines. We are very excited that our vaccine will soon be saving lives, including in countries that have previously had limited access to advanced vaccine technologies,” said Reed. “This milestone is the first of our many efforts to improve global health outcomes through scientific advancement.”

ABOUT HDT BIO CORP.

HDT Bio is a biopharmaceutical company dedicated to providing immunotherapies to people around the world, including those in historically underserved areas. The company seeks to harness the body’s immune system to deliver therapies that narrowly target the specific areas of the body where they are needed. HDT Bio’s work focuses on oncological and infectious disease applications.