14 December 2021 | News
HDT’s RNA-based vaccine offers simpler manufacturing, greater stability, and vastly lower effective dosing than current mRNA COVID-19 vaccines
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HDT Bio Corp., a US-based developer of immunotherapies for oncology and infectious diseases, and Korean biotech Quratis Inc. have announced that the first healthy volunteers in South Korea have been dosed in a Phase 1 trial of HDT Bio’s revolutionary COVID-19 RNA vaccine for distribution in South Korea and neighboring countries.
HDT has similar collaborations with Gennova Biopharmaceuticals in India, SENAI CIMATEC in Brazil and with a fourth company in China.
Quratis is developing HDT Bio’s RNA vaccine under the name QTP104. The Phase 1 study is a randomized, open label, dose-escalation trial to evaluate safety, reactogenicity and immunogenicity in 36 healthy adults at three dose levels, 1 ug, 5 ug and 25 ug. Twelve subjects will be enrolled at each dose level.
Once QTP104 is approved, Quratis will produce the second-generation RNA vaccine in their plant to contribute to global healthcare.
HDT Bio’s COVID-19 vaccine uses its proprietary LION™ formulation to deliver immune-stimulating RNA fragments to targeted cells. The vaccine is significantly different from current mRNA vaccines in two ways. First, its RNA payload is designed to amplify itself inside the body. As a result, the vaccine effectively activates the immune system at a much lower dose than current vaccines, enhancing safety and reducing manufacturing costs. Second, the LION™ formulation system simplifies manufacturing and enhances stability.