SEATTLE & SEOUL, South Korea--(BUSINESS WIRE)--HDT Bio Corp., a developer of immunotherapies for oncology and infectious diseases, and Korean biotech Quratis Inc. announced today 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.
“There is a continuing global gap in equitable distribution of COVID-19 vaccines,” said HDT Bio CEO Steve Reed. “Central manufacturing of the vaccines has resulted in the populations of richer nations being vaccinated at a much higher rate than the rest of the world. Successful development of HDT Bio’s vaccine will enable Quratis to manufacture our next-generation COVID-19 RNA vaccine and make it available across much of East Asia.”
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.
Currently, Quratis is operating a fully equipped GMP plant, which produces DNA plasmid, RNA, enzyme, protein, and other bio products. Their Fill & Finish capacity is 50 million vials a year and is being expanded up to 200 million vials a year by the end of next year. 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.
ABOUT HDT BIO CORP.
HDT Bio is a Seattle-based 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’s work focuses on oncological and infectious disease applications. HDT Bio’s founders are world leaders in the development of immune stimulants, including both therapeutics and therapy-enhancing adjuvants. One of the company’s core technologies, RNA/LION™, combines formulation and adjuvant ingredients to stabilize and deliver RNA to the immune system to stimulate responses for therapy or vaccination. http://hdt.bio
ABOUT QURATIS INC.
Established in 2016, Quratis is a biotech company developing vaccines for tuberculosis and other infectious diseases with advanced technologies in adjuvant and antigen discovery. Its technology also includes peptide nucleic acid-based antimicrobial agents which are being developed to treat multi-drug resistant tuberculosis, Staphylococcus aureus infections and cancer. Having recently built cutting-edge GMP-level facilities, Quratis now takes on a leadership role in research, development, and manufacturing. For more information, please visit http://www.quratis.com.
