Walvax and Abogen Announce Safety and Immunogenicity Data from Phase 1 Clinical Study of AWcorna (SARS-CoV-2 mRNA Vaccine) Published in The Lancet Microbe
February 7, 2022, Kunming — Walvax Biotechnology Co., Ltd. (“Walvax”, 300142.SZ) and Suzhou Abogen Biosciences Co., Ltd. (“Abogen”) announced the publication of results from the phase 1 clinical study of the Walvax-Abogen COVID-19 vaccine (AWcorna, previously referred to as ARCoV or ARCoVax), demonstrating the promising immunogenicity and acceptable safety of the candidate vaccine. This study, registered with www.chictr.org.cn (ChiCTR2000039212), which builds on preclinical findings, was to evaluate the tolerability and preliminary immunogenicity in 120 participants who received two doses of AWcorna or placebo with 28 days apart. The results were published in The Lancet Microbe on January 24, 2022 (See full text on https://www.thelancet.com/journals/lanmic/article/PIIS2666-5247(21)00280-9/fulltext). Key findings of the phase 1 clinical study are shown below:
Acceptable tolerability and safety: Common and similar adverse reactions were observed following each dose, including fever, fatigue/malaise, headache, pain or redness at injection site, etc. Most reported adverse reactions were mild or moderate in severity and about 95% resolved in the first 2 days following vaccination. No serious adverse events occurred during this trial.
Potent humoral immunogenicity: Peak titre of neutralising antibodies against live SARS-CoV-2 was detected in the 15 μg group 15 days after second vaccination and the geometric mean titre was about twofold higher than that of a panel of convalescent sera from COVID-19 patients, showing promising efficacy.
Promising cellular immunogenicity: Strong T-helper-1-cell response dominated by production of IL-2 and IFN-γ expressing cells was induced in most participants after a 2-dose regimen with various doses, implicating the potential of combating SARS-CoV-2 infection and also the contribution to reduced risk of vaccine-associated antibody dependent enhancement of virus replication.
AWcorna is a SARS-CoV-2 mRNA vaccine developed by Suzhou Abogen Biosciences Co., Ltd. with the participation of Yuxi Walvax Biotechnology Co., Ltd. The vaccine is served in 0.5 mL prefilled syringe, with mRNA encoding the RBD of the spike glycoprotein (S protein) of SARS-CoV-2 as the active substance. AWcorna can be stored and transported at 2℃ to 8℃ with protection from light.
Founded in 2001, Walvax Biotechnology Co., Ltd. (Walvax) is a leading vaccine producer, engaged in research and development, manufacturing and distribution of safe and efficacious quality vaccines. Headquartered in China’s southwestern city Kunming in Yunnan Province, Walvax went to IPO in 2010 (300142.SZ) and started business expansion from traditional vaccines to innovative vaccines. With the vision of dedicating to be the pride domestically and the pioneer globally in the vaccine industry, producing efficacious, quality, innovative and affordable products to protect people from the world’s deadliest diseases, Walvax’s purpose is to help everyone live a healthy life.
Abogen is a clinical-stage biotechnology company focused on advancing mRNA-based therapeutics for the treatment of cancer and other infectious diseases. Since its establishment in January 2019, Abogen has developed its own mRNA technology platform and proprietary delivery system which empowers the development of a series of drug product candidates including vaccines for infectious diseases and therapies for cancer.