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The result surprised many people. Dr. Phillip Pang, chief medical officer of
Vir Biotechnology, said in a press release that based on the results of preclinical studies, they expected to see the same magnitude of decline in surface antigens of HBV at much higher doses, "not at all expected to achieve this result in a dose of 6 mg."
previous data, the hepatitis B therapy, called VIR-3434, has a maximum to-dosage of up to 3,000 mg among healthy volunteers.
VIR-3434 is a monoclonal antibody that mediates the hepatitis B virus, inhibits all 10 subtypes of HBV from entering liver cells, and reduces viral and subviral particles in the blood.
but it's not just a simple monoclonal antibody.
Fc fragment of its antibody has been modified with a special "vaccine mutation," according to Vir Biotechnology's website.
this mutation is expected to convert common antibodies into T-cell vaccines, inducing the production of protective adaptive immunity.
last October, this novel idea received a preliminary proof of concept.
scientists at Rockefeller University and Vir Biotechnology teamed up to publish a paper in the journal Nature that the protective immune response could be enhanced if the Fc domain was enhanced to bind to congenital immune cell Fc receptors.
this may be related to the activation of degeneration cells and antiviral effect T cells.
because it involves adaptive immunity, the researchers note, it may have long-term immune effects.
antibodies with vaccine properties are also expected to be important therapies for infectious diseases.
today's data add clinical support to this type of therapy.
this is a randomized, placebo-controlled Phase 1 clinical trial designed to assess the safety, toerability, pharmacodynamics, antiviral and immunomodulation activity of VIR-3434.
preliminary data came from eight volunteers (six who received the drug and two who received a placebo).
8 days after receiving a single 6 mg VIR-3434 injection, the six volunteers who received the drug had an average reduction of 1.3 log10 IU/mL in serum hepatitis B virus surface antigens.
Vir Biotechnology will continue to conduct phase 1 clinical trials of VIR-3434 in the hope of generating proof-of-concept data quickly.
data will also be presented at a follow-up medical conference.
other hand, phase 2 clinical trials of VIR-3434 in combination with VIR-2218, an RNAi therapy for hepatitis B, are also expected to begin in the second half of this year.
the drug Mingkang content team will continue to track the follow-up progress, stay tuned.
: This article is intended to introduce medical and health research, not treatment options recommended.
if you need guidance on treatment options, visit a regular hospital.
: s1. Initial Data From Ongoing Phase 1 Trial of VIR-3434 for Chronic Hepatitis B Virus Virus Application Project Larges and Rapid Reduction in Hepatitis B Surface Antigen, Retrieved January 26th, 2021, from