Jemincare group has completed the Phase I clinical trial of its anti-SARS-CoV-2 neutralizing antibody JMB2002
PR91645
SHANGHAI, Sept. 14, 2021 /PRNewswire=KYODO JBN/ --
Recently, Jemincare group has declared that it has completed phase I clinical
trial of self-developed novel coronavirus specific neutralizing antibody
(Project code: JMB2002).
The clinical trial of JMB2002 was stated in January 2021. A single-center,
randomized, double-blind, placebo-controlled, single-dose escalation phase I
trial was designed to evaluate JMB2002's tolerability, safety, pharmacokinetic
characteristics and immunogenicity in healthy subjects. In this study, 40
subjects were enrolled in 4 dose groups from low to high. All 40 participants
have completed the entire trial. The results have shown that only one subject
underwent grade 2 adverse events (TEAE) related to the study drug. The other
TEAEs were all in grade 1, and all TEAEs were in remission or completely
recovered. None of the subjects had any serious adverse events (SAE) related to
the study drug.
In terms of pharmacokinetics, after a single intravenous infusion of JMB2002,
the Cmax and AUC elevated with the increasing of dosage, and the Tmax decreased
with the increasing of dosage. There were no significant changes in the
parameters like T1/2, Vz, CLz, λz and MRT among different dose groups. In
terms of drug immunogenicity, anti-drug antibody was detected in only 1 subject
before and after administration of the drug, while no anti-drug antibodies were
detected in all the other subjects.
According to the results of phase 1 clinical study, JMB2002 is worthy of
further exploration of clinical efficacy study in patients with COVID-19 virus
infection, in order to contribute to the treatment of COVID-19 in the world.
To deal with the challenge of viral escape, Jemincare is continuing to develop
new broad-spectrum neutralizing antibodies against SARS-CoV-2. To date, R & D
team has obtained second generation neutralizing antibodies with better
neutralizing activity against all variants of concern including the Alpha,
Beta, Gamma and Delta variants in pseudo-virus neutralizing assay. Furthermore,
these antibodies could be developed as a cocktail therapy that provide more
options for the control of global COVID-19 pandemic and prevent the
immune-escape of SARS-CoV-2 virus, as they recognize different epitope bins of
SARS-CoV-2 S1.
As early as the outbreak of the COVID-19 pandemic, Jemincare R & D team has
efficiently isolated the neutralizing antibody JMB2002 targeting SARS-CoV-2 RBD
from a naïve human antibody library containing over 10^10 clones. Based on
Phage-to-Yeast (PtY) antibody discovery platform, a novel competitive FACS
approach was developed during the high-throughput screening step. That is, the
library was incubated with SARS-CoV-2 S1 RBD and hACE2 protein which led to the
maximum simulation of hACE2 by the antibody. The fully human anti-SARS-CoV-2
neutralizing antibody was obtained in only 19 days using PtY platform.
PtY antibody discovery platform has the advantages of high-throughput and real
time visualized multidimensional screening. It rapidly and precisely screened
out antibody candidates recognizing desired epitopes against targets, that
dramatically shortened time in early discovery stage. Based on PtY and other
antibody discovery platforms, biologics institute of Jemincare group has built
up a portfolio of more than 10 clinical and pre-clinical stage antibody
projects focusing on kidney, tumor, asthma and anti-infectious disease areas to
benefit thousands of patients in the near future.
SOURCE Jemincare
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Caption: Jemincare PtY antibody discovery platform
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