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