SHANGHAI, Sept. 14, 2021 /PRNewswire/ — 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 1010 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.