JMB2002 / Jemincare - LARVOL DELTA

Safety, tolerability, pharmacokinetics, and immunogenicity of JMB2002-an antibody against COVID-19: a phase 1 clinical trial in healthy Chinese adults. (PubMed, BMC Infect Dis) - "Therefore, JMB2002 was well tolerated after administration of a single dose in the range of 5 mg/kg to 50 mg/kg in healthy Chinese adults."

Clinical • Journal • P1 data • PK/PD data • Allergy • Infectious Disease • Novel Coronavirus Disease • Respiratory Diseases

Structural and biochemical mechanism for increased infectivity and immune evasion of Omicron BA.2 variant compared to BA.1 and their possible mouse origins. (PubMed, Cell Res) - "JMB2002, a therapeutic antibody that was shown to efficiently inhibit Omicron BA.1, also shows potent neutralization activities against Omicron BA.2...The structures of both BA.1 and BA.2 spike trimer bound to mouse ACE2 reveal the basis for their high affinity interactions. Together, these results suggest a possible evolution pathway for Omicron BA.1 and BA.2 variants via a human-cat-mouse-human circle, which could have important implications in establishing an effective strategy for combating SARS-CoV-2 viral infections."

Journal • Preclinical • Infectious Disease • Novel Coronavirus Disease • Respiratory Diseases

Aberrant IKZF1 gene as relapse predictor in standard-risk pediatric patients with B-cell precursor acute lymphoblastic leukaemia. (PubMed, Int J Lab Hematol) - "Our findings support that IKZF1 aberrations are a crucial relapse predictor in standard-risk patients with BCP-ALL, who practically have no significant markers to assess the prognosis during the primary diagnosis."

Journal • Acute Lymphocytic Leukemia • Hematological Malignancies • Leukemia • Oncology • Pediatrics • IKZF1

Structures of the Omicron Spike trimer with ACE2 and an anti-Omicron antibody. (PubMed, Science) - "A broad-spectrum therapeutic antibody, JMB2002, which has completed a Phase 1 clinical trial, maintains neutralizing activity against Omicron. JMB2002 binds to RBD differently from other characterized antibodies and inhibits ACE2 binding."

Journal • Infectious Disease • Novel Coronavirus Disease • Respiratory Diseases

Jemincare group has completed the Phase I clinical trial of its anti-SARS-CoV-2 neutralizing antibody JMB2002 (PRNewswire) - P1, N=40; "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 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....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."

P1 data • Trial completion • Infectious Disease • Novel Coronavirus Disease

Jimin Trust Group Announces Completion of Phase I Clinical Trial of New Crown Neutralizing Antibody [Google translation] (Sina Corp) - "Jimin Trust Group recently announced that its self-developed new coronavirus-specific neutralizing antibody injection (project code: JMB-2002) has completed phase I clinical trials....The clinical trial was designed as a single-center, randomized, double-blind, placebo-controlled, single-dose escalation first phase I trial in humans to evaluate its resistance in healthy subjects."

Trial completion • Infectious Disease • Novel Coronavirus Disease

A human antibody of potent efficacy against SARS-CoV-2 in rhesus macaques showed strong blocking activity to B.1.351. (PubMed, MAbs) - "Furthermore, JMB2002 has demonstrated complete prophylactic and potent therapeutic efficacy in a rhesus macaque disease model. Prophylactic and therapeutic countermeasure intervention of SARS-CoV-2 using JMB2002 would likely slow down the transmission of currently emerged SARS-CoV-2 variants and result in more efficient control of the COVID-19 pandemic."

Clinical • Journal • Infectious Disease • Novel Coronavirus Disease • Respiratory Diseases

US FDA Approved Jemincare to Initiate Clinical Trial of Neutralizing Antibody JMB2002 (PRNewswire) - "On March 31, 2021, Jemincare group announced that their anti-SARS-CoV-2 neutralizing antibody, JMB2002...was approved by FDA for clinical trial in the United States....In the middle of January, 2021, Jemincare has initiated the phase I clinical trial of Chinese healthy subjects. Dosing of all cohorts is completed in the phase I clinical trial in China. Now, JMB2002 was approved by FDA for clinical trial in US, that would add an option for prophylactic and therapeutic intervention of SARS-CoV-2 utilizing JMB2002 to slow down the transmission of currently emerged SARS-CoV-2 variants..."

New trial • Trial status • Infectious Disease • Novel Coronavirus Disease

Jemincare initiates phase I clinical trial of anti-SARS-CoV-2 neutralizing antibody JMB2002 (PRNewswire.co.uk) - "...Jemincare Group, a Chinese pharmaceutical company, announced that it has initiated the phase I clinical trial of anti-SARS-CoV-2 neutralizing antibody (JMB2002). Preclinical studies of JMB2002 including pharmacology and toxicity were carried out systemically. The drug metabolism, safety and efficacy were well performed."

Trial status • Infectious Disease • Novel Coronavirus Disease

Experiment showed that Jemincare's neutralizing antibody JMB2002 would likely keep the potency against the South African mutant (PRNewswire) - "...JMB2002 showed 6.8-fold higher binding affinity to SARS-CoV-2 S1 mutant protein of South African mutant B.1.351. compared to that of S1 prototype. Although, the blocking potency of JMB2002 has 2.8-fold decreased, but still 12-fold higher than that of hACE2-Fc against the South African mutant...Preclinical data indicated that JMB2002 can precisely occupy the key epitope of the receptor binding domain (RBD) on the S1 subunit of the SARS-CoV-2..."

Preclinical • Infectious Disease • Novel Coronavirus Disease