plonmarlimab (TJM2) / I-Mab - LARVOL DELTA

Plonmarlimab, a novel anti-GM-CSF blocking antibody, ameliorates disease progression in the pre-clinical model of macrophage activation syndrome. (PubMed, Immunology) - "Plonmarlimab is a highly potent GM-CSF blocking antibody and has demonstrated promising efficacy in a pre-clinical MAS model with a favourable safety profile, supporting its clinical development."

Journal • Preclinical • Hematological Disorders • Inflammation • CSF2 • STAT5

A Study of TJ003234 in Rheumatoid Arthritis Patients (clinicaltrials.gov) - P1 | N=63 | Recruiting | Sponsor: I-Mab Biopharma Co. Ltd. | Trial completion date: Mar 2022 ➔ Mar 2023 | Trial primary completion date: Mar 2022 ➔ Mar 2023

Trial completion date • Trial primary completion date • Immunology • Inflammatory Arthritis • Rheumatoid Arthritis • Rheumatology

Study of TJ003234 (Anti-GM-CSF Monoclonal Antibody) in Subjects With Severe Coronavirus Disease 2019 (COVID-19) (clinicaltrials.gov) - P2/3 | N=152 | Completed | Sponsor: I-Mab Biopharma Co. Ltd. | Recruiting ➔ Completed | N=384 ➔ 152

Enrollment change • Trial completion • Infectious Disease • Novel Coronavirus Disease • Respiratory Diseases

Study of TJ003234 (Anti-GM-CSF Monoclonal Antibody) in Subjects With Severe Coronavirus Disease 2019 (COVID-19) (clinicaltrials.gov) - P2/3; N=384; Recruiting; Sponsor: I-Mab Biopharma Co. Ltd.; Active, not recruiting ➔ Recruiting

Enrollment open • Infectious Disease • Novel Coronavirus Disease • Respiratory Diseases • PCR

Study of TJ003234 (Anti-GM-CSF Monoclonal Antibody) in Subjects With Severe Coronavirus Disease 2019 (COVID-19) (clinicaltrials.gov) - P2/3; N=384; Active, not recruiting; Sponsor: I-Mab Biopharma Co. Ltd.; Recruiting ➔ Active, not recruiting

Enrollment closed • Infectious Disease • Novel Coronavirus Disease • Respiratory Diseases • PCR

Cartilage Oligomeric Matrix Protein Responses to a Mechanical Stimulus Associate with Ambulatory Loading in Individuals with Anterior Cruciate Ligament Reconstruction. (PubMed, J Orthop Res) - "Twenty-five subjects (mean age: 34.5±9.8 years; 2.2±0.2 years post-surgery) with primary unilateral ACL reconstruction underwent gait analysis for assessment of peak vGRF and TJM first (TJM1) and second (TJM2) peaks...These results demonstrate that higher TJM and vGRF in the ACLR limb as compared to the contralateral limb are associated with higher relative COMP levels 3.5-hours and 5.5-hours after a 30-minute walk. Future work should investigate the effect of therapies to alter joint loading on the biological response in individuals after ACL reconstruction."

Clinical • Journal • Immunology • Osteoarthritis • Pain • Rheumatology

Repurposed Drugs, Molecular Vaccines, Immune-Modulators, and Nanotherapeutics to Treat and Prevent COVID-19 Associated with SARS-CoV-2, a Deadly Nanovector. (PubMed, Adv Ther (Weinh)) - "Many emerging nanotechnology-based interventions will be critical in the fight against the deadly virus by facilitating early detection and enabling target oriented multidrug therapeutics. The therapeutic candidates discussed in this article include remdesivir, dexamethasone, hydroxychloroquine, favilavir, lopinavir/ritonavir, antibody therapeutics like gimsilumab and TJM2, anti-viral nanoparticles, and nanoparticle-based DNA and mRNA vaccines."

Journal • Review • Immune Modulation • Infectious Disease • Inflammation • Novel Coronavirus Disease • Respiratory Diseases

Targeting GM-CSF in COVID-19 Pneumonia: Rationale and Strategies. (PubMed, Front Immunol) - "Initial findings from patients with COVID-19 treated with a single intravenous dose of mavrilimumab, a monoclonal antibody binding GM-CSF receptor α, showed oxygenation improvement and shorter hospitalization. Anti-GM-CSF monoclonal antibodies, TJ003234 and gimsilumab, will be tested in clinical trials in patients with COVID-19, while lenzilumab received FDA approval for compassionate use. These trials will help inform whether blunting the inflammatory signaling provided by the GM-CSF axis in COVID-19 is beneficial."

Journal • Review • Immune Modulation • Immunology • Infectious Disease • Inflammation • Novel Coronavirus Disease • Pneumonia • Respiratory Diseases

I-Mab Reports Financial Results for Full Year of 2020 and Provides Business Updates (BioSpace) - "SLE: The Company is awaiting IND approval by the NMPA and a phase 1b trial in patients with SLE will be initiated 2H 2021 in China....Cytokine release syndrome associated with severe COVID-19: I-Mab is conducting a phase 2 clinical trial with plonmarlimab for the treatment of cytokine release syndrome associated with severe and critically ill COVID-19 patients [NCT04341116] to potentially save lives of patients with severe COVID-19. The clinical trial has progressed to the second part, aiming to evaluate the efficacy, safety and cytokine levels following a single dose of plonmarlimab at 6 mg/kg or placebo (best supportive care) in patients with severe COVID-19. An interim analysis is planned in Q2 2021."

Cytokine release syndrome • New P1 trial • P2 data • Trial status • Infectious Disease • Novel Coronavirus Disease • Systemic Lupus Erythematosus

Study of TJ003234 (Anti-GM-CSF Monoclonal Antibody) in Subjects With Severe Coronavirus Disease 2019 (COVID-19) (clinicaltrials.gov) - P2/3; N=384; Recruiting; Sponsor: I-Mab Biopharma Co. Ltd.; Phase classification: P1b/2 ➔ P2/3; N=144 ➔ 384; Trial completion date: Dec 2020 ➔ Dec 2021; Trial primary completion date: Dec 2020 ➔ Dec 2021

Clinical • Enrollment change • Phase classification • Trial completion date • Trial primary completion date • Infectious Disease • Novel Coronavirus Disease • PCR

Study of TJ003234 (Anti-GM-CSF Monoclonal Antibody) in Subjects With Severe Coronavirus Disease 2019 (COVID-19) (clinicaltrials.gov) - P1b/2; N=144; Recruiting; Sponsor: I-Mab Biopharma Co. Ltd.; Trial completion date: Sep 2020 ➔ Dec 2020; Trial primary completion date: Sep 2020 ➔ Dec 2020

Clinical • Trial completion date • Trial primary completion date • Infectious Disease • Novel Coronavirus Disease • PCR

IMAB (IMAB) Q2 2020 Earnings Call Transcript (The Motley Fool) - "TJM2 our anti-GM-CSF antibody is currently being evaluated for its role in the treatment of cytokine release syndrome associated with severe COVID-19....Now in addition, we recently initiated a Phase 1b study with TJM2 in patients with rheumatoid arthritis."

Trial status • Immunology

I-Mab Reports Financial Results for the Six Months Ended June 30 and Provides Corporate Update (Yahoo Finance) - "The Company expects multiple data readouts across a progressing pipeline in the coming months....Part 2 clinical update from plonmarlimab in patients with cytokine release syndrome associated with severe COVID-19....The Company is currently in discussion with the FDA to finalize the plan for TJM2 in relation to clinical development and potential registration in the U.S."

Cytokine release syndrome • P2 data • Infectious Disease • Novel Coronavirus Disease

I-Mab Announces First Patient Dosed in Phase 1b Study of Plonmarlimab in Rheumatoid Arthritis in China (PipelineReview) - "A Phase 2 trial to treat patients with cytokine release syndrome associated with COVID-19 is currently in progress in the US."

Cytokine release syndrome • Trial status • Infectious Disease • Novel Coronavirus Disease

A Study of TJ003234 in Rheumatoid Arthritis Patients (clinicaltrials.gov) - P1; N=63; Recruiting; Sponsor: I-Mab Biopharma HongKong Limited; Not yet recruiting ➔ Recruiting

Clinical • Enrollment open • Immunology • Rheumatoid Arthritis • Rheumatology

A Study of TJ003234 in Rheumatoid Arthritis Patients (clinicaltrials.gov) - P1; N=63; Not yet recruiting; Sponsor: I-Mab Biopharma HongKong Limited

Clinical • New P1 trial • Immunology • Rheumatoid Arthritis • Rheumatology

In Peoria, clinical trials and a new medicine are bringing hope to the sickest Covid-19 patients (Star Courier) - "St. Francis is one of several hospitals across the country participating in the clinical trial to determine if the drug, currently known as TJ003234, is a safe and effective treatment for COVID-19....The trial...is in an early stage, where just a few patients have been given the drug to make sure it is safe, said Kim. Once safety is determined, it will be administered to more patients, and results will be recorded to determine if it is helping."

Clinical • Cytokine storm • Infectious Disease • Novel Coronavirus Disease

I-MAB advances repositioned RA drug in early trial to treat Covid-19 cytokine storm (FierceBiotech) - "Studies of COVID-19 patients have documented high levels of both GM-CSF and IL-6 in the bloodstream of those who become severely ill....I-MAB’s executives said during the call that if the results of part two of the TJM2 study in COVID-19 are positive, it will consult with the FDA to develop a plan to speed the drug to market. The company is also accelerating a manufacturing plan to ensure it will have enough of the drug for further clinical trials..."

Cytokine release syndrome • FDA event • Infectious Disease • Novel Coronavirus Disease

I-Mab reports interim results from part 1 study for anti-GM-CSF antibody TJM2 to treat Covid-19 patients with -cytokine release syndrome (PRNewswire) - P1/2, N=114; NCT04341116; Sponsor: I-Mab Biopharma; "I-Mab...today announced interim results....Part 1 of the study evaluated the safety and tolerability of TJM2 in a total of 24 patients...After comprehensive review and analysis, the DMC concluded that I-Mab can commence the Part 2 of the study as planned, indicating TJM2 is safe and well-tolerated in the severe COVID-19 patients in the study. The DMC also endorsed protocol changes....Part 2 of the study with a similar design to Part 1 will target the same patient population and is expected to be initiated shortly."

Cytokine release syndrome • DSMB • P1 data • Infectious Disease • Novel Coronavirus Disease

Study of TJ003234 (Anti-GM-CSF Monoclonal Antibody) in Subjects With Severe Coronavirus Disease 2019 (COVID-19) (clinicaltrials.gov) - P1b/2; N=144; Recruiting; Sponsor: I-Mab Biopharma Co. Ltd.; Not yet recruiting ➔ Recruiting

Clinical • Enrollment open

I-Mab announces IND clearance from FDA for TJM2 to treat Cytokine Release Syndrome (CRS) associated with severe coronavirus disease 19 (COVID-19) (GlobeNewswire) - "I-Mab...today announced that the U.S. Food and Drug Administration (FDA) has cleared the Company's Investigational New Drug application (IND) to initiate clinical study for TJM2....The Company has also obtained central institutional review board (IRB) approval from the Western Institutional Review Board on the same day....The proposed clinical trial is a multi-center, randomized, double-blind, placebo-controlled, three-arm study....'We are preparing for clinical trial initiation in the U.S'....I-Mab has plans to expand the study into other hard-hit countries."

IND • New trial

I-Mab to test anti-inflammatory for cytokine release syndrome in Covid-19 patients (ChinaBio Today) - "I-Mab...has started to develop TJM2 (TJ003234) to treat cytokine release syndrome in severe cases of COVID-19....I-Mab intends to start clinical trials in the US and expand to countries especially hard-hit by COVID-19."

New trial