burfiralimab (hzVSF(IgG4)) / Immunemed, Seoul National University Hospital - LARVOL DELTA

Reduction of extracellular vimentin in blood provides protection against SARS-CoV-2 infection. (PubMed, Virulence) - "Quantification of SARS-CoV-2 in the hamsters' lungs revealed that the viral titer in the anti-eVIM-treated groups was 77% to 80% lower than that in the infection group, while remdesivir and the neutralizing antibody resulted in reductions of 41.9% and 34.7% to 44.1%, respectively. We believe that this work provides a foundation for the development of hzVSF-v13 as an antiviral drug for COVID-19."

Journal • Infectious Disease • Inflammation • Novel Coronavirus Disease • Respiratory Diseases • Thrombosis • VIM

Fertility and Early Embryonic Development Toxicity of hzVSF-v13 in Sprague-Dawley Rats. (PubMed, J Appl Toxicol) - "Additionally, hzVSF-v13 did not affect the mating performance, fertility, sperm analysis, or litter parameters in cesarean section at doses up to 100 mg/kg. Under the experimental conditions, the no-observed-adverse-effect level (NOAEL) of hzVSF-v13 for general toxicity, fertility, and early embryonic development was considered to be 100 mg/kg."

Journal • Preclinical • Infectious Disease • Novel Coronavirus Disease

A Study to Assess the Efficacy and Safety of Burfiralimab (hzVSF-v13) and DMRD (Disease-modifying Antirheumatic Drug) (clinicaltrials.gov) - P2 | N=60 | Not yet recruiting | Sponsor: ImmuneMed, Inc.

New P2 trial • Immunology • Inflammatory Arthritis • Rheumatoid Arthritis • Rheumatology

Safety, Tolerability, Pharmacokinetics of hzVSf-v13 in Healthy Adults (Intravenous and Subcutaneous Administration) (clinicaltrials.gov) - P1 | N=72 | Completed | Sponsor: ImmuneMed, Inc. | Recruiting ➔ Completed

Trial completion

Efficacy and Safety of hzVSFv13 in Patients With COVID-19 Pneumonia (clinicaltrials.gov) - P2 | N=1 | Terminated | Sponsor: ImmuneMed, Inc. | N=48 ➔ 1 | Recruiting ➔ Terminated; A new study combining Phase III clinical trials has been planned.

Enrollment change • Trial termination • Infectious Disease • Novel Coronavirus Disease • Pneumonia

A Study to Assess the Efficacy and Safety of Burfiralimab(hzVSF-v13) and OAD (Oral Antiviral Drug) (clinicaltrials.gov) - P2a | N=32 | Recruiting | Sponsor: ImmuneMed, Inc. | Active, not recruiting ➔ Recruiting | N=24 ➔ 32 | Trial completion date: Sep 2023 ➔ Dec 2024 | Trial primary completion date: Jun 2023 ➔ Mar 2024

Combination therapy • Enrollment change • Enrollment open • Monotherapy • Trial completion date • Trial primary completion date • Hepatitis B • Hepatology • Infectious Disease • Inflammation

A Phase IIa Study to Assess the Efficacy and Safety of Burfiralimab(hzVSF-v13) and OAD (Oral Antiviral Drug) (clinicaltrials.gov) - P2a | N=24 | Active, not recruiting | Sponsor: ImmuneMed, Inc.

Combination therapy • Monotherapy • New P2a trial • Hepatitis B • Hepatology • Infectious Disease • Inflammation

Double-Blind, Randomized, Placebo-Controlled Study on hzVSF-v13, a Novel Anti-Vimentin Monoclonal Antibody Drug as Add-on Standard of Care in the Management of Patients with Moderate to Severe COVID-19. (PubMed, J Clin Med) - "Change from baseline of NEWS2 score at day 28 was -3.4 vs. + 0.4 (p = 0.0441). The results propose hzVSF-v13 as a candidate in the treatment of severe COVID-19."

Journal • Infectious Disease • Novel Coronavirus Disease • Pneumonia • Respiratory Diseases • VIM

Efficacy and Safety of hzVSF-v13 in Patients With COVID-19 Pneumonia (clinicaltrials.gov) - P2; N=115; Completed; Sponsor: ImmuneMed, Inc.; Recruiting ➔ Completed

Clinical • Trial completion • Infectious Disease • Novel Coronavirus Disease • Pneumonia • Respiratory Diseases

Efficacy and Safety of hzVSF-v13 in Moderate to Severe Patients With COVID-19 Pneumonia (clinicaltrials.gov) - P2; N=63; Completed; Sponsor: ImmuneMed, Inc.; Recruiting ➔ Completed; Trial completion date: May 2021 ➔ Aug 2021; Trial primary completion date: Apr 2021 ➔ Aug 2021

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

Efficacy and Safety of hzVSFv13 in Patients With COVID-19 Pneumonia (clinicaltrials.gov) - P2; N=48; Recruiting; Sponsor: ImmuneMed, Inc.; Not yet recruiting ➔ Recruiting; Trial completion date: Jul 2021 ➔ Dec 2021; Trial primary completion date: Jun 2021 ➔ Nov 2021

Clinical • Enrollment open • Trial completion date • Trial primary completion date • Infectious Disease • Novel Coronavirus Disease • Pneumonia

For successful IPO, ImmuneMed speeds up antiviral drug development (Korea Biomedical Review) - "ImmuneMed is accelerating efforts to develop hzVSF-v13, an investigational antiviral treatment for chronic hepatitis B, and pushing to go public on Kosdaq this year...won regulatory approval for its plan for phase-2a trial of hzVSF-v13 to treat chronic hepatitis B...The phase-2a study will occur at Samsung Medical Center, the Seoul National University Hospital, and the Severance Hospital. ImmuneMed said it would begin the first administration in June at the earliest."

Regulatory • Trial initiation date • Hepatitis B • Infectious Disease

News on business agreements such as NG Chem Life Science, Immunmed, Media Age, etc. [Google translation] (BioTimes) - "Immunmed researchers confirmed that hzVSF-v13 was effective when applied to Idiopathic Pulmonary Fibrosis (IPF)..."

Preclinical • Idiopathic Pulmonary Fibrosis

Safety, Tolerability, Pharmacokinetic Characteristics of hzVSF-v13 in Healthy Male Volunteers (clinicaltrials.gov) - P1; N=56; Completed; Sponsor: ImmuneMed, Inc.; Enrolling by invitation ➔ Completed

Trial completion

Safety, Tolerability, Pharmacokinetics of hzVSf-v13 in Healthy Adults (Intravenous and Subcutaneous Administration) (clinicaltrials.gov) - P1; N=72; Recruiting; Sponsor: ImmuneMed, Inc.

Clinical • New P1 trial

Study with hzVSF-v13 in patients with COVID-19 pneumonia: a phase II, proof of concept, multicentre, randomized, parallel-group, double-blind, placebo-controlled study Studio con hzVSF-v13 somministrato per via endovenosa in pazienti affetti da polmonite da COVID-19: studio proof of concept di fase II, multicentrico, randomizzato, a gruppi paralleli, in doppio cieco, controllato verso placebo (clinicaltrialsregister.eu) - P2; N=105; Ongoing; Sponsor: ImmuneMed Inc.

Clinical • New P2 trial • Infectious Disease • Novel Coronavirus Disease • Pneumonia • Respiratory Diseases • CRP • IL6 • TNFA

Efficacy and Safety of hzVSF-v13 in Moderate to Severe Patients With COVID-19 Pneumonia (clinicaltrials.gov) - P2; N=63; Recruiting; Sponsor: ImmuneMed, Inc.; Not yet recruiting ➔ Recruiting

Clinical • Enrollment open • Infectious Disease • Novel Coronavirus Disease • Pneumonia

ImmuneMed’s hzVSF-v13, COVID-19 clinical trials accelerate development of the treatment (PRNewswire) - "Followed by Russia, Indonesia, and Korea, the second phase of the COVID-19 clinical trial was approved in Italy...It is expected to see the results sequentially starting as early as the third quarter of 2021....Another Phase 1 clinical trial is under way in Australia. ImmuneMed carried forward with the Phase 2 clinical trial after analyzing the results of Phase 1 study and compassionate use of hzVSF-v13 against COVID-19....Although there will be differences in clinical studies among countries, the company plans to finalize all the Phase 2 clinical studies by sometime next year....ImmuneMed is preparing IND application to FDA and is aiming to initiate the Phase 2 clinical study within the first half of 2021."

IND • New P2 trial • P2 data • Trial status • Infectious Disease • Novel Coronavirus Disease

Efficacy and Safety of hzVSFv13 in Patients With COVID-19 Pneumonia (clinicaltrials.gov) - P2; N=48; Not yet recruiting; Sponsor: ImmuneMed, Inc.

Clinical • New P2 trial • Infectious Disease • Novel Coronavirus Disease • Pneumonia

Efficacy and Safety of hzVSF-v13 in Moderate to Severe Patients With COVID-19 Pneumonia (clinicaltrials.gov) - P2; N=63; Not yet recruiting; Sponsor: ImmuneMed, Inc.

Clinical • New P2 trial • Infectious Disease • Novel Coronavirus Disease • Pneumonia

Efficacy and Safety of hzVSF-v13 in Patients With COVID-19 Pneumonia (clinicaltrials.gov) - P2; N=105; Recruiting; Sponsor: ImmuneMed, Inc.

Clinical • New P2 trial • Infectious Disease • Novel Coronavirus Disease • Pneumonia • Respiratory Diseases

Covid-19 new drug in South Korea ImmuneMed develops antiviral agent VSF for trial by government (GeneOnline) - "Results of the first phase clinical trial of HzVSFv13 in VSF preparations recently conducted by Seoul University were used to confirm safety, drug tolerance and pharmacokinetic data in healthy men....Clinical trial application of VSF drug has also been approved by the Korea Food and Drug Administration for use in patients with COVID-19....The course of VSF will be divided into four time points and administered to patients with coronavirus infection on days 1, 3, 7, and 10 respectively."

Clinical protocol • Non-US regulatory • P1 data