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hzVSF v13

Drug Profile

hzVSF v13

Alternative Names: hzVSF-v13

Latest Information Update: 28 Apr 2020

At a glance

  • Originator ImmuneMed
  • Developer ImmuneMed; Lonza
  • Class Anti-inflammatories; Antivirals; Immunoglobulins; Monoclonal antibodies; Proteins
  • Mechanism of Action Virus replication inhibitors
  • Orphan Drug Status

    Orphan designation is assigned by a regulatory body to encourage companies to develop drugs for rare diseases.

    No
  • New Molecular Entity Yes
  • Available For Licensing Yes

Highest Development Phases

  • Phase I Viral infections
  • Clinical Phase Unknown COVID 2019 infections
  • Preclinical Coronavirus infections; Herpesvirus infections
  • No development reported Hepatitis B; Hepatitis C; Influenza virus infections

Most Recent Events

  • 28 Apr 2020 No recent reports of development identified for preclinical development in Hepatitis-B in South Korea (IV)
  • 28 Apr 2020 No recent reports of development identified for preclinical development in Hepatitis-B in United Kingdom (IV)
  • 28 Apr 2020 No recent reports of development identified for preclinical development in Hepatitis-C in South Korea (IV)

Development Overview

Introduction

A humanised virus suppressing factor variant 13, designated as hzVSF v13, is being developed by ImmuneMed, for the treatment of viral infections caused by influenza virus, herpes virus, encephalomyocarditis (EMC) virus causing diabetes mellitus, hepatitis B and hepatitis C virus, COVID-2019 infections. Clinical development is ongoing in South Korea and preclinical development for hepatitis B, coronavirus infections, hepatitis C, herpesvirus infections and influenza virus infections underway in South Korea and the United Kingdom. The drug is approved for compassionate use in South Korea for COVID-2019 infections.

hzVSF v13 is an endogenous broad-spectrum antiviral and a monoclonal antibody immunoglobulin G4 (IgG4), developed using ImmuneMed's antibody and antigen discovery technologies. The antibody discovery platform enables the company to develop and discover antibodies with specificity for particular serotypes, species, and genera. The antigen discovery technology is used for discovering of both serotype-specific and group-specific antigens. The hzVSF reacts to VSF receptor (VR), a protein that is expressed only on virus-infected cells. HzVSF acts as a ligand to VR, and once engaged, it inhibits viral proliferation and suppresses infection-related inflammation that affects cell signaling pathways.

As of September 2018, ImmuneMed is seeking partners for licensing-out the drug for progressing the development (ImmuneMed website, September 2018).

As at April 2020, no recent reports of development had been identified for preclinical development in Hepatitis-B in South Korea (IV), United Kingdom (IV), preclinical development in Hepatitis-C in United Kingdom (IV), South Korea (IV), preclinical development in Influenza-virus-infections in South Korea (IV), United Kingdom (IV), preclinical development in Viral-infections in United Kingdom (IV).

Company Agreements

In December 2011, Lonza entered into a research and development agreement with ImmuneMed Inc, for the in silico screening followed by de-immunisation of their virus suppressing factor (VSF), being developed for the treatment of viral infections, including encephalomyocarditus, influenza virus and hepatitis. Under the terms of the agreement, Lonza will perform an immunogenicity risk assessment using their latest version of their T-cell epitope prediction engine, Epibase™. The preclinical assessment will be performed at Lonza's protein services and development facility in the UK. [1]

Key Development Milestones

In March 2020, The Korean Ministry of Food and Drug Safety (MFDS) approved the use of hzVSF v13 for COVID-19 treatment for individual patient at Yonsei University Hospital. The application for treatment use is the compassionate use system allowing doctors or companies to apply for and receive approval from the MFDS for individual or multiple patients who do not have an alternative treatment. Earlier, the two pneumonia patients who were administered the drug were given 2 or 3 doses of hzVSF and within 10 days, the virus disappeared and their pneumonia improved, eventually making a full recovery. Three patients had severe conditions requiring ventilator and ECMO treatment due to deteriorating pneumonia despite prescribing Kaletra, but showed rapid improvement after hzVSF administration. No side effects associated with VSF have been reported in these 7 pneumonia patients [2] .

In November 2018, ImmuneMed initiated a phase I trial to assess the safety, tolerability and pharmacokinetics of hzVSF-v13 in volunteers (IM_hzVSF_v13-0001; NCT03653208). The randomised, double-blind, placebo controlled, dose-escalation study intends to enrol approximately 56 healthy adults in South Korea [3] . There was no serious adverse event up to the highest dose of 1,200 mg [2] .

In March 2020, ImmunoMed released preclinical data for coronavirus infections [2] .

In animal models, hzVSF inhibited pathological activity and improved clinical symptoms.

Lonza will carry out preclinical immunogenicity risk assessment using its T-cell epitope prediction engine, Epibase™, at its protein services and development facility in the UK. Epibase is designed to predict and compare the immunogenicity risk potential of protein leads based on T-cell epitope content. The data generated from screening will then be used for de-immunization of hzVSF v13.

Patent Information

In April 2009, the USPTO granted an US patent number US 7 514 082 B2 to ImmuneMed, entitled "Anti-viral VSF protein and hybridoma producing the same", related to a virus suppressing factor (VSF) protein having antiviral activity against various viruses and a hybridoma secreting such a VSF protein. The patent is related to a pharmaceutical composition comprising the VSF protein and a method for prevention or treatment of viral infections in humans and animals, using such a pharmaceutical composition.

ImmuneMed has a pending US patent application number US 20 050 080 236 A1, entitled "Novel anti-viral VSF protein and hybridoma producing the same", related to a virus suppressing factor (VSF) protein having antiviral activity against various viruses and a hybridoma secreting such a VSF protein. The patent is related to a pharmaceutical composition comprising the VSF protein and a method for prevention or treatment of viral infections in humans and animals, using such a pharmaceutical composition. The patent was filed in April 2005.

In March 2004, ImmuneMed was granted a Korean patent number 0425030, entitled "Novel anti-viral VSF protein and hybridoma producing the same", related to a virus suppressing factor (VSF) protein having antiviral activity against various viruses and a hybridoma secreting such a VSF protein.

ImmuneMed has a pending patent application number WO 03 064 461 A1, entitled "Novel anti-viral VSF protein and hybridoma producing the same", related to a virus suppressing factor (VSF) protein having antiviral activity against various viruses and a hybridoma secreting such a VSF protein. The patent was filed in August 2003.

Drug Properties & Chemical Synopsis

  • Route of administration IV
  • Formulation Injection, unspecified
  • Class Anti-inflammatories, Antivirals, Immunoglobulins, Monoclonal antibodies, Proteins
  • Target Virus replication
  • Mechanism of Action Virus replication inhibitors
  • WHO ATC code

    J05 (Antivirals for Systemic Use)

    J05A-P (Antivirals for treatment of HCV infections)

  • EPhMRA code

    J5 (Antivirals for Systemic Use)

    J5B1 (Viral hepatitis products)

    J5B3 (Herpes antivirals)

    J5B4 (Influenza antivirals)

Development Status

Summary Table

Indication Qualifier Patient Segment Phase Countries Route / Formulation Developers Event Date
COVID 2019 infections Compassionate use - Clinical Phase Unknown South Korea IV / Injection ImmuneMed 30 Mar 2020
Coronavirus infections - - Preclinical South Korea unspecified / unspecified ImmuneMed 30 Mar 2020
Hepatitis B - - No development reported (Preclinical) United Kingdom IV / unspecified ImmuneMed, Lonza 28 Apr 2020
Hepatitis B - - No development reported (Preclinical) South Korea IV / unspecified ImmuneMed 28 Apr 2020
Hepatitis C - - No development reported (Preclinical) South Korea IV / unspecified ImmuneMed 28 Apr 2020
Hepatitis C - - No development reported (Preclinical) United Kingdom IV / unspecified ImmuneMed, Lonza 28 Apr 2020
Herpesvirus infections - - Preclinical South Korea IV / unspecified ImmuneMed 03 Sep 2018
Influenza virus infections - - No development reported (Preclinical) South Korea IV / unspecified ImmuneMed 28 Apr 2020
Influenza virus infections - - No development reported (Preclinical) United Kingdom IV / unspecified ImmuneMed, Lonza 28 Apr 2020
Viral infections - In volunteers Phase I South Korea IV / unspecified ImmuneMed 29 Nov 2018
Viral infections encephalomyocarditis virus - No development reported (Preclinical) United Kingdom IV / unspecified ImmuneMed, Lonza 28 Apr 2020

Commercial Information

Involved Organisations

Organisation Involvement Countries
ImmuneMed Originator South-Korea
ImmuneMed Owner South-Korea
Lonza Technology Provider Switzerland

Licensing Availability

Licensing Organisation Available Indication Available Phase Region Date
ImmuneMed - Clinical Phase Unknown - 03 Sep 2018

Scientific Summary

Pharmacodynamics

The inflammatory cytokine production was inhibited after administration of VSF in experimental coronavirus-infected mice. Reduction in IFN-gamma, MCP-1, IL-6 and TNF-alpha were observed characteristically. VSF increases the natural healing power of cells to suppress viral replication and reduce excessive immune response and inflammation, thereby showing therapeutic effect [2] .

Future Events

Expected Date Event Type Description Updated
31 Oct 2018 Trial Update ImmuneMed plans a phase I trial for Infections (In volunteers) (IV) in October 2018 (NCT03653208) (700299385) 11 Dec 2018

Development History

Event Date Update Type Comment
28 Apr 2020 Phase Change - No development reported No recent reports of development identified for preclinical development in Hepatitis-B in South Korea (IV) Updated 28 Apr 2020
28 Apr 2020 Phase Change - No development reported No recent reports of development identified for preclinical development in Hepatitis-B in United Kingdom (IV) Updated 28 Apr 2020
28 Apr 2020 Phase Change - No development reported No recent reports of development identified for preclinical development in Hepatitis-C in South Korea (IV) Updated 28 Apr 2020
28 Apr 2020 Phase Change - No development reported No recent reports of development identified for preclinical development in Hepatitis-C in United Kingdom (IV) Updated 28 Apr 2020
28 Apr 2020 Phase Change - No development reported No recent reports of development identified for preclinical development in Influenza-virus-infections in South Korea (IV) Updated 28 Apr 2020
28 Apr 2020 Phase Change - No development reported No recent reports of development identified for preclinical development in Influenza-virus-infections in United Kingdom (IV) Updated 28 Apr 2020
28 Apr 2020 Phase Change - No development reported No recent reports of development identified for preclinical development in Viral-infections in United Kingdom (IV) Updated 28 Apr 2020
30 Mar 2020 Phase Change - Clinical Clinical trials in COVID-2019 infections in South Korea (IV) before March 2020 [2] Updated 02 Apr 2020
30 Mar 2020 Phase Change - Preclinical Preclinical trials in Coronavirus infections in South Korea (unspecified route) before March 2020 [2] Updated 02 Apr 2020
30 Mar 2020 Regulatory Status ImmunoMed files for the use of hzVSF v13 for use in treatment of 25 patients with COVID-2019 infections in South Korea [2] Updated 02 Apr 2020
30 Mar 2020 Scientific Update Pharmacodynamics data from a preclinical study in Coronavirus infections released by ImmunoMed [2] Updated 02 Apr 2020
30 Mar 2020 Trial Update Immunomed plans clinical trials for COVID-2019 infections in South Korea and other countries [2] Updated 02 Apr 2020
27 Mar 2020 Regulatory Status The Korean Ministry of Food and Drug Safety (MFDS) approves hzVSF v13 for compassionate use in treatment of COVID-2019 infections in South Korea [2] Updated 02 Apr 2020
29 Nov 2018 Phase Change - I Phase-I clinical trials in Viral infections (In volunteers) in South Korea (IV) (NCT03653208) Updated 11 Dec 2018
03 Sep 2018 Trial Update ImmuneMed plans a phase I trial for Infections (In volunteers) (IV) in October 2018 (NCT03653208) Updated 11 Dec 2018
03 Sep 2018 Licensing Status hzVSF v13 is available for licensing as of 03 Sep 2018. http://immunemed.co.kr/ Updated 07 Sep 2018
03 Sep 2018 Phase Change - Preclinical Preclinical trials in Herpesvirus infections in South Korea (IV) (ImmuneMed website, September 2018) Updated 07 Sep 2018
08 Dec 2011 Licensing Status ImmuneMed and Lonza agree to co-develop virus suppressing factor in UK for Hepatitis, Influenza virus infections, Viral infections [1] Updated 10 Sep 2018
08 Dec 2011 Phase Change - Preclinical Preclinical trials in Hepatitis B in United Kingdom, South Korea (IV) [1] Updated 10 Sep 2018
08 Dec 2011 Phase Change - Preclinical Preclinical trials in Hepatitis C in United Kingdom, South Korea (IV) [1] Updated 10 Sep 2018
08 Dec 2011 Phase Change - Preclinical Preclinical trials in Influenza virus infections in United Kingdom, South Korea (IV) [1] Updated 10 Sep 2018
08 Dec 2011 Phase Change - Preclinical Preclinical trials in Viral infections in United Kingdom, South Korea (IV) [1] Updated 10 Sep 2018
07 Apr 2009 Patent Information ImmuneMed has patent protection for pharmaceutical composition of an anti-viral VSF protein and a method for prevention or treatment of viral infections in USA Updated 07 Sep 2018
14 Apr 2005 Patent Information ImmuneMed has patents pending for pharmaceutical composition of an anti-viral VSF protein and a method for prevention or treatment of viral infections in USA Updated 07 Sep 2018
17 Mar 2004 Patent Information ImmuneMed has patent protection for pharmaceutical composition of an anti-viral VSF protein and a method for prevention or treatment of viral infections in South Korea Updated 07 Sep 2018
07 Aug 2003 Patent Information ImmuneMed has patents pending for pharmaceutical composition of an anti-viral VSF protein and a method for prevention or treatment of viral infections in World Updated 07 Sep 2018

References

  1. Lonza Signs Applied Protein Services Agreement with ImmuneMed for Immunogenicity Risk Assessment and Deimmunization of Novel Protein.

    Media Release
  2. ImmuneMed's 'hzVSF,' Used for Treatment of COVID-19 Pneumonia Patients.

    Media Release
  3. Dose Blocked-randomized, Double-blind, Placebo Controlled, Single Dose, Dose-escalation Study to Investigate the Safety, Tolerability, Pharmacokinetic Characteristics of hzVSF-v13 After Intravenous Administration in Healthy Male Volunteers

    ctiprofile
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