ImmuneMed has discovered an endogenous broad-spectrum antiviral drug candidate with novel mechanisms of action. Preclinical tests suggest that the drug is effective against virus-infected cells, which has prompted the company to begin raising money to move the program into the clinic and through to phase 2.
Based in Chuncheon, South Korea, ImmuneMed aims to improve the treatment and diagnosis of infectious diseases by using its antibody and antigen discovery technologies. One of these platforms enables ImmuneMed to develop and discover antibodies with specificity for particular serotypes, species, and genera. The other technology supports the discovery of both serotype-specific and group-specific antigens.
ImmuneMed has used these capabilities to develop a pipeline of drug and diagnostic candidates. The centerpiece of its R&D operation is the antiviral candidate humanized virus suppressing factor (hzVSF). The drug 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. In animal models, hzVSF inhibits pathological activities and improves clinical symptoms.
ImmuneMed has demonstrated the potential of hzVSF in a series of preclinical tests (Fig. 1). The studies looked at the efficacy of the candidate against the encephalomyocarditis virus, influenza, and hepatitis B and C in vitro and in vivo using several different animal models. ImmuneMed also performed preclinical toxicology studies in rats and dogs.
Figure 1: The clinical potential of hzVSF. (a, b) Antiviral activity of hzVSF against the influenza virus, as measured by changes in body weight (a) and clinical score (b). (c) Examination of VSF receptor (VR) in HBVand HCV-infected human liver tissue.
Moving into the clinic
The data from these studies have encouraged ImmuneMed to prepare for a phase 1 trial in healthy volunteers. The company has already filed for clearance from the Korean Ministry of Food and Drug Safety to run a clinical trial and expects to start enrolling subjects by the end of the year. Beyond that, ImmuneMed plans to gain clearance from the US Food and Drug Administration to test the drug under its jurisdiction.
ImmuneMed is working with its partner Lonza to prepare for these studies. Lonza has applied its immunogenicity risk assessment and de-immunization capabilities to hzVSF, which has low immunogenicity comparable to that of the anti-inflammatory Humira (adalimumab).
Now, with ImmuneMed on the cusp of moving hzVSF into clinical trials, Lonza’s role in the program has expanded to cover work on chemistry, manufacturing, and controls. As one of the leading contract manufacturing organizations, Lonza is establishing the cell line and manufacturing hzVSF under pilot and good manufacturing practice (GMP) conditions.
With these building blocks in place, ImmuneMed is looking to bring other companies on board to support the advance of the program. It would like to find a collaborator with expertise in bacterial and viral diseases to help to develop diagnostics and examine the efficacy of hzVSF.
ImmuneMed is also working to raise money to fund clinical development. The company funded aspects of early hzVSF development with grants, but it is now looking for venture capital investment to support the advance of hzVSF to phase 2. Now is a good time for investors to take a stake in the firm; within the next two years, ImmuneMed expects to generate clinical data on hzVSF and list company shares in an initial public offering.
Investors could also benefit from ImmuneMed’s partnering plans. The company is content to enter clinical trials unpartnered, but the outlicensing of assets is part of its long-term strategy. Talks with several multinational pharmaceutical companies are already under way. These discussions may lead to collaboration agreements or licensing deals covering ImmuneMed’s antiviral and anti-inflammatory programs.
A broad attack on infectious diseases
As befits a firm with the goal of freeing humanity from infectious diseases, ImmuneMed’s activities extend well beyond hzVSF. Through its in-house activities and collaborations with research groups at several universities, ImmuneMed is also developing diagnostics that deliver results within 15 minutes.
The diagnostics program is developing rapid tests for dengue fever, dengue hemorrhagic fever, typhoid fever, and varicella-zoster virus, the last of which is the cause of chickenpox. The program is fairly advanced: ImmuneMed already has a manufacturing process in place for its rapid diagnostic kits and is planning to introduce a series of tests to the market over the next two years. ImmuneMed already markets rapid diagnostic kits for acute infectious diseases such as scrub typhus, leptospirosis, and hemorrhagic fever with renal syndrome.
Infections targeted by ImmuneMed’s diagnostics affect more than 10,000 people a year in Korea and many times that number around the world. Thus, the development of rapid assessments for these conditions would further ImmuneMed’s ambition to improve global health by addressing unmet needs in the infectious disease space.
ImmuneMed has held this ambition since it was founded in 2000 and, after laying the groundwork through years of in-house and collaborative research activities, it is now in a position to start realizing this goal.
As it moves into this new, exciting phase of its history, ImmuneMed is looking to team up with other organizations to aid the company in its goal. The top near-term priority is to secure investment to take hzVSF through early-phase clinical trials in South Korea and North America.
Director of Research Institute
Chuncheon, Republic of Korea