Looking for a licensing partner to develop my drug candidate for herpes zoster

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Therapeutic Candidate for the Post-infection Treatment of Herpes Zoster Virus (HZV) Infection Licensing Opportunity • Clinically tested therapeutic vaccine candidate for the treatment of severe HZV infection designed to:  Reduce the duration of herpetic lesions from 3-5 weeks to a few days  Reduce shedding of infectious viral particles  Reduce pain and post-herpetic neuralgia (PHN) • Licensing package includes:  Key intellectual property  Product candidate design  Access to HepC’s proprietary industrial platform technology and manufacturing cell lines Case History Facial herpes zoster virus (HZV) infection (shingles) with edema around the eye is an emergency. When the 76-year-old author of this flyer, who is a medical doctor, felt an intermittent throbbing pain from the frontal bones to the nuchal areas of skin and the rashes and blisters expanded from the top of his head to the region around the eye with fast-increasing periorbital edema accompanied by strong yellow discharge, he diagnosed his own shingles. Because the disease started with atypical signs, conventional acyclovir (ACV) treatment was administered too late, only 96 hours after the onset of skin rash, when the window of ACV efficacy has been closed. Therefore, conventional treatment was complemented with an add-on experimental antiviral superinfection therapy. Therapeutic Candidate Highlights Superinfection targets the host rather than the virus. A harmless live attenuated bird vaccine virus (infectious bursal disease virus; IBDV) delivers its double-stranded RNA (dsRNA) genome cargo to host cells. As most viruses produce dsRNA at some point during their replication, dsRNA is a molecular danger signal of viral infection. The dsRNA of IBDV activates the natural antiviral interferon gene defense system without harming the host cells. This harmless therapeutic virus drug candidate has already been effective against five different viruses, HAV, HBV, HCV, SARS-CoV-2, and HZV. IBDV is orally administered in an outpatient setting, it is easy to manufacture and will be affordable even in resource-limited countries. The German Paul Ehrlich Institute supports a phase I safety study for patients with early COVID-19 disease. The NIH ACTIV expert team felt that IBDV strain R903/78 shows merit as a potential treatment for COVID-19. Treatment and Results The orally administered attenuated live IBDV vaccine virus (10^6 Infectious Unit [IU]/day) rapidly decreased the periorbital edema and most symptoms were resolved within four days, while the average time to crustation with ACV monotherapy is 15 days (Figure: The author's HZO with periorbital edema at the peak of disease and in recovery). This very short disease duration seems to be unusual particularly because the severe periorbital edema was an early sign of an ophthalmologic emergency that would have required hospital care. In fact, such a fast resolution of the periorbital edema and the quick crusting of vesicles cannot be explained by the ACV treatment alone. Competitive Advantage Most cases of shingles last 3-5 weeks. ACV administered even at the onset of the earliest symptoms could only modify the symptoms but is unable to change the duration of the disease. Most people get shingles only once. However, about 1 in 3 people do get shingles. Therefore, IBDV superinfection treatment could ease the suffering of many million patients with shingles. Proposal In order to confirm the data obtained in a single patient, a small Phase I/II clinical trial is proposed. Patients with clinically confirmed HZV infection, older than 60 years of age, will be assigned in a 1:1 ratio to receive either ACV monotherapy or ACV plus IBDV vaccine virus therapies for 7 days (10^6 IU/day). The primary endpoints will be the efficacy of the IBDV viral vaccine drug candidate against clinically confirmed HZV infection and safety. Efficacy will be measured by the difference between the healing period observed during mono- and combination therapy. See more in: Bakacs, T., V. Sandig and I. Kovesdi (2023). "Combination Therapy for the Treatment of Shingles with an Immunostimulatory Vaccine Virus and Acyclovir." Pharmaceuticals 16(2): 226.

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