Hepatitis B

Hepatitis
Humabs is developing an immunotherapy that potentially could provide a functional cure for chronic HBV infection, a disease affecting millions worldwide that, if left untreated, puts people at high risk of death from cirrhosis of the liver and liver cancer.
Hepatitis B is a potentially life-threatening liver infection caused by the hepatitis B virus (HBV). According to the World Health Organization (WHO), an estimated 240 million people are chronically infected with hepatitis B, and more than 600,000 people die every year due to complications from hepatitis B, including cirrhosis and liver cancer.
Current treatments for chronic disease include combinations of PEG interferon with nucleoside analogs (NUCs), such as tenofovir, entecavir or lamivudine. The HBV surface s-antigen (HBsAg) is believed to have a role in suppressing the immune response to the pathogen and is used as a clinical measure of functional cure from chronic HBV infection. Of note, NUCs have little or no effect on the reduction of HBsAg. Thus, there remains a major need for treatments that can cure patients.
Humabs’ preclinical development antibody candidate – HBC34 – is highly potent, recognizes all ten HBV genotypes and neutralizes HBV at low concentrations in vitro.
This antibody has also demonstrated in vivo, in a chronic disease model, several logs reduction near to or below the level of detection of HBsAg. In an animal model of acute HBV infection, the virus spread was completely blocked after treatment with HBC34. Based on the data to date, the Company believes that HBC34 can act in vivo through multiple mechanisms of action, including: 1) inhibition of virus entry into the host cells, thereby blocking intrahepatic HBV spread; 2) clearance of circulating HBV and HBsAg and 3) possibly the restoration of anti-HBV T cell responses.

RSV/MPV

RSV
Humabs’ product candidate has the potential to (uniquely) address RSV and MPV infections simultaneously, safely and with long-lasting effect.
Each year during a four- to six-months season, Respiratory Syncytial Virus (RSV) and Metapneumovirus (MPV) cause a large number of respiratory tract infections.
Premature infants, the elderly and patients who are immunocompromised, such as those undergoing bone marrow transplantation, are particularly susceptible to severe infection from these viruses. By the age of one year, approximately 60% of newborns globally become infected with RSV, with 2-3% of cases requiring hospitalization. Additionally, 60,000 people undergo bone marrow transplantation annually to treat leukemia and lymphoma. Prior to transplantation, they receive myeloablation therapy, which makes them highly susceptible to RSV and MPV infections.
Currently, there is a monoclonal antibody on the market - Synagis® (palivizumab) that is used to prevent RSV infection in preterm newborns. This antibody is given once a month over the course of the ~5 months-long season and has been able to cut the number of hospitalizations due to RSV infection by 50%. This antibody has not been used to treat at-risk adults, however. Given that the required dose would need to be fifteen times higher than that for newborns, there is a need for a more potent and cost-effective treatment. In addition, Synagis is ineffective against MPV.
Humabs believes it has the only immunotherapy – MPE8 – in development to simultaneously treat RSV and MPV. The Company’s preclinical development candidate has shown similarly high affinity and potency against each of these viruses and targets a highly-conserved epitope on the fusion protein of RSV and MPV, thereby reducing the risk of viral escape mutants. MPE8 has been shown to be ten times more potent in vitro than Synagis and 3-5 times more potent in vivo. Additionally, MPE8 exhibits in primate models exceptionally long serum half-life, which indicates that potentially only two injections, rather than the 5 normally required for the currently marketed product, might be needed to cover a season. These features clearly differentiate the Humabs product candidate from Synagis, as well as other products in development. Data on MPE8 have been published in the scientific journal, Nature.

Zika Virus

RSV
Humabs has discovered and optimized a highly potent antibody to develop to neutralize the Zika virus, which has become a growing global health issue.
The Zika virus belongs to the class of viruses called flaviviruses, which also includes the Dengue and West Nile viruses. The Zika virus is spread by mosquitoes and has reached large parts of the tropical and subtropical regions of the world, including parts of the United States.
The World Health Organization (WHO) declared in early 2016 a state of Public Health Emergency of International Concern (PHEIC) and predicted that 3-4 million people would become infected annually, 1.5 million of these in Brazil alone. While the symptoms of Zika infection can be absent or generally mild, the virus appears to invade the neural tissue of the fetus, leading in up to 13% of cases to microcephaly and other neural defects in offspring. The virus can also be spread by bodily fluids, including semen, and can therefore also be sexually transmitted. When patients have had prior exposure to another flavivirus, such as Dengue virus, they could be exposed to a risk of a disease enhancement effect, which may lead to much more serious disease symptoms
While attempts have been made to reduce the spread of the virus by spraying with insecticides, there are currently no vaccines or treatments against Zika, and the WHO has declared a need for a long-term approach to combatting this infection. Thus, there is an urgent need to develop therapies to treat this rapidly spreading disease.
Humabs has discovered a highly potent antibody – ZKA190 – which neutralizes Zika virus in vitro in the ng/ml range and that prevents lethal disease in animals when given at doses as low as 0.2 mg/kg. ZKA190 was engineered to prevent a potential disease enhancement effect and to potentially block or reduce the transfer through the placenta. Data pertaining to this antibody have been published in the journal, Science.