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Therapeutic Focus and Applications
R&D in Brief
RBT is developing a carbohydrate-targeted nanocarrier termed the TargoSphere®.
The TargoSphere® has been shown to encapsulate active pharmaceutical ingredients (APIs) comprising peptides, proteins, large protein adducts, nucleic acids, and small molecular compounds spanning a range of molecular weights from approx. 0.025 to 500 kDa.
This targeted drug delivery system specifically addresses C-type lectin receptors (CLRs) on myeloid APCs (immature and mature dendritic cells, tissue macrophages, and blood monocytes), liver-resident cell populations (sinusoidal endothelial cells and hepatic stellate cells), and possibly plasmacytoid dendritic cells.
RBT has inlicensed from the NIH a virucidal lectin that highly potently bind to, agglutinate and inactivate all RNA and DNA viruses tested thus far. This lectin - termed RBT05 in RBT’s development pipeline - does not act mitogenic, mutagenic, carcinogenic or immunogenic. When delivered via the TargoSphere®, RBT05 is able to agglutinate viruses harbored within reservoir cells so that in-trans infection from such cells is completely abrogated. We believe that it will be imperative to complement current gold-standard therapies for HCV and HIV with this treatment so as to close the current therapeutic gaps that impede to heal these diseases.
In a seven-day linear dose-escalation study in the Lewis (LEW) rat model, neither mock-loaded TargoSpheres® nor TargoSpheres® with encapsulated RBT05 or free RBT05 caused any systemic or organ-specific toxicity.
In the same animal model, we have also seen preliminary evidence for successful crossing of the blood-brain barrier with subsequent targeting of activated microglia and astrocytes that are known to express CLRs.
Some Key Advantages in Brief
The TargoSphere®
By specifically binding to CLRs, the TargoSphere® harnesses an ancient family of receptors that has remained highly conserved throughout evolution. This receptor system for binding and uptake of pathogens serves as one of the most stable pillars of the innate and adaptive branches of immunity alike. This guarantees a steadfast mode of therapy that may enter cells expressing such CLRs even in late stages of disease.
USP of the TargoSphere® when compared to conventional treatments:
General Advantages
• Target cell specificity
• No treatment resistance due to the lack of CLR mutation
• Great variance of therapeutic payloads
• Inexpensive as opposed to antibody- or ligand-dependent targeting
Specific Advantages
• Increased effective dose forms
• Increased therapeutic index
• Reduced treatment cycles
• Greater patient compliance
• Improved cost/benefit ratio
• Increased quality of life for the patient
The Payload RBT05
When being delivered via the TargoSphere® into viral reservoir cells, the virus-specific lectin RBT05 agglutinates intracellular virions by binding to their envelope’s largely immutable carbohydrate decoration. RBT05 thus hits viruses such as HCV and HIV at their true ‘Achilles heel’ as they cannot evade this treatment in contrast to current gold standard therapies that solely focus on the replication or transcription/translation of the viral genomes.
Development Pipeline in Brief
RBT’s development pipeline currently comprises
• TargoSphere®-delivered treatments for eradicating cellular viral reservoirs in
• HCV/Hepatitis C and HIV/AIDS as well as
• TargoSphere®-dependent vaccination approaches for various cancers as well as malaria,
• in which novel cancer and malaria protein vaccines are administered.
• Furthermore, RBT has successfully completed a pilot study in the area of specific immuno-
• therapy for treating allergic diseases.
Further Information
HCV / Hepatitis C
In the industrial and developing world, an estimated 200 million people are infected with HCV, the most common global viral infection. In most instances, acute Hepatitis C infection evolves into a chronic viral disease with devastating short-term and long-term disabilities and a high mortality rate. Its serious sequelae include liver cirrhosis, acute-on-chronic liver failure, and hepatocellular carcinoma.
HCV typically infects hepatocytes. However, it also enters APCs and other liver-resident cell populations that are exploited by the virus as cellular reservoirs. Importantly, these reservoir cells carry receptors on their surface that serve as the TargoSpheres® sites for recognition and uptake. RBT05-loaded TargoSpheres® may thus be employed to address both cells in which this virus actively propagates as well as cells that serve as long-term reservoir sites. Rodos BioTarget has conceived of this approach as an important addition to state-of-the-art treatments.
Further Reading
Szabo E, Lotz G, Paska C, Kiss A, Schaff Z. Viral Hepatitis: new data on hepatitis C infection. Pathol Oncol Res 2003;9:215-21.
HIV / AIDS
According to the UNAIDS 2008 Report on HIV/AIDS epidemic, around 30.8 million adults and 2 million children were living with HIV at the end of 2007. Also in 2007, around 2.7 million people were newly infected with HIV. This figure includes 370,000 children aged 14 or younger. By the end of 2007, the epidemic had left behind 15 million orphans under 18 years of age who lost one or both parents to AIDS.
HIV typically infects CD4+ T-helper cells. However, it is also known to reside in reservoirs of APCs from where providing continuous infection to the T-helper cells in which HIV actively replicates and spreads to numerous other immune cells, thus causing vigorous HIV propagation, cellular destruction and, eventually, generalized immunodeficiency leading to AIDS. A TargoSphere®/RBT05-mediated approach highly similar to that described for treating HCV/Hepatitis C thus again offers true hope for completely eradicating reservoirs of HIV from many patients, and even to offer relief for patients from whom the viral reservoir may be only partly eliminated.
Further Reading
Steinbrook R. The AIDS Epidemic in 2004. N Engl J Med 2004;351:115-7.
RBT is developing a carbohydrate-targeted nanocarrier termed the TargoSphere®.
The TargoSphere® has been shown to encapsulate active pharmaceutical ingredients (APIs) comprising peptides, proteins, large protein adducts, nucleic acids, and small molecular compounds spanning a range of molecular weights from approx. 0.025 to 500 kDa.
This targeted drug delivery system specifically addresses C-type lectin receptors (CLRs) on myeloid APCs (immature and mature dendritic cells, tissue macrophages, and blood monocytes), liver-resident cell populations (sinusoidal endothelial cells and hepatic stellate cells), and possibly plasmacytoid dendritic cells.
RBT has inlicensed from the NIH a virucidal lectin that highly potently bind to, agglutinate and inactivate all RNA and DNA viruses tested thus far. This lectin - termed RBT05 in RBT’s development pipeline - does not act mitogenic, mutagenic, carcinogenic or immunogenic. When delivered via the TargoSphere®, RBT05 is able to agglutinate viruses harbored within reservoir cells so that in-trans infection from such cells is completely abrogated. We believe that it will be imperative to complement current gold-standard therapies for HCV and HIV with this treatment so as to close the current therapeutic gaps that impede to heal these diseases.
In a seven-day linear dose-escalation study in the Lewis (LEW) rat model, neither mock-loaded TargoSpheres® nor TargoSpheres® with encapsulated RBT05 or free RBT05 caused any systemic or organ-specific toxicity.
In the same animal model, we have also seen preliminary evidence for successful crossing of the blood-brain barrier with subsequent targeting of activated microglia and astrocytes that are known to express CLRs.
Some Key Advantages in Brief
The TargoSphere®
By specifically binding to CLRs, the TargoSphere® harnesses an ancient family of receptors that has remained highly conserved throughout evolution. This receptor system for binding and uptake of pathogens serves as one of the most stable pillars of the innate and adaptive branches of immunity alike. This guarantees a steadfast mode of therapy that may enter cells expressing such CLRs even in late stages of disease.
USP of the TargoSphere® when compared to conventional treatments:
General Advantages
• Target cell specificity
• No treatment resistance due to the lack of CLR mutation
• Great variance of therapeutic payloads
• Inexpensive as opposed to antibody- or ligand-dependent targeting
Specific Advantages
• Increased effective dose forms
• Increased therapeutic index
• Reduced treatment cycles
• Greater patient compliance
• Improved cost/benefit ratio
• Increased quality of life for the patient
The Payload RBT05
When being delivered via the TargoSphere® into viral reservoir cells, the virus-specific lectin RBT05 agglutinates intracellular virions by binding to their envelope’s largely immutable carbohydrate decoration. RBT05 thus hits viruses such as HCV and HIV at their true ‘Achilles heel’ as they cannot evade this treatment in contrast to current gold standard therapies that solely focus on the replication or transcription/translation of the viral genomes.
Development Pipeline in Brief
RBT’s development pipeline currently comprises
• TargoSphere®-delivered treatments for eradicating cellular viral reservoirs in
• HCV/Hepatitis C and HIV/AIDS as well as
• TargoSphere®-dependent vaccination approaches for various cancers as well as malaria,
• in which novel cancer and malaria protein vaccines are administered.
• Furthermore, RBT has successfully completed a pilot study in the area of specific immuno-
• therapy for treating allergic diseases.
Further Information
HCV / Hepatitis C
In the industrial and developing world, an estimated 200 million people are infected with HCV, the most common global viral infection. In most instances, acute Hepatitis C infection evolves into a chronic viral disease with devastating short-term and long-term disabilities and a high mortality rate. Its serious sequelae include liver cirrhosis, acute-on-chronic liver failure, and hepatocellular carcinoma.
HCV typically infects hepatocytes. However, it also enters APCs and other liver-resident cell populations that are exploited by the virus as cellular reservoirs. Importantly, these reservoir cells carry receptors on their surface that serve as the TargoSpheres® sites for recognition and uptake. RBT05-loaded TargoSpheres® may thus be employed to address both cells in which this virus actively propagates as well as cells that serve as long-term reservoir sites. Rodos BioTarget has conceived of this approach as an important addition to state-of-the-art treatments.
Further Reading
Szabo E, Lotz G, Paska C, Kiss A, Schaff Z. Viral Hepatitis: new data on hepatitis C infection. Pathol Oncol Res 2003;9:215-21.
HIV / AIDS
According to the UNAIDS 2008 Report on HIV/AIDS epidemic, around 30.8 million adults and 2 million children were living with HIV at the end of 2007. Also in 2007, around 2.7 million people were newly infected with HIV. This figure includes 370,000 children aged 14 or younger. By the end of 2007, the epidemic had left behind 15 million orphans under 18 years of age who lost one or both parents to AIDS.
HIV typically infects CD4+ T-helper cells. However, it is also known to reside in reservoirs of APCs from where providing continuous infection to the T-helper cells in which HIV actively replicates and spreads to numerous other immune cells, thus causing vigorous HIV propagation, cellular destruction and, eventually, generalized immunodeficiency leading to AIDS. A TargoSphere®/RBT05-mediated approach highly similar to that described for treating HCV/Hepatitis C thus again offers true hope for completely eradicating reservoirs of HIV from many patients, and even to offer relief for patients from whom the viral reservoir may be only partly eliminated.
Further Reading
Steinbrook R. The AIDS Epidemic in 2004. N Engl J Med 2004;351:115-7.
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