SBIR-STTR Award

Mortality rates associated with Marburg virus (MARV) outbreaks range from 23% to over 90%. MARV is included by the Centers for Disease Control and Prevention as among the Category A agents, or "high-priority agents ... that pose a risk to national security." MARV not only causes acute and terrifying disease with high mortality rates, but it is relatively stable in wet or dry aerosols; it is highly infectious (LD50 is approximately 1 plaque-forming unit, or PFU) whether infection occurs parenterally or by aerosol; it can be grown to exceedingly high titers in cell cultures or animals; it is subject to nosocomial and iatrogenic spread to and by health care personnel; and as an endemic African virus it could be acquired from recurrent natural outbreaks by a resourceful individual or group. There are currently no drugs available for preventing or treating infections with MARV. There is a clear unmet need for a MARV immunoprotectant to address biowarfare as well as public health concerns raised by regular naturally occurring outbreaks. Passive immunization with antibodies has been shown to be effective against a wide variety of viral, bacterial, fungal, and parasitic diseases that affect humans. The Product Development Goals of this proposal - a collaboration between Mapp Biopharmaceutical and the U.S. Army Medical Research Institute of Infectious Diseases - are to: (1) generate a panel of fully human anti-MARV Mabs; (2) select lead anti-MARV Mabs based upon efficacy in mouse models; and (3) compare the protective efficacy of the lead Mabs when expressed in mammalian cell culture with the identical Mabs expressed in a rapid, low-cost, highly scalable manufacturing system. In addition to the cost savings, this system offers a rapid response manufacturing capability that can be used to address other biodefense and emerging and re-emerging infectious disease pathogens. The Long Range Objective of this project is to develop a safe and effective immunoprotectant product for MARV.

Public Health Relevance:
The efforts in this proposal will help in the development of a drug for preventing and/or treating Marburg virus, a potential biowarfare agent, for which no treatment currently exists.

Public Health Relevance:
Relevance The efforts in this proposal will help in the development of a drug for preventing and/or treating Marburg virus, a potential biowarfare agent, for which no treatment currently exists.

Thesaurus Terms:
There Are No Thesaurus Terms On File For This Project.

Mortality rates associated with Marburg virus (MARV) outbreaks range from 23% to over 90%. MARV is included by the Centers for Disease Control and Prevention as among the Category A agents, or "high-priority agents ... that pose a risk to national security." MARV not only causes acute and terrifying disease with high mortality rates, but it is relatively stable in wet or dry aerosols; it is highly infectious (LD50 is approximately 1 plaque-forming unit, or PFU) whether infection occurs parenterally or by aerosol; it can be grown to exceedingly high titers in cell cultures or animals; it is subject to nosocomial and iatrogenic spread to and by health care personnel; and as an endemic African virus it could be acquired from recurrent natural outbreaks by a resourceful individual or group. There are currently no drugs available for preventing or treating infections with MARV. There is a clear unmet need for a MARV immunoprotectant to address biowarfare as well as public health concerns raised by regular naturally occurring outbreaks. Passive immunization with antibodies has been shown to be effective against a wide variety of viral, bacterial, fungal, and parasitic diseases that affect humans. The Product Development Goals of this proposal - a collaboration between Mapp Biopharmaceutical and the U.S. Army Medical Research Institute of Infectious Diseases - are to: (1) generate a panel of fully human anti-MARV Mabs; (2) select lead anti-MARV Mabs based upon efficacy in mouse models; and (3) compare the protective efficacy of the lead Mabs when expressed in mammalian cell culture with the identical Mabs expressed in a rapid, low-cost, highly scalable manufacturing system. In addition to the cost savings, this system offers a rapid response manufacturing capability that can be used to address other biodefense and emerging and re-emerging infectious disease pathogens. The Long Range Objective of this project is to develop a safe and effective immunoprotectant product for MARV.

Public Health Relevance:
The efforts in this proposal will help in the development of a drug for preventing and/or treating Marburg virus, a potential biowarfare agent, for which no treatment currently exists.

Thesaurus Terms:
Atgn; Acute; Address; Aerosols; Affect; African; Amino Acid Sequence; Animals; Antibodies; Antigens; Biologic Products; Biologic Warfare; Biological Agent; Biological Products; Biological Warfare; Cdc; Categories; Cell Culture Techniques; Centers For Disease Control; Centers For Disease Control (U.S.); Centers For Disease Control And Prevention; Centers For Disease Control And Prevention (U.S.); Collaborations; Communicable Diseases; Communicable Diseases, Emerging; Cost Savings; Cyclic Gmp; Development; Disease; Disease Outbreaks; Disorder; Drug Formulations; Drugs; Emerging Communicable Diseases; Evaluation; Formulation; Formulations, Drug; Frankfurt-Marburg Syndrome Virus; Future; Genes; Goals; Guanosine Cyclic 3',5'-Monophosphate; Guanosine Cyclic Monophosphate; Guanosine, Cyclic 3',5'-(Hydrogen Phosphate); Harvest; Health Care Providers; Health Personnel; Healthcare Providers; Healthcare Worker; Human; Human, General; Immune Globulins; Immunoglobulins; Immunoglobulins / Antibodies; In Vitro; Individual; Infection; Infectious Disease Pathway; Infectious Diseases; Infectious Diseases And Manifestations; Infectious Diseases, Emerging; Infectious Disorder; Injectable; Ld-50; Ld50; Lead; Lethal Dose 50; Mammalian Cell; Man (Taxonomy); Man, Modern; Marburg Virus; Medical Research; Medication; Modeling; Mortality; Mortality Vital Statistics; National Security; Nicotiana; Outbreaks; Parasitic Diseases; Passive Immunization; Pb Element; Performance; Pharmaceutic Preparations; Pharmaceutical Preparations; Pharmacology And Toxicology; Phase; Plants; Plants, General; Protein Structure, Primary; Public Health; Recurrence; Recurrent; Research Institute; Risk; Safety; Saving, Cost; Splenocyte; System; System, Loinc Axis 4; Transgenic Mice; United States Centers For Disease Control; United States Centers For Disease Control And Prevention; Viral; Virus; Viruses, General; Base; Biodefense; Biopharmaceutical; Biotherapeutic Agent; Biowarfare; Cgmp; Comparative Efficacy; Cost; Disease/Disorder; Drug/Agent; Expression Vector; Guanosine 3'5' Monophosphate; Health Care Personnel; Health Care Worker; Health Provider; Healthcare Personnel; Heavy Metal Pb; Heavy Metal Lead; Immunogen; In Vitro Testing; In Vivo; Innovate; Innovation; Innovative; Medical Personnel; Mouse Model; Non-Human Primate; Nonhuman Primate; Novel; Pathogen; Prevent; Preventing; Product Development; Protective Efficacy; Protein Sequence; Public Health Medicine (Field); Public Health Relevance; Response; Treatment Provider