Pipeline

Granulocyte Colony-Stimulating Factor (G-CSF) is a protein that stimulates production of neutrophils, a type of white blood cell important for fighting infections. Recombinant G-CSF is used to treat chemotherapy-induced neutropenia, promote bone marrow engraftment and mobilize hematopoietic stem cells for transplantation. Annual worldwide sales of G-CSF products are $6 billion. G-CSF is administered to patients by daily subcutaneous injection. Our long acting G-CSF analogs were created using Site-Specific PEGylation (BBT-015) and ImmunoFusion Protein (BBT-018) technologies. BBT-015 and BBT-018 can be administered less frequently and are more effective than G-CSF at accelerating recovery from chemotherapy-induced neutropenia in rodent models. BBT-015 has proven effective at increasing survival in animal models of acute radiation syndrome.

Beta interferon products are used to treat Multiple Sclerosis and have worldwide sales of about $6 billion. Multiple Sclerosis is a debilitating neurological disease that affects an estimated 400,000 people in the United States and 2.5 million people worldwide. Beta Interferon also has shown promise at treating viral diseases such as Hepatitis B and Hepatitis C, and various cancers. Most patients receive Beta Interferon products three times per week by injection. Our site-specific PEGylated Beta Interferon analog, BBT-032, has a longer circulating half-life than Beta Interferon and is significantly more effective than Beta Interferon in animal disease models such as inhibiting growth of human tumor cells in athymic mice.

Granulocyte-Macrophage Colony-Stimulating Factor (GM-CSF) is a protein that stimulates production of multiple types of white blood cells, including neutrophils and macrophages. Recombinant GM-CSF is used to treat chemotherapy-induced neutropenia, promote bone marrow engraftment and mobilize hematopoietic stem cells for transplantation. Currently marketed GM-CSF products are administered by daily injection. Our site-specific PEGylated GM-CSF analog, BBT-007, has a longer half-life than GM-CSF and is more effective than GM-CSF at stimulating production of white blood cells and accelerating recovery from neutropenia in rodent models. A murine BBT-007 homolog is very effective at preventing death from acute radiation syndrome in animals.

Gamma interferon is used to treat chronic granulomatous disease and malignant osteopetrosis. Annual worldwide sales of gamma interferon products are about $100 million. Our site-specific PEGylated gamma interferon analog, BBT-046, has an approximate 25-fold longer half-life than gamma interferon and is more effective than gamma interferon in animal disease models such as inhibiting growth of human cancer cells in athymic mice.

Interleukin-11 (IL-11) stimulates production of platelets, which are blood cells involved in the blood clotting process. IL-11 is used to reverse thrombocytopenia (low platelet counts), which is a frequent side-effect of chemotherapy treatment in cancer patients. Our site-specific PEGylated IL-11 analog, BBT-059, stimulates platelet formation for up to a week following a single injection in rodents, whereas IL-11 requires multiple, daily injections to achieve similar effects. BBT-059 also prevents ischemia-reperfusion injury and is an effective treatment for acute radiation syndrome in animals.

Erythropoietin (EPO) is a glycoprotein that stimulates production of red blood cells and is used to treat anemia resulting from chemotherapy, chronic renal failure and HIV drug complications, and to boost red blood cell levels prior to elective surgeries. Annual worldwide sales of recombinant EPO products are $16 billion. BBT-021 is a long-acting EPO ImmunoFusion Protein. BBT-009 was created using Site-Specific PEGylation technology. BBT-021 and BBT-009 have 10- fold and 6-fold longer half-lives, respectively, than EPO, and are potent than EPO at stimulating red blood cell formation in animals. A single injection of BBT-021 causes an increase in red blood cells that lasts for over 2 weeks in a rodent, whereas the same dose of EPO shows no effect.

Growth Hormone stimulates production of bone, cartilage and muscle and is the body's primary hormone for stimulating growth during childhood. Recombinant human Growth Hormone is used to treat short stature, growth hormone deficiency in children and adults and has shown promise in treating HIV-associated wasting and lipodystrophy. Current commercial Growth Hormone products are administered to patients by daily subcutaneous injection. These products have worldwide sales of about $3 billion. Our site-specific PEGylated Growth Hormone analog, BBT-031, has a 10- to 20-fold longer circulating half-life than Growth Hormone and is more effective than Growth Hormone at stimulating bone and body growth in rodent models of Growth Hormone deficiency.

Alpha interferon is used to treat viral diseases such as Hepatitis B and Hepatitis C, and cancers such as melanoma, hairy cell leukemia and Kaposi's sarcoma. Annual worldwide sales of alpha interferon products are about $1.5 billion, most of which represents sales by amine-PEGylated alpha interferon products. Our site-specific PEGylated alpha interferon product, BBT-012, is nearly 10-fold more potent than the leading commercial amine-PEGylated alpha interferon product.