2425 55th Street, Suite 210 Boulder, CO 80301 303-420-4420

Pipeline

Bolder BioTechnology has a diversified pipeline of proprietary, long-acting human protein pharmaceuticals that include potential treatments for hematological and endocrine disorders, cancer and infectious disease. These products target markets with over $20 billion in annual sales and have clearly defined clinical development paths, which will allow them to be developed cost-effectively. We believe the more convenient dosing schedules, superior efficacy and improved safety of our products will make them attractive to patients and allow our products to capture a significant portion of these lucrative markets. Our most advanced research programs are described below.

 

Clinical Indication Program Research Preclinical Phase 1 Phase 2 Phase 3

Neutropenia / ARS

BBT-015

 
 
 
 
 

Granulocyte Colony-Stimulating Factor (G-CSF) stimulates production of neutrophils, a type of white blood cell important for fighting bacterial infections. Recombinant G-CSF products have annual sales of about $6 billion, primarily for use of the proteins to treat chemotherapy-induced neutropenia (low numbers of neutrophils) in cancer patients, which increases the patient’s risk of developing severe bacterial infections and requiring expensive hospitalization. BBT-015 is a long acting, site-specific PEGylated G-CSF analog that stimulates faster neutrophil recovery than other G-CSF products in an animal model of chemotherapy-induced neutropenia, and significantly improves survival in animal models of acute radiation syndrome. We initiated testing of BBT-015 in human clinical trials in July 2017.

 

Learn More

Multiple Sclerosis

BBT-032

 
 
 
 
 

Multiple Sclerosis is a chronic central nervous system disease that affects an estimated 400,000 people in the United States and 2.5 million people worldwide. Beta interferon products are commonly used to treat Multiple Sclerosis and have annual sales of about $6 billion. Most patients treated with beta interferon products administer the drug three times per week by injection. BBT-032, our lead long-acting beta interferon analog, is expected to require only once per week to once per month administration. BBT-032 has completed preclinical testing and is anticipated to enter human clinical trials in 2018.

 

Learn More

Cancer / Alzheimer's Disease / ARS

BBT-007

 
 
 
 
 

White blood cells are critical for fighting infections, stimulating the immune system to attack cancer cells, and clearing plaque from aged brains. Granulocyte-Macrophage Colony-Stimulating Factor (GM-CSF) stimulates production of multiple types of white blood cells, including neutrophils, macrophages, dendritic cells, and microglia. Currently marketed GM-CSF products are administered by daily injection. Our long-acting GM-CSF analog, BBT-007, can be administered less frequently and with greater efficacy than GM-CSF in animal disease models.

 

Learn More

Fungal Infections

BBT-046

 
 
 
 
 

Fungal infections can be life threatening, particularly in immune compromised patients. Gamma interferon activates immune cells to fight fungal infections and directly inhibits growth of certain types of cancer cells. Gamma interferon products are used to treat chronic granulomatous disease and malignant osteopetrosis, generating annual sales of about $100 million. BBT-046, our long-acting, site-specific PEGylated gamma interferon analog, has proven significantly more effective than gamma interferon in animal disease models such as inhibiting growth of human cancer cells in athymic mice.

 

Learn More

Bleeding Disorders / ARS

BBT-059

 
 
 
 
 

Platelets are blood cells responsible for proper blood clotting. Interleukin-11 (IL-11) stimulates production of platelets and is used to reverse thrombocytopenia (low platelet counts) in cancer patients receiving chemotherapy. BBT-059, a long-acting site-specific PEGylated IL-11 analog, stimulates platelet formation for up to a week following a single injection, 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.

 

Learn More

Anemia

BBT-021

 
 
 
 
 

Anemia (low numbers of red blood cells) is a serious complication of chronic renal failure and use of certain drugs such as chemotherapy in cancer patients. Erythropoietin (EPO) stimulates production of red blood cells, and recombinant EPO products have annual sales of about $6 billion, primarily for treating anemia. BBT-021 is a long-acting EPO ImmunoFusion Protein that is significantly more potent than EPO at stimulating red blood cell formation in animals.

 

Learn More

Growth Hormone Deficiency

BBT-031

 
 
 
 
 

Growth Hormone is the body's primary hormone for stimulating growth during childhood. Recombinant human Growth Hormone is used to treat short stature in children, and growth hormone deficiency in children and adults. Current Growth Hormone products are administered by daily injection and have annual sales of about $3 billion. BBT-031 is a long-acting Growth Hormone analog that can be administered less frequently, but with comparable efficacy as daily Growth Hormone in rodent models of Growth Hormone deficiency.

 

Learn More

Viral Diseases / Cancer

BBT-012

 
 
 
 
 

Alpha interferon is one of the body’s main defense molecules for fighting viral diseases and stopping growth of cancer cells. Annual worldwide sales of alpha interferon products are about $1.5 billion. Current alpha interferon products are heterogeneous product mixtures with low and variable biological activities. Our site-specific PEGylated alpha interferon product, BBT-012, has a homogeneous structure and is nearly 10-fold more potent than the leading commercial alpha interferon product.

 

Learn More