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Signal transducer and activator of transcription 3 (STAT3) is a transcription factor commonly overexpressed in many cancer types and chronic inflammatory conditions. In cancer, high levels of STAT3 increase the number of cancer cells and make them more resistant to anticancer drugs. STAT3 is also involved in the IL-6/JAK signaling pathway which has a critical inflammatory response role. Although STAT3 is a well validated cancer drug target, no effective drugs against this target have been developed. In response to this unmet need, BB1001 will first target relevant STAT3 cancers, including head and neck squamous cell carcinoma (HNSCC), non-small cell lung cancer (NSCLC), and colorectal cancer (CRC), among others. In addition, Bluedot Bio is planning to target non-cancer indications such as STAT3 genetic disorders and several inflammatory conditions.
Head and neck squamous cell carcinoma (HNSCC) is a cancer of the mucous membranes of the mouth, nose, and throat. HNSCC has an estimated incidence of 60,000 in the United States.
Non-small cell lung cancer (NSCLC) is cancer of the cells lining the surface of the lung airways, including the bronchi, bronchioles, and alveoli. NSCLC is the most common type of lung cancer, with an estimated incidence of 230,000 cases in the United States.
Colorectal cancer (CRC) is a cancer of the colon or rectum originating from the epithelial cells lining the colon or rectum. CRC cases have an incidence is estimated at 143,000 in the United States.
STAT3 gain-of-function disease (STAT3 GOF disease) and Noonan syndrome are rare, autosomal dominant genetic disorders of the immune system. Clinically, STAT3 GOF and Noonan syndrome presentation and severity vary. STAT3 GOF is characterized by a buildup of immune cells called lymphocytes and early-onset autoimmunity affecting multiple organs and tissues. Noonan syndrome is caused by the constant activation of proteins that prevents normal development in various parts of the body. BB1001 has the potential to decrease the expression of dysregulated STAT3 and therefore halt the progression of these early-onset genetic disorders.
Persistent activation of STAT3 increases chronic inflammation and contributes to diseases such as psoriasis and fibrosis. Psoriasis is a skin disease that causes red, itchy scaly patches, most commonly on the knees, elbows, trunk, and scalp. Psoriasis is a common, long-term (chronic) disease with no cure. Fibrosis is the development of fibrous connective tissue in response to an injury. This affected tissue hardens or scars making it difficult to function properly. Fibrosis occurs in many body parts but is most prevalent in the liver, lung, and heart. Fibrosis treatment is available, but no cure exists. BB1001’s ability to decrease STAT3 makes it an attractive treatment option to reduce inflammation in these two conditions.
c-Myc is one of the “super-transcription factors” that regulates the transcription of at least 15% of the entire genome. Its involvement in several pathways results in c-Myc induction of multiple functions including but not limited to metabolism, protein synthesis, cellular proliferation, and stem cell self-renewal. c-Myc is overexpressed in most human cancers and is critical in at least 40% of all solid tumors. Because of its high prevalence of deregulation and its causal role in cancer formation, maintenance and progression, targeting MYC is an attractive opportunity for Bluedot Bio’s decoy technology.
NF-ĸB is a central mediator of immune and inflammatory responses, which allows organisms to respond effectively to environmental changes. When NF-ĸB is overexpressed, it triggers an inflammatory response that promotes tumor growth. Elevated activity of NF-ĸB has been documented in various tumor tissues and inflammatory conditions. BB-3001 has the potential to address the high unmet need in NF-ĸB related diseases.