The medical need in metastatic colorectal cancer (mCRC) is significant, as it is a complex and aggressive disease with limited treatment options. Some of the key medical needs include:
Trifluridine (FTD) is a nucleoside analog used for the treatment of keratitis and keratoconjunctivitis caused by the herpes simplex virus types 1 and 2, as well as for prevention and treatment of vaccinia virus infections of the eye. Trifluridine is also approved for oral administration in combination with tipiracil for the treatment of adult patients with mCRC It. Trifluridine is incorporated into DNA, leading to DNA damage and apoptosis (cell death) in cancer cells. Its efficacy in mCRC is limited and the product is associated with side effects like myelosuppression, fatigue, nausea, diarrhea, and pyrexia. 165Bio is developing Bio-001 an IV formulation of FTD with unique dosing and combination with other drugs to allow for better targeting and an improved therapeutic window of FTD.
165Bio is in late pre-clinical stage studies, planning to initiate early-stage Phase I/II clinical studies in the near future targeting patients with metastatic colorectal cancer.