Advanced and Metastatic Breast Cancer
	Advanced and metastatic breast cancers are the most advanced stages (stage III- IV) of breast cancer and has a very poor prognosis. Cancer cells have spread past the breast and axillary lymph nodes to other areas of the body where they continue to grow and multiply. These stages of breast cancer have the potential to spread to almost any region of the body. The most common region breast cancer spreads to is the bone, followed by the lung and liver.  Advanced and metastatic breast cancers expressing HER2  (Epidermal Growth Factor Receptor 2) are found on the outer surface of 25 to 30% of breast cancer cells. Biotecnol’s novel compact antibody – CAB051 – strongly interferes with HER2-positive tumor cells, preventing their growth, and causing them to die.  CAB051 is unique in the sense that binds to a novel epitope of the HER2 receptor and has shown to have reduced cardiotoxicity as well as strong activity in anti-HER2 resistant breast tumours, treated with other commercial antibodies . Because the efficacy of cancer drugs is limited and usually at the cost of safety, while CAB501 may limit the risk of cardiotoxicity as compared to its peer drugs may open the door for patient convenience. The onset of CAB501´s  in-vivo effect seems to be observable earlier on during treatment with the product and remains sustained throughout the duration of the study. From that perspective a once per three weeks administration instead of once per week may be envisaged, which would be in schedule with the commonly used anti-cancer drug regimen, thus potentially improving patient convenience in comparison to other alternative antibody drugs. CAB051 has been extensively characterized and well-studied. Its characteristics, mechanisms of action and unique effects have been widely published in high-impact peer-reviewed journals. Such novel antibody could be a very useful alternative to existing anti-HER2 antibodies and may be of usefulness when administered in combination with upstream-downstream HER2 pathways effectors.  Due to its properties, CAB051 may be administered in patients that present cardiotoxicity symptoms during treatment with other anti-HER2 antibodies and/or anthracyclines. Likewise, on-going studies concerning strong antineoplastic response of CAB051 in cases of refraction to other anti-HER2 therapies are on-going. Results therefor suggest that CAB051 may be applicable in patients that do not respond to current anti-HER2 antibody therapies and hence refraction as well as cardiotoxicity on-set during the treatment with current anti-HER2 antibodies, are being investigated and such conditions constitute major unmet needs and a clear opportunity for Fast Track Designation.