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Atossa Genetics (ATOS) Announces CAR-T Program in Breast Cancer

By Grant Zeng, CFA


On October 2, Atossa Genetics (NASDAQ:ATOS) announced a new program using Chimeric Antigen Receptor Therapy (CAR-T). The company plans to use its proprietary intraductal microcatheter technology to deliver CAR-T cells into the ducts of the breast for the potential targeted treatment of breast cancer.

Chimeric antigen receptors (CAR-T) are engineered receptors, which graft an arbitrary specificity onto an immune effector cell (T cell). Typically, these receptors are used to graft the specificity of a monoclonal antibody onto a T cell, with transfer of their coding sequence facilitated by retroviral vectors. The receptors are called chimeric because they are composed of parts from different sources.

CAR-T technology has been the subject of much attention recently. 

In late August, Novartis receives first ever FDA approval for a CAR-T cell therapy, Kymriah(TM) (CTL019), for children and young adults with B-cell ALL that is refractory or has relapsed at least twice. 

Also in early October, Gilead Sciences (GILD) closed the acquisition of Kite Pharma (KITE) for $180 per share at approximately $11.9 billion in the aggregate. KITE is focused on CAR-T therapy for cancers and its lead candidate axicabtagene ciloleucel (also known as KTE-C19) is under the FDA review and is expected to get the FDA approval in November. 

In clinical studies, CAR-T therapy has shown strong efficacy and tolerable safety profile. 

Atossa is going to uses its proprietary intraductal microcatheter technology for the potential transpapillary, or “TRAP,” delivery of T-cells that have been genetically modified to attack breast cancer cells. Specifically, T cells are removed from a patient and modified so that they express receptors specific to the patient's particular breast cancer. The T cells, which can then recognize and kill the cancer cells, are reintroduced into the patient using a microcatheter into the natural ducts of the breast. Clinical trials have demonstrated “that cytotoxic drugs can be safely administered into breast ducts with minimal toxicity using the transpapillary (TRAP) delivery of therapeutics in breast cancer. 

The company believes this method has several potential advantages: 

• reduced toxicity by limiting systemic exposure of the T-cells; 
• improved efficacy by placing the T-cells in direct contact with the target ductal epithelial cells that are undergoing malignant transformation; 
• and, lymphatic migration of the CAR-T cells along the same path taken by migrating cancer cells, potentially extending their cytotoxic actions into the regional lymph system, which could limit tumor cell dissemination. 

Atossa’s unique approach is in the research and development phase. But we believe the company’s proprietary TRAP technology could provide a potentially safer yet effective method to deliver CAR-T. 

Now that the company has developed a foundational intellectual property position with respect to TRAP CAR-T, the company intends to continue research and development through partnership with leading investigators, institutions, and organizations around the world, bringing Atossa’s technology and expertise in TRAP delivery together with experts in cancer immunology and T-cell biology. 

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