Adaptimmune wins 'breakthrough' tag
Adaptimmune Therapeutics, a biopharmaceutical company with U.S. operations in Philadelphia, said Tuesday that the Food and Drug Administration has granted "breakthrough therapy designation" for its TCR engineered T-cell therapy to treat cancer.
Adaptimmune Therapeutics, a biopharmaceutical company with U.S. operations in Philadelphia, said Tuesday that the Food and Drug Administration has granted "breakthrough therapy designation" for its TCR engineered T-cell therapy to treat cancer.
The company said the designation, intended to expedite the development and review of drugs for serious or life-threatening conditions, is based on results of a Phase 1/2 trial in patients with metastatic or recurrent synovial sarcoma who received prior chemotherapy. Synovial sarcoma is a cancer of the connective tissue around joints.
Sixty percent of the 10 patients receiving the target dose of cells responded, and there was a 50 percent overall response rate in 12 patients receiving any dose of cells, the company said.
Studies are also in progress with the T-cell therapy to treat myeloma, melanoma, ovarian cancer, and non-small cell lung cancer, the most prevalent type of lung cancer.
Established in 2008, Adaptimmune aims to utilize the body's own machinery - the T-cell - to target and destroy cancer cells by using engineered T-cell receptors (TCRs) as a means of strengthening natural patient T-cell responses, the company said.
Adaptimmune, which has a collaboration and licensing agreement with GlaxoSmithKline to expedite development and commercialization of the treatment, is building a 47,400-square-foot facility at the Navy Yard in South Philadelphia, which is expected to be completed in late 2016, to accommodate a manufacturing plant and its U.S. headquarters.
Adaptimmune, which has more than 200 employees, is based in Oxford, England.
"We are pleased that the FDA has granted breakthrough therapy designation for our T-cell therapy in synovial sarcoma, recognizing both the unmet need for patients suffering from this disease as well as the promise of these early data," said Rafael Amado, Adaptimmune's chief medical officer. "We look forward to working closely with the FDA to expedite the clinical development of this therapeutic candidate."
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About the Designation
A breakthrough therapy is a drug:
Intended alone or in combination with one or more other drugs to treat a serious or life-threatening disease or condition and
Preliminary clinical evidence indicates that the drug may demonstrate substantial improvement over existing therapies on one or more clinically significant end points, such as substantial treatment effects observed early in clinical development.
Procedure: All requests for breakthrough therapy designation will be reviewed within 60 days of receipt, and the FDA will either grant or deny the request.
Once a drug is designated as breakthrough therapy, the FDA will expedite the development and review of that drug.
SOURCE: FDA EndText