Kite has announced initial positive results from its Phase 1 study of T cell receptor (TCR) cell therapy in patients with human papillomavirus type 16 (HPV-16) positive solid tumors.
Early data of the Phase 1 study conducted by the National Cancer Institute (NCI) was presented at the American Society of Clinical Oncology (ASCO) Annual Meeting in Chicago.
Kite’s TCR therapy (KITE-439) is designed to target HPV-16, a viral strain associated with several solid tumors including cervical cancers and many head and neck cancers. This personalized immunotherapy thus activates the immune system’s ability to recognize and target specifically the tumor cells.
In the ongoing trial, 8 patients with metastatic HPV-16 cancers received a single dose of engineered T cells targeting HPV-16. Engineered TCR was expressed by upto 99 percent of the infused T cells in the initial 6 patients and the modified T cells were detectable in the peripheral blood six weeks following treatment.
Partial clinical responses were observed in 3 out of the 7 evaluable patients and the responses lasted as long as nine months and have occurred in patients with vulvar, oropharyngeal and anal cancer. The most common grade 3 or higher adverse events were anemia, lymphopenia, leukopenia and neutropenia, each of which occurred in all seven evaluable patients.
The trial is part of a Cooperative Research and Development Agreement between NCI and Kite to further the research and clinical development of TCR product candidates for the treatment of HPV-associated cancers.
Dr Alessandro Riva, Gilead’s Executive Vice President, Oncology Therapeutics & Head, Cell Therapy commented: “Findings from this Phase 1 study validate the E7 protein as a viral target for TCR therapy. We plan to submit an IND for our TCR candidate, KITE-439, for HPV-16 E7 solid tumors by the end of the year, and we continue to explore other potential TCR therapy candidates for a variety of cancers in partnership with the NCI.”
Source: Kite Announces Initial Results From a Phase 1 Study of T Cell Receptor (TCR) Cell Therapy in HPV-16-Positive Solid Tumors; Press Release