“Based on the encouraging data we have seen thus far for TIL therapy in this indication, we have initiated a Phase 2 trial of Lion’s TIL therapy in metastatic cervical cancer to investigate the responses seen in the NCI trial in a larger number of cervical cancer patients. However, patient selection in our ongoing Phase 2 trial is not limited by the presence of HPV, as the study is designed to allow a broader patient population to be enrolled,” said Maria Fardis, PhD, MBA, President and Chief Executive Officer of Lion Biotechnologies.
Data from the NCI clinical trial was previously presented at the 2014 meeting of the American Society of Clinical Oncology Annual Meeting. These data indicated that a single infusion of TIL therapy generated two complete and durable remissions, ongoing at 15 and 22 months at the time of presentation. A third patient was reported to have achieved a partial three-month response with a 39% reduction in tumor volume.
The new translational study published in Science further evaluated the two patients with ongoing complete remissions. These data demonstrated that the antitumor activity of these patients’ TIL targeted both viral and non-viral tumor antigens.
Dr. Christian Hinrichs, the lead investigator of the trial at NCI’s Center for Cancer Research (CCR) said, “Our research shows the importance of not only viral but also non-viral antigens in immunotherapy for cervical cancer. These findings have important implications for how we design and study new treatments for this disease.”
About Lion Biotechnologies, Inc.
Lion Biotechnologies, Inc. is a clinical-stage biotechnology company focused on the development of cancer immunotherapy products for the treatment of various cancers. The Company’s lead product candidate is an adoptive cell therapy using tumor-infiltrating lymphocytes (TIL) for the treatment of patients with refractory metastatic melanoma. TIL therapy is also being evaluated in clinical trials at the National Cancer Institute, MD Anderson and Moffitt Cancer Center. For more information, please visit http://www.lionbio.com.
This press release contains certain forward-looking statements that are subject to a number of risks and uncertainties, including the ability of Lion Biotechnologies (“the Company”) to successfully complete its Phase 2 trial of TIL therapy in metastatic cervical cancer, and the other risks described in the Company’s filings with the Securities and Exchange Commission, including without limitation in its most recently filed quarterly report on Form 10-Q and annual report on Form 10-K. Any forward-looking statements that the Company makes in this press release speak only as of the date of this press release. Except as required by law, the Company undertakes no obligation to update or revise any forward-looking statements, whether as a result of new information, future events or otherwise.