Date: 2016-08-24
Type of information: Development agreement
Compound: combination of tumor-infiltrating lymphocytes (TIL) with FDA-approved drugs, such as checkpoint inhibitors
Company: Lion Biotechnologies (USA - CA) National Cancer Institute (NCI) (USA)
Therapeutic area: Cancer - Oncology
Type agreement: development
Action mechanism: cell therapy/immunotherapy product.
Disease: melanoma, bladder cancer, lung cancer, triple-negative breast cancer, HPV-associated cancers (including cervical and head and neck cancers)
Details: * On August 24, 2016, Lion Biotechnologies announced an amendment of its Cooperative Research and Development Agreement (CRADA) with the National Cancer Institute (NCI) to extend the CRADA for an additional five-year term until 2021. Under the extended CRADA, the Company will continue working with Steven A. Rosenberg, M.D., Ph.D., chief of NCI's Surgery Branch, to develop TIL which have not been genetically altered as a stand-alone therapy or in combination with FDA-licensed products routinely used for treatment of the indications covered under the CRADA. The CRADA includes the development of TIL therapy for the treatment of metastatic melanoma, bladder, lung, breast, and HPV-associated cancers. Under the CRADA, combination of TIL with FDA-approved drugs, such as checkpoint inhibitors, will be explored. The financial terms of CRADA were not changed. The CRADA, originally entered into in August 2011 for the development of TIL therapy in the treatment of metastatic melanoma, was previously amended in January 2015, to increase its annual funding and to include four additional indications. * On January 26, 2015, Lion Biotechnologies announced that its existing Cooperative Research and Development Agreement (CRADA) with the National Cancer Institute (NCI) has been amended to include four new tumor indications for TIL therapy. Under the modified terms of the CRADA, the NCI has granted Lion the rights to develop TIL therapy for the treatment of bladder, lung, triple-negative breast and HPV-associated cancers (including cervical and head and neck cancers), in addition to the company's current programs in metastatic melanoma. Furthermore, the NCI has agreed to provide Lion with samples of all tumors covered by the amendment for performing studies related to improving TIL selection and/or TIL scale-out production and process development. To fund the NCI's expanded development efforts and support, Lion will increase its annual payments to NCI from $1 million to $2 million.
Financial terms:
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