$LBIO Announces Allowance of IND Application to Begin Clinical Trials


Lion Biotechnologies Announces Allowance of IND Application to Begin Clinical Trials in Cervical, Head and Neck Cancers

 Lion Biotechnologies, Inc. (LBIO), a biotechnology company that is developing novel cancer immunotherapies based on tumor-infiltrating lymphocytes (TIL), today announced that the US Food and Drug Administration (FDA) has allowed its investigational new drug (IND) application to conduct clinical trials of LN-145 in the treatment of cervical cancer, and head and neck squamous cell carcinoma (HNSCC).

Each of the single-arm studies will be conducted at up to six sites in a total of 10 patients with either recurrent or metastatic HNSCC, or recurrent or metastatic cervical carcinoma. The objectives of the studies are to assess safety, tolerability and various indicators of efficacy.

“Having received FDA clearance to begin these new trials, we look forward to expanding not only our pipeline, but also the number of patients who may benefit from TIL therapy,” said Elma Hawkins, PhD, Lion’s president and chief executive officer. “In preclinical studies, TIL have demonstrated encouraging anti-tumor activity in both cervical and HNSCC, illnesses for which new treatment options are urgently needed. We look forward to further investigating these findings in the clinical setting.”

About Lion Biotechnologies

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, and is based on a clinical Cooperative Research and Development Agreement with the National Cancer Institute. TIL therapy is also being evaluated in physician-sponsored clinical trials at MD Anderson Cancer Center and Moffitt Cancer Center. For more information, please visit http://www.lionbio.com.

Forward Looking Statements

This press release contains certain forward-looking statements that are subject to a number of risks and uncertainties described in the Company’s most recently filed quarterly report on Form 10-Q and annual report on Form 10-K. Except as permitted 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.

Investor Relations Contact
Molly Henderson
Chief Financial Officer


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