Iovance Biotherapeutics Announces First Patient Dosed in C-145-04 Phase 2 Trial in Cervical Cancer

SAN CARLOS, Calif., Aug. 16, 2017 -- Iovance Biotherapeutics, Inc. (NASDAQ:IOVA), a biotechnology company developing novel cancer immunotherapies based on tumor-infiltrating lymphocyte (TIL) technology, today announced that the first patient was dosed in its C-145-04 Phase 2 trial of LN-145 for the treatment of patients with recurrent, metastatic or persistent cervical carcinoma.

“This marks an important milestone for Iovance, as patient dosing is now ongoing in all three of our internal Phase 2 trials. We initiated this study based on encouraging data generated by the National Cancer Institute (NCI) showing responses in three of the nine cervical cancer patients treated with TIL therapy. This patient population had received standard of care treatment including prior chemotherapy or chemoradiotherapy. Two patients from this study continued to have a complete response at 46 months and 54 months of follow up. The C-145-04 trial will investigate the effect of Iovance’s TIL therapy in cervical cancer patients. We look forward to progressing the study with the intent to report some initial data in 2018,” said Dr. Maria Fardis, PhD, MBA, Chief Executive Officer of Iovance Biotherapeutics.

LN-145 is an adoptive cell transfer (ACT) therapy that utilizes an autologous TIL manufacturing process as originally developed by the NCI. C-145-04 is a Phase 2, multicenter, single-arm, open-label interventional study that will enroll up to 47 patients and will assess the safety and efficacy of LN-145 for the treatment of patients with recurrent, metastatic, or persistent cervical carcinoma. The cell transfer therapy used in this study involves patients receiving a non-myeloablative (NMA) lymphocyte depleting preparative regimen, followed by infusion of autologous TIL and the administration of a regimen of up to six doses of IL-2.

Additional information on this study is available at www.clinicaltrials.gov using the identifier number NCT03108495.

About Iovance Biotherapeutics, Inc.
Iovance Biotherapeutics, 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 lymphocyte (TIL) technology being investigated for the treatment of patients with metastatic melanoma, recurrent and/or metastatic squamous cell carcinoma of the head and neck and recurrent and metastatic or persistent cervical cancer. For more information, please visit http://www.iovance.com.

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