Iovance Biotherapeutics, Inc a biotechnology company developing novel cancer immunotherapies based on tumor-infiltrating lymphocyte (TIL) technology,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.
