Iovance Biotherapeutics Announces First Patient Dosed in C-145-04 Phase 2 Trial in Cervical Cancer
August 16 2017 - 7:00AM
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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developments to be materially different from those expressed in or
implied by such statements. A further list and description of
the Company’s risks, uncertainties and other factors can be found
in the Company’s most recent Annual Report on Form 10-K and the
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Investor Relations Contact:
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Stern Investor Relations, Inc.
212-362-1200
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FTI Consulting
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