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Iovance Biotherapeutics Announces First Patient Dosed in Europe for Ongoing C-144-01 Phase 2 Trials in Metastatic Melanoma
SAN CARLOS, Calif., June 07, 2018 (GLOBE NEWSWIRE) -- 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 the ongoing C-144-01 Phase 2 trial of LN-144 (lifileucel) for the treatment of patients with metastatic melanoma at a clinical trial site in the United Kingdom.
“The dosing of the first patient with lifileucel in Europe for the treatment of metastatic melanoma marks an important milestone for Iovance and our global development plans as our European Union (EU) manufacturing is now able to support enrollment in that region,” said Dr. Maria Fardis, PhD, MBA, president and chief executive officer of Iovance Biotherapeutics. “This is a major step forward and we are excited by the opportunity to offer more patients TIL therapy around the world.”
In December 2017, the company announced that the Generation 2 manufacturing process, with a duration of 22 days, was selected and all studies were shifted to utilize that method of manufacturing. The company has manufacturing capability in both the US and EU. This is the first patient treated with TIL developed in an EU-based manufacturing facility.
C-144-01 is a Phase 2 multicenter study evaluating the safety and efficacy of autologous tumor infiltrating lymphocytes (lifileucel), Iovance’s lead product candidate for treatment of patients with metastatic melanoma. The study is currently enrolling in the United States and Europe. To date, Iovance has over 25 active clinical sites in the United States and Europe. The sample size for enrollment was increased to 85 for this study. Additional information on this study is available at www.clinicaltrials.gov using the identifier number NCT02360579.
About Iovance Biotherapeutics, Inc.
Iovance Biotherapeutics, Inc. (the Company) 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 TIL technology being investigated for the treatment of patients with metastatic melanoma, recurrent and/or metastatic squamous cell carcinoma of the head and neck, recurrent, metastatic or persistent cervical cancer and locally advanced or metastatic non-small cell lung cancer. For more information, please visit http://www.iovance.com.
Certain matters discussed in this press release are “forward-looking statements”. We may, in some cases, use terms such as “predicts,” “believes,” “potential,” “continue,” “estimates,” “anticipates,” “expects,” “plans,” “intends,” “may,” “could,” “might,” “will,” “should” or other words that convey uncertainty of future events or outcomes to identify these forward-looking statements. In particular, the Company’s statements regarding trends and potential future results are examples of such forward-looking statements. The forward-looking statements include risks and uncertainties, including, but not limited to, the success, timing and cost of our ongoing clinical trials and anticipated clinical trials for our current product candidates, including statements regarding the timing of initiation and completion of these trials; the timing of and our ability to obtain and maintain U.S. Food and Drug Administration or other regulatory authority approval of, or other action with respect to, our product candidates; the strength of Company’s product pipeline; the successful implementation of the Company’s research and development programs and collaborations; the success of the Company’s license or development agreements; the acceptance by the market of the Company’s product candidates, if approved; and other factors, including general economic conditions and regulatory developments, not within the Company’s control. The factors discussed herein could cause actual results and 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 Company's subsequent filings with the Securities and Exchange Commission. Copies of these filings are available online at www.sec.gov or www.iovance.com. The forward-looking statements are made only as of the date of this press release and the Company undertakes no obligation to publicly update such forward-looking statements to reflect subsequent events or circumstance.
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