Iovance Biotherapeutics Announces First Patient Dosed in Europe for Ongoing C-144-01 Phase 2 Trials in Metastatic Melanoma
June 07 2018 - 8:01AM
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.
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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.
Investor Relations Contact: Sarah McCabe Stern
Investor Relations, Inc. 212-362-1200 sarah@sternir.com
Media Contact: Evan Smith FTI Consulting
212-850-5622 evan.smith@fticonsulting.com
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