Iovance Biotherapeutics Announces Approval of First Clinical Trial Application by Competent Authority in Netherlands for a Ph...
September 13 2017 - 8:00AM
Iovance Biotherapeutics, Inc. (NASDAQ:IOVA), a biotechnology
company developing novel cancer immunotherapies based on
tumor-infiltrating lymphocyte (TIL) technology, today announced the
approval of the Company’s Clinical Trial Application (CTA), by the
competent authority (CA) in the Netherlands, for a Phase 2 trial of
LN-145 for the treatment of patients with recurrent, metastatic or
persistent cervical carcinoma. Iovance initiated the submission of
CTAs in multiple countries in Europe starting in August 2017 in
support of clinical trials in cervical carcinoma and metastatic
melanoma.
“We intend to use the data from our Phase 2 trials in support of
global registration for TIL therapy to treat patients with melanoma
and cervical carcinoma. We are very enthusiastic to have our first
CTA approved by the CA and look forward to initiating our trials in
Europe to offer TIL therapy to these metastatic melanoma and
cervical carcinoma patients in addition to those in the US. The
encouraging data generated by the National Cancer Institute showing
responses in three of the nine cervical cancer patients treated
with TIL therapy, with two continuing to have a complete response
at 46 months and 54 months of follow up, supports the potential for
LN-145 in the treatment of cervical cancer,” said Dr. Maria Fardis,
PhD, MBA, President and Chief Executive Officer of Iovance
Biotherapeutics.
LN-145 is an adoptive cell transfer (ACT) therapy that utilizes
an autologous TIL manufacturing process. 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.
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.
Forward-Looking Statements 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 the 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 McCabeStern
Investor Relations, Inc.212-362-1200sarah@sternir.com
Media Relations Contact:Evan Smith/Kotaro
YoshidaFTI Consulting212-850-5622/212-850-5690
evan.smith@fticonsulting.comkotaro.yoshida@fticonsulting.com
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