Iovance Biotherapeutics Announces FDA Fast Track Designation for LN-144 for Treatment of Advanced Melanoma
August 31 2017 - 4:47PM
Iovance Biotherapeutics, Inc. (NASDAQ:IOVA), a biotechnology
company developing novel cancer immunotherapies based on
tumor-infiltrating lymphocyte (TIL) technology, today announced
that the U.S. Food and Drug Administration (FDA) has granted Fast
Track designation for LN-144, the Company’s adoptive cell therapy
using its TIL technology, for the treatment of advanced melanoma.
“We are pleased that the FDA has granted Fast Track designation
to LN-144 for the treatment of advanced melanoma. The Fast Track
designation underscores that advanced melanoma remains a serious
condition and that LN-144 may have the potential to address this
unmet medical need,” said Dr. Maria Fardis, PhD, MBA, Chief
Executive Officer of Iovance Biotherapeutics. “We look forward to a
closer interaction with the FDA as we advance the clinical
development of LN-144 for the treatment of advanced melanoma.”
C-144-01 is a Phase 2 study evaluating LN-144, Iovance’s lead
product, for treatment of patients with metastatic melanoma. The
study is currently enrolling and is expected to enroll up to 60
patients in two cohorts: Cohort 1 allows for non-cryopreserved TIL
product to be administered to patients, while Cohort 2 involves
administration of a cryopreserved product. In June 2017, the
Company presented a poster at the 2017 American Society of Clinical
Oncology (ASCO) Annual Meeting with data from 16 patients enrolled
in the first cohort of this study. The data reported showed
clinically-meaningful outcomes in the evaluable patients, with a
29% Objective Response Rate (per RECIST v1.1) including one
complete response continuing beyond 15 months post-administration
of a single TIL treatment, and 77% of patients had reduction in
target tumor size. The Phase 2 study was conducted in a heavily
pre-treated patient group, all of which had received prior
anti-PD-1 therapy and 88% with prior anti-CTLA-4 checkpoint
inhibitors, with a median of three prior therapies.
The FDA's Fast Track process is designed to facilitate the
development, and expedite the review of drugs that treat serious
conditions and fill an unmet medical need. Fast Track designation
allows more frequent meetings and communications with the FDA to
discuss the drug's development plans and review process. The Fast
Track designation also allows for a rolling review of a company's
Biologic License Application (BLA).
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 McCabe
Stern Investor Relations, Inc.
212-362-1200
sarah@sternir.com
Media Relations Contact:
Evan Smith/Kotaro Yoshida
FTI Consulting
212-850-5622/212-850-5690
evan.smith@fticonsulting.com
kotaro.yoshida@fticonsulting.com
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