Iovance Biotherapeutics Announces Breakthrough Therapy Designation for LN-145 for Treatment of Advanced Cervical Cancer Patie...
May 22 2019 - 4:30PM
Iovance Biotherapeutics, Inc. (NASDAQ: IOVA), a late-stage
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 Breakthrough Therapy designation to Iovance TIL
therapy candidate LN-145 in recurrent, metastatic, or persistent
cervical cancer with disease progression on or after chemotherapy.
“We are very excited that the FDA has granted LN-145 in advanced
cervical cancer Breakthrough Therapy designation. Cervical cancer
patients who have progressed on or after chemotherapy have limited
treatment options. We hope to bring LN-145 to these patients as
quickly as possible,” commented Maria Fardis, Ph.D., MBA, president
and chief executive officer of Iovance. “The designation allows us
to expedite our development program through more frequent
interactions with the FDA and provides eligibility for rolling
review and priority review.”
Breakthrough Therapy designation (BTD) is designed to
expedite the development and review of therapeutic candidates
intended to treat serious or life-threatening diseases in the case
where preliminary clinical evidence indicates that the drug may
demonstrate substantial improvement over available therapy on a
clinically significant endpoint. The FDA decision on BTD for LN-145
in advanced cervical cancer was based on clinical data from the
ongoing innovaTIL-04 (C-145-04) trial. The company will present the
data on June 1, 2019, at the American Society of Clinical Oncology
(ASCO) Annual Meeting.
About Iovance Biotherapeutics, Inc.
Iovance Biotherapeutics intends to commercialize lifileucel, an
autologous cell therapy product using TIL technology that amplifies
the body’s own immune response to eradicate solid tumors or attack
blood cancers. The company is currently conducting the pivotal
study innovaTIL-01 in patients with metastatic melanoma. In
addition, the company’s TIL therapies are being investigated for
the treatment of patients with locally advanced, recurrent or
metastatic cancers including cervical, head and neck, and non-small
cell lung cancer. For more information, please visit
www.iovance.com.
Forward-Looking Statements
Certain matters discussed in this press release are
“forward-looking statements” of Iovance Biotherapeutics, Inc.
(hereinafter referred to as the “Company,” “we,” “us,” or “our”).
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. The forward-looking
statements include, but are not limited to, risks and uncertainties
relating to the success, timing, projected enrollment,
manufacturing and production capabilities, and cost of our ongoing
clinical trials and anticipated clinical trials for our current
product candidates (including both Company-sponsored and
collaborator-sponsored trials in both the U.S. and Europe), such as
statements regarding the timing of initiation and completion of
these trials; the timing of and our ability to obtain and maintain
FDA or other regulatory authority approval of, or other action with
respect to, our product candidates, including those product
candidates that have been granted Breakthrough Therapy designation
(BTD) by the FDA; the strength of the Company’s product pipeline;
the successful implementation of the Company’s research and
development programs and collaborations; the Company’s ability to
obtain tax incentives and credits; the success of the Company’s
manufacturing, 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. Actual results may differ from those set forth in this
press release due to the risks and uncertainties inherent in the
Company’s business, including, without limitation; the preliminary
clinical results, including efficacy and safety results, from
ongoing Phase 2 studies may not be reflected in the final analyses
of these trials, including new cohorts within these trials, and may
not be supportive of product approval; the FDA or other regulatory
authorities may potentially delay the timing of their approval of,
or other action with respect to, the Company’s product candidates;
the Company’s ability to address FDA or other regulatory authority
requirements relating to its clinical programs and registrational
plans, such requirements including, but not limited to, clinical
and safety requirements as well as manufacturing and control
requirements; risks related to the Company’s ability to maintain
and benefit from accelerated FDA review designations, including
BTD, which may not ultimately result in a faster development
process or review of the Company’s product candidates (and which
may later be rescinded by the FDA if such product candidates no
longer meet the conditions for qualification for the program), and
does not in any way assure approval of such product candidates by
the FDA or the ability of the Company to obtain FDA approval in
time to benefit from commercial opportunities; and the ability of
the Company to manufacture its therapies using third party
manufacturers. 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 circumstances.
Iovance Investor Relations Contacts:
Annie ChangSolebury Trout646-378-2972achang@troutgroup.com
Chad RubinSolebury Trout646-378-2947crubin@troutgroup.com
Iovance Media Relations Contact: Rich
AllanSolebury Trout646-378-2958rallan@troutgroup.com
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