Iovance Biotherapeutics Provides Cervical Cancer Program Updates Following End of Phase 2 Meeting with U.S. Food and Drug Adm...
July 02 2019 - 7:30AM
Iovance Biotherapeutics, Inc. (NASDAQ: IOVA), a late-stage
biotechnology company developing novel cancer immunotherapies based
on tumor-infiltrating lymphocyte (TIL) technology, today provided
an update on the regulatory path for LN-145 in advanced cervical
cancer. Based on an End of Phase 2 meeting held with the U.S. Food
and Drug Administration (FDA), the FDA has acknowledged that the
ongoing innovaTIL-04 study of TIL therapy LN-145 may be sufficient
to support registration in the treatment of patients with advanced
cervical cancer. The study is being enrolled with a prospective
definition of objective response rate (ORR) read out by a Blinded
Independent Review Committee (BIRC) as the primary endpoint.
In accordance with the FDA’s recommendation, the new version
of the protocol will further define the patient population. Iovance
plans to include in the Biologics License Application (BLA),
patients who have progressed following initial systemic therapy for
recurrent or metastatic disease, which constitutes almost all of
the more advanced patients enrolled to date. In addition, the
company announced that the innovaTIL-04 study is expected to enroll
a total of 75 to 100 patients in order to support a BLA submission.
“The FDA’s agreement to consider acceptability of the ongoing
study in patients with cervical cancer significantly accelerates
our path to BLA submission for LN-145,” said Maria Fardis, Ph.D.,
president and chief executive officer of Iovance Biotherapeutics.
“This feedback is encouraging. The ability to use the current
study, as well as the Breakthrough Therapy designation recently
granted to LN-145, allows us to plan on a path to BLA submission in
the second half of 2020.”
About Iovance Biotherapeutics, Inc.
Iovance Biotherapeutics intends to commercialize autologous cell
therapy products that amplify 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 tumor
infiltrating lymphocyte (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”) or regenerative medicine advanced therapy designation
(“RMAT”) 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, which may include efficacy and safety results,
from ongoing Phase 2 studies may not be reflected in the final
analyses of these trials; the rate of enrollment may impact the
Company’s clinical trial timelines; enrollment may need to be
adjusted for the Company’s trials and cohorts within those trials
based on FDA and other regulatory agency input; the new version of
the protocol which further defines the patient population to
include more advanced patients in the Company’s cervical cancer
trial may have an adverse effect on the results reported to date;
the data within these trials may not be supportive of product
approval; 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, safety, manufacturing and control requirements; the
Company’s interpretation of communications with the FDA; risks
related to the Company’s ability to maintain and benefit from
accelerated FDA review designations, including BTD and RMAT, which
may not result in a faster development process or review of the
Company’s product candidates (and which may later be rescinded by
the FDA), and does not 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.
Investor Relations Contacts: Annie
ChangSolebury Trout646-378-2972achang@troutgroup.com
Chad RubinSolebury Trout646-378-2947crubin@troutgroup.com
Media Relations Contact: Rich AllanSolebury
Trout646-378-2958rallan@troutgroup.com
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